mdr workshop exercises - qserve® group mdr... · a global leading medical device consultancy group...
TRANSCRIPT
A global leading medical device consultancy group
MDR – Workshop Exercises
Gert BosExecutive Director & Partner
Page 2 | Copyright Qserve Group B.V.
Assignment 1 - classification
• Individually consider classifications for the adjacent products; identify all applicable classification rules:
• Next, compare in groups
• Then, group discussion
1. ECG machine
2. AED automated defibrillator
3. Pacemaker
4. Vascular stent for lower leg
5. Orthopedic spinal implant with screws
6. Orthopedic reusable instruments
7. Plaster with healing ointment
8. Oxygen Saturation device for finger
9. Non-correcting tiger eye contact lenses
10. Software to measure and trend heartrate on smartphone
Page 3 | Copyright Qserve Group B.V.
Assignment 2 – conformity assessment route
• Individually consider the allowed conformity assessment routes for the adjacent products:
• Next, compare in groups
• Then, group discussion on best options
1. ECG machine
2. AED automated defibrillator
3. Pacemaker
4. Vascular stent for lower leg
5. Orthopedic spinal implant with screws
6. Orthopedic reusable instruments
7. Plaster with healing ointment
8. Oxygen Saturation device for finger
9. Non-correcting tiger eye contact lenses
10. Software to measure and trend heartrate on smartphone
Page 4 | Copyright Qserve Group B.V.
Exercise 3 - labeling
• Changes to label and IFU include product name, formal clinical claims, intended use, name and address of manufacturer/ importer/EAR, symbols, batch information, UDI, etc.
• Which organization units will need to provide input?
• Who will be in the lead?
• Who will have final control?
• What is the impact?
• Discussion in small group, then group discussion
Page 5 | Copyright Qserve Group B.V.
Exercise 4 – downstream supply chain
• For EAR, importer and distributor, identify what needs to be put in:• Contract / quality agreement
• Subcontractor approval system
• Anywhere else
• Discussion in groups
• Group discussion
Page 6 | Copyright Qserve Group B.V.
Exercise 5 – upstream supply chain
• For critical subcontractors and crucial suppliers, identify what needs to be put in:• Contract / quality agreement
• Subcontractor approval system
• Anywhere else
• Discussion in groups
• Group discussion
Page 7 | Copyright Qserve Group B.V.
Exercise 6 – Periodic Update Reporting
• Discuss in groups what information can be generated from current processes and monitoring
• What else might be needed?
• How to collect information?
• How to structure data; order of topics in report template
• How to get this organized?
• Present plans to whole group
Page 8 | Copyright Qserve Group B.V.
Exercise 7 – Vigilance
• What is needed to meet the 15 day reporting timelines?
• What needs to be in QA agreements?
• Discussion in groups
• Group discussion
Page 9 | Copyright Qserve Group B.V.
Exercise 8
iMAGINEMEDICAL
Page 10 | Copyright Qserve Group B.V.
iMAGINEMEDICAL
Page 11 | Copyright Qserve Group B.V.
Virtual Company - description
• iMAGINE
• Organization focused on marketing and sales• Size: 110 fte
• Headquarters: China
• Production locations: ‒ Shanghai
‒ Seattle US
• Sales offices: ‒ Amsterdam
‒ Japan
Page 12 | Copyright Qserve Group B.V.
iMAGINE – Notified Bodies
• IMAGINE uses 2 NB’s:
1. Bono; ‒ All services & scopes.
‒ Local offices.
‒ Front runner on Clinical reviews, very focused on rev4.
2. Nobi; ‒ Reduced Scope since 2016 (IVD removed from scope).
‒ Local offices.
‒ Moderate focus on Clinical reviews, the reviews have been weak in the past, they are trying to catch up, NB reviewers have yet to be trained on rev 4.
Page 13 | Copyright Qserve Group B.V.
Product lines
Three device families:• TENS
‒ management of chronic lower back pain
‒ China and Japan are main markets
• WOCA ‒ wounddressing
• IVCA‒ Intra vascular catheter
‒ +/- antimicrobial coating
‒ Coating appears to be nanomaterial
Page 14 | Copyright Qserve Group B.V.
iMAGINE- product portfolio
• TENS device (TENS)
• Wound dressing (WOCA)
• IV catheter family>> product innovation will add nanomaterial coating to prevent microbial overgrowth (IVCA-/+)
• Option to extend portfolio with bioresorbable vascular scaffold (forcoronary artery stenosis) (SCAFF)
Page 15 | Copyright Qserve Group B.V.
iMAGINE- product portfolio
• TENS: Transcutaneous Electrical Nerve Stimulation
• Class IIa: active therapeutic device (rule 9)
• Intended Use: For the treatment and relief of chronic lower back pain
• CER available (MEDDEV 2.7.1/rev 3)
• Three systematic reviews were reported (see next page)
• Different results on clinical performance
• Equivalent devices appear to use similar protocols of TENS
Page 16 | Copyright Qserve Group B.V.
