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N° X • XXXXXXXX 2008XXX SEPTEMBER • 2011MEDICAL DEVICES NEWS

Keeping up to date in the Medical Devices industry is a challenge. Specific regulations and standards govern all MD products and their respective markets function under unique rules. Knowing how to ensure your products meet these rules, or how you pace product development and market launch activities to best advantage, is the key to success.

SGS Medical Devices Newsletter saves you time by presenting the latest news a click away. Scan the titles and get instant access to the most important issues for you and your business. Our goal is to help you stay informed and ahead of the competition. The right knowledge can make all the difference in increasing your global reach in the MD industry.

Explore the Newsletter to find the latest information on current MD issues, including: new regulations in Saudi Arabia; market access related to CE marking; the new best practice Code of Conduct for Notified Bodies; the Recast; and new requirements for IEC 60601-1-11.

We hope you find Issue 2 informative and useful!

MEDICAL DEVICES NEWS SEPTEMBER 2011

P. 2N° X • XXXXXXXX 2008XXX P. 2SEPTEMBER • 2011

THE NEW INTERNATIONAL STANDARD FOR HOME HEALTHCARE ELECTRO-MEDICAL DEVICES

MEDICAL DEVICES NEWS

For the first time IEC has published a standard specifically defining the requirements for devices used in the home healthcare environment. IEC 60601-1-11 (2010) must now be incorporated into the design and verification of a wide range of home use and point of care medical devices along with other applicable standards in the IEC 60601 third edition series.

MANDATORY DATES FOR IEC 60601-1-11

The mandatory date for implementation of the EN European version of the standard is June 1, 2013. Health Canada and the US FDA require mandatory use of the entire IEC 60601 third edition series including -1-11 by June 1, 2012 and June 30, 2013 respectively. The North American agencies only require these standards to be adhered to for new device submissions, while the EU is taking a more severe approach. The EU requires all applicable devices placed on the market to take the home healthcare standard into consideration. As a result, manufacturers need to design or redesign devices to meet this standard now.

SCOPE OF IEC 60601-1-11

The scope of the standard defines the Home Healthcare Environment as:

“Dwelling place in which a patient lives or other places where patients are present, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present.”

While this definition includes outdoors and in vehicles, what may be surprising is that nursing homes are also considered a Home Healthcare Environment. The standard applies whether the device is used by a ‘Lay Operator’ or by trained healthcare personnel. Examples of device types that would typically use this new standard are devices prescribed for home use such as oxygen concentrators, body worn nerve

and muscle stimulators, beds, sleep apnea monitors, and associated battery chargers. The standard does not apply to home use in vitro diagnostic devices such as blood glucose meters. In vitro devices use the more lenient IEC 61010 series, yet they are being used under the same environmental conditions and by the same patients.

HOW TO COMPLY WITH IEC 60601-1-11

In order to comply, there are significant areas in which the standard differs from the general IEC 60601-1 in both construction and test requirements. The device operator, who is often the patient or a member of the patient’s family, is obviously different from the better-trained and educated specialist in a hospital. Risk Management also has to take into account children, pets, and the various locations the device can be used in the home that are not present in a hospital (such as near a fireplace). With the home environment in mind, controls relating to safety and performance must be protected from accidental or unauthorized changes or adjustments.

Additional requirements for cleaning, disinfection, and sterilization of the device places a particular emphasis on the manufacturer’s usability engineering process and file. This is due to the lay operator’s involvement in these activities. The standard assumes a maximum of eight years of education for the lay operator, so the instructions, markings, and device should be designed around that level of education or less.

Usability for the device must meet the requirements of the collateral standard IEC 60601-1-6, preferably the 2010 third

edition. It is our experience that manufacturer’s Risk Management Files often lack usability in comparison to those of better-understood phenomena such as electric shock and biological hazards.

HARDWARE REQUIREMENTS OF IEC 60601-1-11

On the hardware side the standard requires the use of a two-prong (unearthed) plug, patient applied parts that are isolated from other parts of the device, and an enclosure that is resistant to rain and fluid spills. Failure to adequately prevent water ingress is common, so a pretest of the enclosure design is recommended in the prototype stage.

Home healthcare devices have added requirements for mechanical shock, vibration, and impact from dropping that are typical for devices outside of the more controlled environment of a healthcare facility. Compliance is determined by verifying that safety and essential performance are maintained. These requirements are unlike anything in the general 60601-1 standard.

