1. New European Medical Device Regulations – major changes that will affect all devices
Rene van de Zande
EMERGO | President & CEO
March 31, 2016

2. New European Medical Device Legislation – Two Drafts: MDR (12040/15) and IVDR (12042/15)
Trigger: PIP scandal in 2010
Post-market safety issues
Weak oversight of Notified Bodies
Lack of market surveillance by Competent Authorities
Lack of transparency and traceability
Access to external expertise
Management of the EU regulatory system

3. Important proposed changes
General management of medical devices in Europe (Medical Device Coordination Group)
Pre-market Approval?
New or changed definitions – up-classification, non-medical devices
Traceability and registration of devices
Central database for devices
Introduction of UDI
Introduction of economic operators
Introduction of a Qualified Person
More defined role of Notified Bodies (unannounced visits)
Extra requirements for clinical evaluations / clinical investigations
Post-market surveillance and vigilance procedure much more detailed

4. Traceability of medical devices
Traceability, registration and publication of information concerning medical devices placed on the European market
Central database for devices – EUDAMED
A summary of safety and clinical performance statement made publicly available for Class III and implantable devices (art. 26)
A periodic safety report must be updated annually for every device or group of devices during the life time of the device (art. 60)
Accessible by Competent Authorities, Notified Bodies…and by manufacturers, health care professionals, end users and the general public (?)
“Appropriate” level of traceability - responsibilities for each in the supply chain

5. Unique Device Identification - UDI
EU COMM Recommendation 2013/172/EU
Device identifier placed on the label by manufacturer
Stored electronically by economic operators and health institutions
EU COM and member states shall operate the system
Considerable International activity (IMDRF)
United States currently ahead of EU

6. Qualified Person
Qualifications: expert knowledge in the field of in vitro diagnostic or medical devices
Three years of professional experience in regulatory affairs or in QMS relating to medical devices or IVD’s
Responsible for ensuring: that the conformity of the devices is appropriately assessed
Technical documentation and the declaration of conformity are drawn up and kept up-to-date
Vigilance requirements have been fulfilled
Authorized representatives also required to have person responsible for regulatory compliance

7. European Authorized Representative
Article 9.(4a) provides that where the manufacturer is not based in an EU Member State, the authorized representative “shall be legally liable for defective devices…”
Possibly in conflict with other European legislation including the Product Liability Directive
Arguments could be made that this could lower patient protection

8. Already here… Unannounced audits
More attention by Notified Bodies into PMS
Faster communication between competent authorities in case of vigilance cases or suspected non-compliances
More pressure on Notified Bodies to take an active role in preventing non-compliant devices to be placed on the market

9. Increased scrutiny of and by Notified Bodies
EU COMM Implementing Regulation (920/2013) designation supervision Notified Bodies
Expect that over half of the current 70 NBs will not be re- notified or may not be notified for the same scope
Selection of NBs: Expertise and Competence, Size, Signed Code of Conduct, Which Member State notified the entity, Availability

10. Unannounced Notified Body audits
EU COMM Recommendation for notified bodies’ unannounced visits (2013/473/EU)
Be ready for unannounced inspections…

11. Unannounced NB audits
Minimum every 3 years (more frequently for high-risk)
Verify that manufacturing in line with documentation
Audit at least two critical process:
Design control, purchasing, incoming materials, assembling, sterilization, packaging product QC
Design Examination/Type Examination sample several products at end of line or warehouse
Test in-house or in external labs
Sampling and test criteria determined in advance
If impossible to take samples from market, where needed supported by competent authority
Compare with existing technical documentation, test protocols and results

12. How to handle unannounced audits
SOP for unannounced notified body audit
Train staff about unannounced notified body audits
Familiar with notified body contract and agreement about critical subcontractors and crucial suppliers
Keep notified body informed on production schedule
Review contracts with critical subcontractors and crucial suppliers
Unannounced audit of critical subcontractors and crucial suppliers

13. IVDR
Risk-based classification system for IVDs based on GHTF recommendations
Greater requirements on IVDs that are now self-certified
Transition period of 5 years is currently considered, so manufacturers should have time to adjust to changes

14. New classification for IVDs

15. Majority of IVDs will require NB intervention
Future IVD Regulation
IVDD 98/79/EC
Require notified body
Do not require notified body
80-90%
Require
notified
body
Do not require notified body

16. MDR and IVDR - timelines
October 2012 Commission proposal
April 2014 Parliament proposal
June 2014 Commission position
June 2015 Council general approach
September 2015 Council draft
Next step: negotiation between Council and Parliament (and Commission) “trilogues”
Currently, still in First Reading
Dutch Minister of Health (January –June 2016), wants to have final version for second reading by June 2016

17. Main impact of this future legislation
Innovative, high risk devices delayed market entry
Cost increase industry (MDCG review, unannounced visits, traceability system review, UDI, implant card)
Highly qualified staff required for manufacturer, notified body (and AR)
NB assessment team: At least one expert in technology
Documentation, review technical file, Summary of Safety and Clinical Performance, Essential Requirements text change for General Prescription for Safety and Efficiency

18. Finding and Evaluating Medical Device Distributors in Europe
Don’t forget…
Europe has a harmonized approval process but it is not a unified market for business
Vastly different cultures, 24 primary languages
28 member states - 19 use the Euro
Norway, Iceland, Liechtenstein, and Switzerland members of the EEA
500+ million people!
Regulations should not stop you to market your devices in Europe!
Europe is a very attractive market, but also very challenging. U.S. products are well respected and innovative products are in high demand. The exchange rate is also in favor of U.S. manufacturers. With almost 500 million people, it is 50% larger than the United States and there are almost twice as many people over age 65 in Europe as in the U.S.
Map:
Dark blue - 15 original EU countries
Yellow - central European countries that joined in 2004, with Poland, Hungary, and Czech Republic as the largest markets
Light blue – Romania and Bulgaria joined in 2007; Turkey has applied
Note: all of Europe is less than half the size of the USA

19. Questions? Daryl Wisdahl Rene van de Zande VANCOUVER AREA
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Suite 205
Surrey, BC, V4N 0W7
Canada
TORONTO AREA
10 Four Seasons Place, Suite 1000
Toronto, ON, M9B 6H7
Canada
Daryl Wisdahl
Managing Director, Canada
Rene van de Zande
President and CEO
Global Medical Device Consulting