TENS clinical trials systematic
reviews
Author 1, 2015 Author 2, 2007 Author 3, 2016
Intended use/ Indication Chronic lower back pain Chronic musculoskeletal pain Chronic low back pain
Control Sham TENS Non active placebo (e.g. sham TENS
or PENS, placebo analgesic)
Only before/after effect. Control
groups in RCTs were ignored.
Date of search July 19th 2014 November 2006 Marc 2015
# Studies considered/included 45 potentially relevant/4 included 134 papers reviewed/ 29 papers, 38
studies included
303 initial hits, 71 papers/79
studies reviewed, 12 studies
included
# patients 585 in RCT 474 PENS/ TENS, 335 placebo, 418
cross-over
267 treated patients
Analysis Qualitative synthesis Meta-analysis Meta-analysis
Adverse effects minor skin irritation at the site of electrode
placement. One patient developed a rash.
No data reported No data reported
Conclusion Conflicting evidence on pain reduction. No
improvement of back-specific functional
status.
Both PENS and TENS are effective in
pain reduction on chronic
musculoskeletal pain.
TENS demonstrated significant
pain reduction.
Page 17 | Copyright Qserve Group B.V.
iMAGINE- product portfolio
• WOCA: Wound dressing, gauze with ointment that stimulates healing by secondary intent
• Class IIb
• CER following MEDDEV 2.7.1/rev 3, signed of by clinical expert fromclinical institution in the US
• Product CE certificate from BONO NB
Page 18 | Copyright Qserve Group B.V.
iMAGINE- product portfolio
• IVCA: Peripheral vascular catheter
• Class IIb, CE marked under MDD Annex II QS certificate from NOBI
• Based on customer feedback IVCA is produced in two variants: +/- anti microbial coating
• Anti microbial agents have been incorporated into a number of medical devices including dressings, central venous catheters and urinary Foley catheters
• iMAGINE has selected a silver nano particle as the anti-microbial agent
• Both IVCA- and IVCA+ are covered by the same CER
• CER was never reviewed by NOBI, and written by the product manager for this product
Page 19 | Copyright Qserve Group B.V.
iMAGINE- product portfolio
IVCA + Coating under the new MDR
6.7. Rule 19
All devices incorporating or consisting of nanomaterial are:
in class III if they present a high or medium potential for internal exposure; in class lIb if they present a low potential for internal exposure; in class Ila if they present a negligible potential for internal exposure.
Page 20 | Copyright Qserve Group B.V.
Possible addition to portfolio
SCAFF
• Bioresorbable vascular scaffold with medicinal to treat coronarystenosis (Class III)
• Developed by start-up company
• Clinical strategy reviewed by BONO and deemed appropriate
• Preclinical- and verification testing assessed by iMAGINE- no issues identified
Pending:
• Clinical trial needs to be completed before CE (not started yet)
• Randomized controlled trial, 2-arms, 200 patients in total)
Page 21 | Copyright Qserve Group B.V.
SCAFF: clinical development
Page 22 | Copyright Qserve Group B.V.
iMAGINE – Clinical data
• The product families have the following clinical documentation:
Product Family CER Manufacturer own Clinical
Data?
Remarks
TENS Rev3 Yes PMCF study in China (Shanghai) recently completed total 50
patients, local CRO, is ongoing
WOCA Rev3 No Based on equivalence
IVCA (+/-) No No Manufacturer: Justification based on literature : IV catheters are
used for over 30 years. Product performance standards sufficiently
control all risks.
SCAFF Not yet
(Clinical strategy
document only)
No Excellent preclinical profile.
CER has identified the need for clinical investigation. RCT 2 arms with
200 patients in total with 2 years of follow-up.
Page 23 | Copyright Qserve Group B.V.
Clinical workshop today:
1. Review medical current clinical evidence and develop a plan to demonstrate compliance under the MDR (apply MEDDEV 2.7.1/rev 4)
2. Identify possible compliance gaps in QMS
3. Should iMAGINE extend their product portfolio with the SCAFF product?
Page 24 | Copyright Qserve Group B.V.