REVIEW OF EXISTING DEVICES RECOMMENDED

In summary, a thorough review of existing devices on the European market or new designs to be placed on the mar-ket in several countries is recommended. In order to meet the dates required for North America and the EU, this activity should be started now.

Contact [email protected] today to see how we can help your business.

mailto:medicaldevices%40sgs.com?subject=

P. 3N° X • XXXXXXXX 2008XXX P. 3SEPTEMBER • 2011MEDICAL DEVICES NEWS

IMPROVING THE PERFORMANCE OF NOTIFIED BODIES

With encouragement from the EC Commission a ‘Code of Conduct for Notified Bodies’ has been written and recently signed by an initial group of 11 Notified Bodies, including SGS United Kingdom Limited as Notified Body 0120. The Code of Conduct will be independently audited to ensure compliance.

CODE OF CONDUCT FOR NOTIFIED BODIES

This first issue covers: Qualification and assignment of auditors and technical file reviewers; a standard method for calculation of audit times and technical file review times; how to sample technical files for Class IIa and IIb devices; the depth of review for class IIa, IIb and III technical documentation; subcontracting; what expertise must be in house and; competence of the certification decision maker.

OBJECTIVE OF THE CODE OF CONDUCT

The objective of the Code of Conduwct is not to stop competition and efficiency improvements but to highlight and then stop the practice where most bodies would require five days for an audit but one body decides they only need two days; or where a Notified Body uses a technical file reviewer with no experience of the device or its use.

INCREASED CONFIDENCE IN CERTIFICATION

Certification at a level below that which can provide confidence risks devaluing the certification and approval of the vast majority of manufacturers who wish to achieve true compliance and a safe and performing product.

CODE OF CONDUCT AVAILABLE VIA SGS WEBSITE

As the Code of Conduct is based on current best practice of the leading Notified Bodies customers of certification bodies such as SGS, should not see significant differences in operation. A joint Press Release has been published. Future editions of the SGS Medical Devices Newsletter will contain further articles on this subject.

For a copy of the Code of Practice, please request one from SGS via [email protected].



EUROPE IS NOT A PERFECT SINGLE MARKET

Manufacturers in Europe and exporters to Europe must take care and not think that CE marking will give them a legal right to sell medical devices in every European country.

Whereas the USA, Japan and most other countries have a single Medical Device Regulatory Authority, Europe has 32 Competent Authorities. So for a few products the European Competent Authorities do not agree on whether a product is a medical device, a drug or even a consumer product. For some medical devices they do not agree on the classification.

PRODUCT CATEGORY DIFFERENCES

Examples of products that are considered devices in some countries and not others include dermal fillers for cosmetic use, medical gas pipeline installations and tooth whiteners. For such products it is the responsibility of the manufacturer to check the current legal status in each country where the product is to be sold. This is to avoid possible legal action being taken against them. For the most up to date information and interpretations on a product’s legal status in a given country manufacturers you are best to use local contacts or distributors.

DIFFERENCES IN CLASSIFICATION OF MEDICAL DEVICES

When differences in classification occur, where the same conformity assessment option is possible (i.e. a device being IIa or IIb under MDD), there is not usually a significant problem. Where the differences necessitate a different conformity assessment option under MDD or IVDD this is a problem. Examples of such devices include saline washes that can be Class IIa or Class III depending on the country; and point of care pharmacy blood analysis services which can be considered self test devices or for professional use dependent on the country.

ALWAYS STAY INFORMED AND AWARE OF DIFFERENCES

This should not dissuade you from trying to sell your medical devices in the €100 billion medical device market but manufacturers must be aware of products where there are different interpretations and inform sales or export departments to take care. Normally SGS can indicate to clients the products where there are known country differences, however as specific country status does change, the position in individual countries must be the final responsibility of the legal manufacturer or Authorised Representative.




THE RECAST UPDATE

The EC Commission is in the process of revising Directives 93/42/EEC (MDD), 98/79/EC (IVDD) and 90/385/EEC (AIMDD). Within Europe, this is known as the Recast, which suggests a major change in the directives. The effect on manufacturers is not imminent, but cannot be ignored. Recent discussions with, and presentations by, members of the EC Commission and the Medical Devices Expert Group (MDEG) have indicated some likely changes to be achieved through evolution not revolution. Proposals are likely to be published in 2012, with two new directives following in 2014 and then full implementation in 2016.

