1. MEDICAL DEVICE POST MARKET SURVEILLANCE AND VIGILANCEInforma Medical Device Post Market Erik VollebregtSurveillance and Vigilance www.axonadvocaten.nl27 February 2013

2. Introduction + agenda Understanding how the roles of the economic operators are expected to be defined in the revision of the MDD Examining new PMS obligations for various operators in the medical devices supply chain as a result of the revision of the MDD How to implement overlapping responsibilities of economic operators in supply and distribution agreements Clarifying autonomous responsibilities of operators in the supply chain of medical devices

3. Economic operatorsThe MAID: Article 2: economic operators means the manufacturer, the authorised representative, the importer and the distributor;Proposal implements strict supply chain control mechanism Blueprint from new new approach decision 768/2008 As implemented in other specific instruments, e.g. toys and falsified medicinal products directive Goal: enlist supply chain in market surveillance by imposing autonomous obligations on the various stages of the supply chain

4. Definition of importerArticle 2 importer means any natural or legal person established within theUnion who places a device from a third country on the Union market;placing on the market means the first making available of a device, otheran investigational device, on the Union market; placing on the market is neutral as to goods and services, online and offline

5. Economic operators: importersMust ensure that:1. the appropriate conformity assessment procedure has been carried out by the manufacturer;2. an authorized representative in accordance with Article 9 has been designated by the manufacturer;3. the EU declaration of conformity and the technical documentation have been drawn up by the manufacturer;4. the device bears the required CE marking of conformity;5. the device is correctly labeled and accompanied by the required instructions for use and EU declaration of conformity;6. a Unique Device Identification has been assigned;

6. Economic operators: importersMust furthermore:1. Be able to identify any economic operator to whom they have supplied a device, any economic operator who has supplied them with a device and any health institution or healthcare professional to whom they have supplied a device for a period of five years;2. Label the device with their contact details;3. Take corrective action (a.o. recalls and report to authorities) autonomously;4. Engage in post-market surveillance (among other things report complaints); and5. Refuse to import devices of which he has reason to believe are not in conformity with the requirements.

7. Definition of distributorArticle 2 distributor means any natural or legal person in the supply chain,other than the manufacturer or the importer, who makes a device availableon the market any natural or legal person in the supply chain Includes resellers, rental companies whether online or offline makes a device available on the market any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge

8. Economic operators: distributorsMust verify that:1. the product bears the required CE marking of conformity;2. the product is accompanied by the information to be supplied by the manufacturer;3. the manufacturer and, where applicable, the importer have complied UDI and importer labeling requirements

9. Economic operators: distributorsMust furthermore:1. ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements;2. Label the device with their contact details;3. Take corrective action (among other things undertake recalls and report to authorities) autonomously;4. Engage in post-market surveillance and vigilance (i.e., report complaints)

10. With such supply chain duties, dowe still need authorised reps?Yes, AR must at least:1. keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate including any supplement issued at the disposal of competent authorities for the applicable period;2. in response to a reasoned request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device;Notably only AR is allowed and required to terminate the mandate if themanufacturer acts contrary to his obligations under this Regulation.

11. Criticism on supply chain regsCOCIR: several of the described tasks overlap and thus add unnecessary administrative burden with no obvious benefit for the patients. COCIR suggests that the importer obligations should only apply in situations where there is no organisational or legal relation (contract) between the manufacturer and the importer and the manufacturer has appointed an Authorised Representative in the EU. Eucomed:It is absolutely essential that the overlapping obligations and responsibilities ofdifferent economic operators be clarified in the areas of device registration, vigilancereporting and market surveillance. The definition of clear roles and responsibilities foreconomic operators is not only critical to the functioning of the system, it is critical tothe way the supply chain to hospitals and patients work. If not done correctly, it couldhave catastrophic effects on certain operators and SMEs within the supply chain,effectively closing their businesses overnight and risking unavailability or increasedcosts to hospitals and patients.

12. Dealing with overlappingresponsibilities in supply chain regulatory compliance upstream If importer/distributor considers or has reason to believe that a device is not in conformity, he shall not make the device available on the market until it has been brought into conformity. Importer must do sample checks if appropriate regarding to risk autonomous post-market surveillance obligations If reason to believe that a device is not in conformity: immediately inform the manufacturer and make sure that the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken immediately forward to manufacturer complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available)

13. Post Market SurveillanceProvisions in Article 8 (6) Manufacturer must have and implement post market surveillance plan Chapter VI of new MDR (Clinical evaluation and clinical investigations) Article 49: Manufacturers shall conduct a clinical evaluation in accordance with the principles set out in this Article and Part A of Annex XIII Annex XIII pre-market clinical evaluation and post-market clinical follow- up Part A (pre) Clinical evaluation Part B Post Market Clinical Follow Up - includes PMCF plan

14. Post Market Surveillance Article 8 (6): The post-market surveillance plan shall set out the process for collecting, recording and investigating complaints and reports from healthcare professionals, patients or users on suspected incidents related to a device, keeping a register of non-conforming products and product recalls or withdrawals, and if deemed appropriate due to the nature of the device, sample testing of marketed devices. Part of the post-market surveillance plan shall be a plan for post-market clinical follow-up in accordance with Part B of Annex XIII. Where post-market clinical follow- up is not deemed necessary, this shall be duly justified and documented in the post-market surveillance plan. Process must be implemented in supply chain

15. Post Market SurveillancePost Market Surveillance as we know it will be pro-actively laid down in themanufacturers post market surveillance plan (Annex XIII part B): Post-market clinical follow-up, hereinafter: PMCF, is a continuous process to update the clinical evaluation referred to in Article 49 and Part A of this Annex and shall be part of the manufacturers post-market surveillance plan. To this end, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which is authorised to bear the CE marking, within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety and performance throughout the expected lifetime of the device, the continued acceptability of identified risks and to detect emerging risks on the basis of factual evidence.

16. Implementation of PMS in supplychainIn addition to the usual provisions account for autonomous obligations onthe part of importers and distributors: implement mechanism for importer / distributor to check upstream compliance and consequences on both sides ensure that manufacturer is always informed of autonomous action undertaken preferably consulted (implement RACI for autonomous obligations) account for consequences of autonomous action manufacturers reputation is on the line autonomous action impacts entire supply chain ensure appropriate liability and indemnities

17. Example clause that needs changing

18. So is this the final word? Looks like it method chosen for supply chain is the Decision 768/2008 system (articles R4 and R5) which has already been implemented in CE directives (e.g. toys) so fully new new approach compliant Powerful arguments necessary to convince Commission to depart from system

19. Thanks for your attentionErik VollebregtAxon LawyersPiet Heinkade 1831019 HC AmsterdamT +31 88 650 6500F +31 88 650 6555M +31 6 47 180 683E erik.vollebregt@axonlawyers.com@meddevlegal READ MY BLOG:B http://medicaldeviceslegal.com http://medicaldeviceslegal.com