Impact assessment
1. Review medical device portfolio and current clinical evidence• Scoping of the CER: what are the claims and risks, is there sufficient clinical evidence
• Use of equivalent devices from other manufacturer?
• Have all the requirements for safety and performance been met?
• Clinical trials needed?
• Estimated the buget?
Page 25 | Copyright Qserve Group B.V.
What aspects of the Clinical Evaluation need to be improved, how?
# Subject: TENS WOCA IVCA SCAFF
1Scope of the CER
2Equivalent devices
3Sufficient clinical data
4All claims addressed
5All risks addressed
6
Conformity with the relevant
safety and performance
requirements (ER)
7
Page 26 | Copyright Qserve Group B.V.
What devices are in need of clinical investigation, what should be the objective of the clinical trial?
DEVICE NAME:
Clinical investigation:
(yes/no, please explain)
Clinical trial objective(s):
Estimate clinical trial
budget:
Page 27 | Copyright Qserve Group B.V.
iMAGINE – Clinical data
• The product families have the following clinical documentation:
Product Family CER Manufacturer own Clinical
Data?
Remarks
TENS Rev3 Yes PMCF study in China (Shanghai) recently completed total 50
patients, local CRO, is ongoing
WOCA Rev3 No Based on equivalence
IVCA (+/-) No No Manufacturer: Justification based on literature : IV catheters are
used for over 30 years. Product performance standards sufficiently
control all risks.
SCAFF Not yet
(Clinical strategy
document only)
No Excellent preclinical profile.
CER has identified the need for clinical investigation. RCT 2 arms with
200 patients in total with 2 years of follow-up.
Page 28 | Copyright Qserve Group B.V.
iMAGINE- overviewProduct
Family
name ClassNotified
BodyQMS, scope Description
Is there Clinically Sufficient
evidence?Actions?
TENS TENS IIa BONO
ISO 13485:2016,
valid 18-06-2018
Scope: production,
distribution and selling of
medical devices for the
treatment of chronic pain.
Transcutaneous
electrical nerve
stimulation.
For the treatment
and relief of chronic
lower back pain
No, conflicting results.
Control (sham) sometimes
missing. Indications differ.
Objectivity?
.
WOCA WOCA IIb BONO
ISO 13485:2016,
valid 26-12-2020
Scope: production,
distribution, and selling of
medical devices for wound
care.
Wound dressing:
Gauze with ointment
that stimulates
healing by
secondary intent
Yes, but no documented yet
in accordance with rev 4.
IVCA IVCA II b/III NOBi
ISO 13485:2012,
valid 15-07-2017.
Scope: design, production,
distribution and selling of
medical devices.
Periheral
Intravascular
catheter for
administration of
medication/
sampling of blood
IVCA +/-
antimicrobial coating
IVCA-: probably yes
IVCA+: no
Page 29 | Copyright Qserve Group B.V.
Impact assessment:
2. Identify key compliance gaps in QMS:• Clinical Evaluation, PMCF, and PSUR processes (what are the REQS?)
• HR process (competencies, qualifications)
• Supplier management
• Product Labeling and Marketing material
• Other (regulatory submissions process)
Page 30 | Copyright Qserve Group B.V.
How to address Clinical requirements in the QMS?What processes need to be added
PMCFClinicalEvaluation
PeriodicSafety
updates
Page 31 | Copyright Qserve Group B.V.
Portfolio under the MDR
3. Should iMAGINE extend their product portfolio with the SCAFF product?
Page 32 | Copyright Qserve Group B.V.
What should IMAGINE’s portfolio look like under the MDR?
DEVICE NAME:
Intended use:
Decision:
Remark:
Page 33 | Copyright Qserve Group B.V.
Create awareness and urgency for Management Board
• Approval for Clinical Planning based on your gap analysis
• Time critical elements: • Upgrading of CERs under MEDDEV2.7.1/rev 4 and MDR
• Clinical trials
• Notified Body Clinical strategy reviews/ assessments
• Allocate Resources• Resources/ project organization
• Portfolio
• Investments
• Planning of activities
Page 34 | Copyright Qserve Group B.V.
Overall planning CER compliance under MDR:
GAPImplement time-
critical elements
Implement full
plan
Verification
Finetuning
Improvement
Page 35 | Copyright Qserve Group B.V.
Exercise 9 – Transition Plan Details
5 groups• Supply chain
• QMS
• Pre-market
• Clinical
• Post market
• Describe key changes to be implemented
• Indicate stakeholders to be involved
• Present back to group in 5 minutes