BACKGROUND TO THE RECAST

The Recast of the directives is in response to the predicted increase in European health costs, resulting from current demographic changes. Through the amendments made in the Recast, the EU aims to deliver a high level of patient protection while controlling costs. Hence, one focus is on the promotion of prevention and early diagnosis, point of care/home use devices and innovation.

It is also accepted that there is too large a difference in the approach and competence of Notified Bodies.

LIKELY FEATURES OF THE RECAST

The following features are probable inclusions in the revised directives:

• The MDD and AIMDD will be combined but the IVDD will still be a separate directive.

• There will be more central control over Notified Bodies imposing higher competency levels. The EC Commission acknowledges that this will result in some of the current 73

Notified Bodies disappearing, having their scope reduced or having to significantly increase their competency.

• Invasive devices for purely cosmetic use (e.g. dermal fillers, cosmetic contact lenses) will be included and will be CE marked but other lower risk cosmetic products such as body piercings and tattoos will remain excluded.

• Some devices containing non-viable human cells and tissues (e.g. demineralized bone matrix) will be included and assessed in the same way as devices with animal tissues are currently assessed.

• Some genetic tests will be considered as IVDs and will be CE marked.

• The coordination of the review and approval of Clinical Investigations will be improved to aid multi-centre studies.

• In line with a global initiative there may be a requirement for an as yet unspecified Unique Device Indicator

(UDI) starting with Class III devices.• There will be a mechanism for a

more consistent approach to Vigilance from the Competent Authorities

• There will be a more consistent approach to borderline technology (e.g. nanotechnology) to minimize divergence between member states.

IMPACT ON IVD MANUFACTURERS

Based on the recent EC Commission Public Consultation(1) on the IVD Directive, a modified risk based classification approach will bring a much wider range of IVD’s under Notified Body certification. This is the biggest potential impact for IVD manufacturers. There will also be a greater emphasis on clinical evidence and clinical validity for IVD device performance.

REVIEW LONG-TERM PLANS

SGS is not recommending action from manufacturers at this stage. However manufacturers who are not certified by one of the major well qualified Notified Bodies, such as SGS, may wish to reconsider their long-term plans for CE marking. In addition, manufacturers of IVD devices likely to be re-classified may wish to start to prepare for the Recast by ensuring that all devices are covered by ISO 13485 certification from a Notified Body.

SGS is fully involved in dialogue with the EC Commission about the Recast. This includes participation in the management of NB MED and TEAM NB, as well as in the IVDD working group. So, further updates will be provided as the Recast develops.


REFERENCES European Commission - Revision of Directive 98/79/EC on In Vitro Diagnostic Medical Devices - Summary of responses to the public consultation 23 February 2011 http://ec.europa.eu/consumers/sectors/medical-devices/files/recast_docs_2008/ivd_pc_outcome_en.pdf


http://ec.europa.eu/consumers/sectors/medical-devices/files/recast_docs_2008/ivd_pc_outcome_en.pdf




NEW REGULATIONS IN SAUDI ARABIA

Previously there were no restrictions on the importation and sale of medical devices, although the Gulf Co-operation Council (GCC) audited some manufacturers as an entry requirement for large state-funded tenders.

In 2009, the medical devices sector of the Saudi Food and Drug Authority (SFDA) published the Medical Devices Interim Regulations. These included implementation dates, now amended to August 14 and December 31, 2011 (as described later). Despite the Interim title, the expectation is that these regulations will be in place for at least 5 years. They impose requirements on importers, distributors, authorised representatives, overseas manufacturers and local manufacturers. This article summarizes these regulations, focusing on those affecting overseas manufacturers.

The KSA Interim Regulations use the recognition of existing Global Harmonization Task Force (GHTF) approvals. They are based on the GHTF requirements of Europe, USA, Canada, Japan and Australia so many basic features are familiar to medical device

manufacturers.

The market for medical devices in the Kingdom of Saudi Arabia (KSA) has exhibited many years of growth and is currently estimated at US$3.5 billion (€2.4 billion) per year, almost all imported. As a result, the implementation of the first KSA regulations applying to the medical devices industry has global significance.

SCOPE OF REGULATIONS

The Regulations have adopted the global definition of a medical device, with wording similar to the GHTF/EC/Australian/Canadian text. In the KSA, active implantable, general and in vitro diagnostic medical devices and their accessories are included in this one regulation. Additionally, contact lenses and lasers used for cosmetic purposes are included. The regulations do not apply to equipment already in use but will eventually apply to unused stock within the KSA.

REQUIREMENTS ON KSA OPERATORS

A web-based Medical Devices National Registry (MDNR) has been established as a result of the Interim Regulations. This includes establishment and medical device registration and listings. Within the MDNR, all KSA importers, distributors, authorised representatives and local manufacturers must be KSA legal entities and obtain an establishment license for their appropriate operations. Each of these operations is seen as a separate process, for example an authorised representative

may or may not also be the importer or distributor of a device. Overseas manufacturers may wish to check that their KSA partners have obtained the necessary licenses.

AUTHORISED REPRESENTATIVES NEEDED

All overseas manufacturers must appoint a KSA Authorised Representative (AR). This AR undertakes all the duties under the Interim Regulations on behalf of the manufacturer and represents them to the SFDA. One of these tasks is the application for marketing authorizations. Appointment of the AR must be complete before any device application can be made. The appointment is based on an establishment license for the AR and a specific agreement or mandate between the two parties. The SFDA Guidance for Medical Devices Authorised Representatives includes a recommended model agreement.

MARKETING AUTHORIZATION THROUGH AUTHORISED REPRESENTATIVES

Once appointed, the AR can apply for marketing authorizations on behalf of the


manufacturer via the SFDA web-based system. Each application is for a single device or a family of devices with the same purpose and mode of operation. Fees vary from US$4,000 to US$6,700 (€2,800 to €4,700) per application. The information required for each application is normally supplied by the manufacturer and based on an existing device approval of their choice, either from Europe, the USA, Japan, Canada or Australia. The AR uploads information on behalf of the manufacturer, including: documentation to show a GHTF approval (classification, certification, declarations, registrations, notified body report etc); KSA labeling; a manufacturers declaration; information on transport, storage, environmental and electricity supply requirements; and any KSA advertising material.

Marketing authorization is granted by the SFDA but they involve a small number of appointed Conformity Assessment Bodies (CAB) such as SGS to support them. However, the manufacturer does not have a choice of CAB and there is no direct manufacturer/CAB communication in the marketing authorization process. Once authorization has been obtained, manufacturers are free to ship to, and sell devices in, the KSA.

DEADLINES AND ACTIONS

The official announcement, 12/10/MDA-AN001, published on 12/29/2010, changed the original implementation dates. The announcement states:

“After 14 August 2011, only medical devices that have a SFDA marketing authorization may be placed on the market within KSA.”

SGS understands this as applying to all imports for the purpose of sale in the

KSA and in particular to devices new to the KSA market.

It also states:

“After 31 December 2011, only medical devices that have a SFDA marketing authorization may be put into service within the KSA.”

SGS understands this as applying to the use of medical devices already imported legally into the KSA.

There have been delays with the AR licensing system and of obtaining marketing authorizations, although the system is now operational. Therefore, all the marketing authorizations will not be issued in time to meet either of the deadlines and there may have to be a degree of flexibility in the system. However, to avoid problems at the KSA customs and with the SFDA, overseas manufacturers who currently sell in the KSA must ensure they have an appointed licensed AR, and that applications for marketing authorization are made as soon as possible. Manufacturers entering the KSA market for the first time must ensure the total process is complete before shipping the first batch of devices.

The SFDA has emphasized – in August 2011 – to those CABs working with them the importance of compliance to the new regulations. They have asked CABs, such as SGS, to contact all customers and manufacturers and inform them of the new regulations and the urgency of compliance. To quote the SFDA news bulletin:

“It is therefore important for any manufacturer wishing to place goods on the Saudi market to engage with the process in place at the SFDA without

delay. It is likely that failure to either have approval or to be in the process of approval could result in products being prevented from either entering the country or being sold or used”

Saudi Food and Drug Authority – August 24, 2011

FURTHER INFORMATION

The SFDA website http://www.sfda.gov.sa/En/MedicalEquipments/Top-ics/interim+E.htm, is a good source of official information in particular the Regulations and Guidelines and Official Announcements sections. Manufacturers outside KSA should first read Guidance for Overseas Manufacturers, Guidance on Marketing Authorization Procedure and Guidance for Medical Devices Authorised Representatives.


http://www.sfda.gov.sa/En/MedicalEquipments/Topics/interim%2BE.htm




P. 8N° X • XXXXXXXX 2008XXX P. 8 SEPTEMBER • 2011MEDICAL DEVICES NEWS

NEW ROHS II DIRECTIVE CONTAINS ALL THE AMENDMENTS EXPECTED

On July 1, 2011 the RoHS II Directive 2011/65/EU was published in the Official Journal of the European Union. All amendments made in this edition mirrored those in the preceding draft publication. For the full RoHS II Directive see: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:EN:PDFThe recast edition of the RoHS Directive contains all the updates that were proposed within the final draft document issued on November 24, 2010. This means that, as expected, any RoHS Directive items previously in question have now been clarified and as a result, RoHS II is now a CE Mark Directive. No new restricted substances have been introduced and the exemption of Medical Devices in the previous directive 2002/95/EC is being phased out over a transition period. As the directive continues to evolve, manufacturers, importers and distributers of medical devices all need to be aware of the implications the changing RoHS II will have on products over the coming years.

PHASE OUT PLAN FOR MEDICAL DEVICES EXEMPTIONS

In the new RoHS directive product exemptions from categories 8 and 9 are being gradually phased out. This includes medical devices (three years after RoHS II publication, category 8), in-vitro diagnostics (five years after RoHS II publication, category 8), control and monitoring devices (three years after RoHS II publication, category 9), industrial control and monitoring instruments (six years after RoHS II publication, category 9).

OUT OF THE GREY FOR ELECTRICAL AND ELECTRONIC EQUIPMENT

At the same time the new directive covers all but a very few instances of Electrical and Electronic Equipment (EEE). Annex I of the directive introduces a new, eleventh product category – Other EEE not covered by any of the categories above (categories 1–10). Further to this, EEE needing electric currents or electromagnetic fields to fulfill at least one intended function are expected to be included in the future. Thus, electrical and electronic equipment types that were not covered before are covered by RoHS II, including formerly grey zone items such as electric toys.

TIMESCALES FOR ADOPTION OF THE NEW DIRECTIVE

Formal adoption of RoHS II by the European Council occurred in early July

2011 with the directive becoming mandatory legislation 20 days after it was published in the Official Journal of the European Union. At that point, member states were given eighteen months to enforce the directive into law. Until this happens, the current RoHS directive 2002/95/EC remains in force. It needs to be considered though that some EU member states may have national laws in place automatically enforcing amendments of directive 2002/95/EC.

Following timelines of RoHS II this means that regular medical devices are in scope by mid 2014 and in-vitro diagnostic medical devices are in scope by mid 2016 at the latest.

LIMITED EXEMPTIONS REMAIN IN ROHS II

The RoHS II directive exempts ten general types of electrical and electronic equipment. Active implantable medical devices are among of them.

In addition to these exempt general types of EEE, there are still some specific exemptions of restricted substances in specific applications. Annex III and Annex IV define where otherwise restricted substances may be applied. Annex III lists general exemptions applicable to all EEE and Annex IV lists some additional exemptions only applicable to categories 8 and 9 EEE. However, all on-going exemptions now have expiration dates.

In order to enforce coherence with REACH legislation, a process for the exemption of substances has been introduced. This allows exemptions to be granted for periods of five to seven years, depending on product category. Interested parties have to make sure to re-apply for pro-longing exemptions in sufficient time.

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do%3Furi%3DOJ:L:2011:174:0088:0110:EN:PDF%0D




P. 9N° X • XXXXXXXX 2008XXX P. 9 SEPTEMBER • 2011MEDICAL DEVICES NEWS

ROHS II DEFINES HOMOGENEOUS MATERIAL

RoHS II introduces a definition of homogeneous material as being:

“One material of uniform composition throughout or a material, consisting of a combination of materials, that cannot be mechanically disjointed into different materials, meaning that the materials cannot be separated by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes.”

This overcomes the issue that the previous definition was adapted from that of the Technical Advisory Committee.

NO NEW RESTRICTED SUBSTANCES UNDER ROHS II

RoHS II introduces no new restricted substances. What it does, however, is to introduce a simplified mechanism for the review and amendment of the restricted substances list in the future. Substances highlighted for future review include: hexabromocyclododecane (HBCDD), phthalates (DEHP, BBP, DBP) and nanomaterials.

ROHS II IS NOW A CE MARK DIRECTIVE

RoHS II is now a CE Mark directive, which means that CE marking will be affixed to all finished products, as per Module A of Annex II of 768/2008/CE. With CE marking the responsibility is shared between manufacturers, importers and distributors; CE

declaration remains the manufacturer’s obligation, while importers and distributors must control the release of compliant products onto the EU market. As the RoHS II is included, the CE mark not only means that an electrical or electronic product complies with all applicable regulations - for example, the low voltage directive or the electromagnetic compatibility requirement – it also indicates compliance with the RoHS. Thus, product compliance and conformity assessment now includes the obligation to comply with RoHS. If RoHS compliance is not assured, the application of the CE mark violates EU law.

SGS can help ensure compliance with RoHS II. Its global restricted substances service enables full support of products with REACH, SHVC and other relevant international, national and regional regulations and legislation. SGS can also provide compliance assessment, which is essential for the preparation of the CE declaration of conformity.




STANDARDS AND GUIDELINES UPDATEA list of some of the most important standards and guidelines issued in 2011.This is not a comprehensive list of global medical device standards and guidelines. Instead, SGS aims to list documents of wide interest published since the end of 2010. Guidelines listed are those published in English that are of general interest to a wide range of manufacturers.

CONSIDERATIONS BEFORE PURCHASE OF A NEW STANDARD

Before manufacturers consider purchasing a new standard, they should assure themselves that it is the most appropriate version of publication (e.g. ISO or national version) and that where a standard has been reissued the changes are technically significant.

FUTURE UPDATES

Future SGS Standards and Guidelines Updates will list subsequently published documents but will not repeat those listed in this issue of the SGS Medical Devices Newsletter.

CURRENT POSITION ON EUROPEAN HARMONIZATION

For those manufacturers CE marking medical devices, European harmonization is an important step in the adoption of standards. The current position can be checked via the following links but be aware that updates to these lists were made in January 2011 and May 2011.

AIMD http://eur-lex.europa.eu/LexUriServ/Lex-UriServ.do?uri=OJ:C:2011:143:0001:0006:EN:PDF

MDD http://eur-lex.europa.eu/LexUriServ/Lex-UriServ.do?uri=OJ:C:2011:143:0007:0034:EN:PDF

IVDD http://eur-lex.europa.eu/LexUriServ/Lex-UriServ.do?uri=OJ:C:2011:185:0003:0006:EN:PDF

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do%3Furi%3DOJ:C:2011:143:0001:0006:EN:PDF










SGS SELECTED LIST OF STANDARDS AND GUIDELINES ISSUED IN 2011

EN STANDARDS

• Published March 2011 EN 13795:2011 – Surgical Drapes, Gowns and Clean Air Suits, Used as Medical Devices for Patients, Clinical Staff and Equipment: General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels EN 15986:2011 – Symbol for Use in the Labeling of Medical Devices: Requirements for labeling of medical devices containing phthalates

• Published April 2011 EN 60601-2-52:2010/AC:2011 – Medical Electrical Equipment: Particular requirements for basic safety and essential performance of medical beds (Part 2-52) EN 80001-1:2011 – Application of Risk Management: IT-networks incorporating medical devices

• Published May 2011 EN 13976-1:2011 – Rescue Systems: Transportation of incubators - interface conditions (Part 1) EN 13976-2:2011 – Rescue Systems: Transportation of incubators - system requirements (Part 2) EN 50527-2-1:2011 – Procedure for the Assessment of the Exposure to Electromagnetic Fields of Workers Bearing Active Implantable Medical Devices: Specific assessment for workers with cardiac pacemakers (Part 2-1)

IEC STANDARDS

• Published January 2011 IEC 60601-2-57:2011 – Medical Electrical Equipment: Particular requirements for basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use (Part 2-57)

• Published February 2011 IEC 60601-2-23:2011 – Medical Electrical Equipment: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment (Part 2-23) IEC 60601-2-45:2011 – Medical Electrical Equipment: Particular requirements for basic safety and essential performance of mammographic X-ray equipment and mammomagraphic stereotactic devices (Part 2-45) IEC 60601-2-49:2011 – Medical Electrical Equipment: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment (Part 2-49) IEC 60731:2011 – Medical Electrical Equipment: Dosimeters with ionization chambers as used in radiotherapy

• Published March 2011 IEC 60601-2-27:2011 – Medical Electrical Equipment: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (Part 2-27)

• Published May 2011 IEC 60601-2-34:2011 – Medical Electrical Equipment: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equip-ment (Part 2-34)

• Published June 2011

o IEC 60601-2-31:2008+A1:2011 – Medical Electrical Equipment: Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power source (Part 2-31)

ISO STANDARDS

• Published December 2010 ISO 20857:2010 – Sterilization of Health Care Products: Dry heat - requirements for the development, validation and routine control of a sterilization process for medical devices

• Published February 2011 ISO 23409:2011 - Male Condoms: Requirements and test methods for condoms made from synthetic materials

• Published March 2011 ISO 11040-2:2011 – Prefilled Syringes: Plunger stoppers for dental local anesthetic cartridges (Part 2) ISO 13926-2:2011 – Pen Systems: Plunger stoppers for pen-injectors for medical use (Part 2) ISO 14534:2011 – Ophthalmic Optics: Contact lenses and contact lens care products - fundamental requirements ISO 80601-2-61:2011 – Medical Electrical Equipment: Particular requirements for basic safety and essential performance of pulse oximeter equipment (Part 2-61)

• Published April 2011 ISO 14155:2011 – Clinical Investigation of Medical Devices for Human Subjects: Good clinical practice ISO 15883-6:2011 – Washer- Disinfectors: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (Part 6)


ISO 80601-2-12:2011 – Medical Electrical Equipment: Particular requirements for basic safety and essential performance of critical care ventilators (Part 2-12)

• Published May 2011 ISO 11979-8:2009/A1:2011 – Ophthalmic Implants: Intraocular lenses fundamental requirements (Part 8 - Amendment 1) ISO 13212:2011 – Ophthalmic Optics: Contact lens care products - guidelines for determination of shelf-life ISO 16974:2011 – Respiratory Protective Devices: Marking and information supplied by the manufacturer ISO 19218-1:2011 – Medical Devices: Hierarchical coding structure for adverse events - event-type codes (Part 1) ISO 23908:2011 – Sharps Injury Protection: Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling - requirements and test methods

• Published June 2011 ISO 7439:2011 – Copper-Bearing Contraceptive Intrauterine Devices: Requirements and tests ISO 11073-10407:2011 – Health Informatics: Personal health device communication; Device specialization - blood pressure monitor ISO 13408-1:2011 – Aseptic Processing of Health Care Products: General requirements (Part 1) ISO 13408-2:2011 – Aseptic Processing of Health Care Products: Filtration (Part 2) ISO 13408-3:2011 – Aseptic Processing of Health Care Products: Lyophilization (Part 3)

ISO 13408-4:2011 – Aseptic Processing of Health Care Products: Clean-in-place technologies (Part 4) ISO 13408-5:2011 – Aseptic Processing of Health Care Products: Sterilization-in-place (Part 5) ISO 13408-6:2011 – Aseptic Processing of Health Care Products: Isolator systems (Part 6) ISO 18308:2011 – Health Informatics: Requirements for an electronic health record architecture ISO 22413:2011 – Transfer Sets for Pharmaceutical Preparations: Requirements and test methods ISO 25424:2011 – Sterilization of Medical Devices: Low temperature steam and formaldehyde - requirements for development, validation and routine control of a sterilization process for medical devices

• Published July 2011 ISO 7711-2:2011 – Dentistry: Rotary diamond instruments - Discs (Part 2) ISO 11990-1:2011 – Lasers and Laser-Related Equipment: Determination of laser resistance of tracheal tubes - tracheal tube shaft (Part 1) ISO 14160:2011 – Sterilization of Health Care Products: Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - requirements for characterization, development, validation and routine control of a sterilization process for medical devices ISO 25841:2011 – Female Condoms: Requirements and test methods

EC COMMISSION GUIDANCE

• Published June 2010 MEDDEV 2.4/1 Rev. 9 – Classification of Medical Devices: Guidelines relating to application directive 93/42/EEC medical devices

• Published December 2010 MEDDEV 2.7/3 – Clinical Investigations: Serious adverse event reporting under directives 90/385/EEC AND 93/42/EEC MEDDEV 2.7/4 – Guidelines on Clinical investigation: A guide for manufacturers and notified bodies

• Published March 2011 Version 1.9 – Manual: Borderline and classification in the community regulatory framework for medical devices

FDA GUIDANCE

• Published February 7, 2011 1734 – Class II Special Controls Guidance Document: Contact cooling system for aesthetic use

• Published March 8, 2011 1636 – Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence

• Published March 23, 2011 1707 – Class II Special Controls Guidance Document: Ovarian adnexal mass assessment score test system

• Published April 13, 2011 1687 – 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes


• Published April 14, 2011 1735 – Class II Special Controls Guidance Document: Low level laser system for aesthetic use

• Published April 25, 2011 1582 – Class II Special Controls Guidance Document: Topical oxygen chamber for extremities

• Published May 17, 2011 1751 – Assembler’s Guide to Diagnostic X-Ray Equipment

• Published July 15, 2011 1638 – Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses

• Published July 20, 2011 1701 – Class II Special Controls Guidance Document: Focused ultrasound stimulator system for aesthetic use

• Published July 21, 2011 1597 – Class II Special Controls Guidance Document: Electrocardiograph electrodes

• Published July 26, 2011 1728 – Class II Special Controls Guidance Document: Repetitive transcranial magnetic stimulation (rTMS) systems

GHTF GUIDANCE

• Published September, 2010 SG4/84:2010 – Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers: Audits of manufacturer control of suppliers (Part 5)

SG4/83:2010 – Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers: Multiple site auditing (Part 4) SG4/N30:2010 – Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers: Regulatory auditing strategy (Part 2)

HEALTH CANADA GUIDANCE

• Published January, 2010 GUI-0059 – Guidance Document for Mandatory Problem Reporting for Medical Devices

• Published March, 2011 GUI-0054 – Guide to Recall of Medical Devices GUI-0065 – Guidance on Investigation of Reported Medical Device Problems

• Published April, 2011 GUI-0016 – Guidance on Medical Device Establishment Licensing and Medical Device Establishment License Fees

• Revised April, 2011 (Adopted June, 2005) How to Complete the Application for a New Medical Device License/Medical Device License Amendment for a Private Label Medical Device

• Revised April, 2011 (Adopted January, 1999) How to Complete the Application for a New Medical Device License

HONG KONG MDCO GUIDANCE

• Published July, 2011 GN-02 – Guidance Notes for Listing Class II/III/IV Medical Devices GN-06 – Guidance Notes for Listing In Vitro Diagnostics (IVD) Medical Devices

TGA

• Published May, 2011 Australian Regulatory Guidelines for Medical Devices (ARGMD)




SGS MEDICAL DEVICES TRAINING COURSES, WEBINARS AND INDUSTRY EVENTS

SEPTEMBER 2011 TO JANUARY 2012PUBLIC TRAINING COURSES

SGS is delivering the following public training courses:

• September 20, 2011: Construction of a MDD Technical File, Heathrow UK

• September 27, 2011: Introduction to IVD Directive 98/79/EC, Birmingham UK

• September 26-27, 2011: ISO 13485 Internal Auditor, Heathrow UK

• September 29-30, 2011: ISO 13485 Internal Auditor, Gurgaon India

• October 17, 2011: Medical Device Regulatory Requirements (JPAL, MDD, CMDCAS), Singapore

• November 14-15, 2011: ISO 14971 Risk Management for IVD Medical Devices, Korea

• November 28, 2011: Introduction to Sterilization, Singapore

FREE WEBINARS

• SGS free global webinars on hot topics in the medical devices industry. After the live broadcast, each is available as a recorded version:

• September 29, 2011: Future of the IVD Market, Recast and New Standards

• October 12, 2011: IEC 60601-1-11, The New Household Device Standard can Significantly Affect Design

• November 16, 2011: The Transition to IEC 60601-1 3rd edition, Timeline and New Requirements

EVENTS

SGS is participating in the following events: http://www.sgs.com/en/Our-Company/Events.aspx

• September 14, 2011: SGS Wireless Lab Open House, San Diego USA

• September 20, 2011: SGS Full Capability E&E Test Lab Open House, Atlanta (Suwanee) USA

• September 20-22, 2011: MD&M Conference and Exhibition - Chicago USA

• October 22-25, 2011: RAPS Conference and Exhibition, Indianapolis USA

• November 1-3, 2011: MD&M Conference and Exhibition, Minneapolis USA

• November 27-December 2, 2011: RSNA Conference and Exhibition, Chicago USA

• January 25-26, 2012: Medical Device Directive and Recast Conference, Brussels Belgium

For more information about the SGS presence in these events, please go to http://www.sgs.com/news_center/sgs_events.htm

For further information on any events, webinars or training courses please contact us at [email protected]

http://www.sgs.com/en/Our-Company/Events.aspx

http://www.sgs.com/news_center/sgs_events.htm

http://www.sgs.com/news_center/sgs_events.htm


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