MDR vs. MDD: 13 Key Changes
All Those involved in medical device field must be thorough with MDD (Medical device directive) and now familiar and knowledgeable with new regulation by EU MDR (Medical device regulations) Like MDR was made to replace MDD and then it was applicable to EU and UK, however situation changed for UK after BREXIT. We will restrict our blog to MDD Vs. MDR and what major changes are there which manufacturer or distributor must take care if they need to continue business in EU countries. (With Brexit even business with UK will also be possible if MDR is followed if certain aspects are taken care for administrative purpose)
Though one can say that MDR is not radically different from MDR but lot of changes have happened in MDD clauses and all manufacturers will have to do work for those as this is now effective after May 5, 2021. Though MDR has become effective, those who already have MDD can take advantage of various extensions extended and latest extension for certain device comes as late as 27th May 2025.
Administrative hassles, and creation of notified bodies and Covid 19 pandemic caused lot of delay.
Timeline:
Certificate issued under MDD becomes void if not expired, means last date for placing device in market as per MDD is 26th May 2024. Last date for putting device into service as per MDD is 26th May 2025. If your certificate is expired in 2020 or 2021, MDR is an advisable answer.
There are no devices grandfathered in MDR. So, all the manufacturer who were under grand fathered status under MDD need to transit to MDR now itself.
Even though, as suggested above you can continue to market as late as 26th May 2025, there are lot of restrictions.
1. No substantial design changes are acceptable to notified bodies.
2. Device must remain in compliance to the state-of-the-art requirement, including EU issued common specification and recognized standards.
3. PMS (Post market surveillance) requirement must be implemented along with PMCF (Post market clinical follow up) or justification is required why no PMCF.
4. Registration requirement for all economic operators need completion. Manufacturer must ensure that quality agreement is in place for Authorized representative, importer, and distributor.
In above situation it is advisable to hire MDD to MDR consultants for gap assessment and transition preparation. These consultants can take up CER reviews as well as training also. Certain aspects of future job can be accomplished through MDR consultants also as interpretation of various clauses of MDR need an expert and experienced eye.
1. MDD vs. MDR: Let us understand some verbatim changes so significance can be understood, and detailing can be worked out.
2. MDR is almost four times larger than MDD.
3. The word “Safety” appears 240 times against only forty times in MDD. This signifies stress and approach and required technical documentation changes.
4. Stress on conducting global impact assessment and to remain in compliance thereafter.
5. New safety and performance requirements which identifies new condition need to be addressed. (Like, CE mark under MDD and product re-certification)
6. UDI implementation.
7. MDD scope did not encompass medical purpose of medical device and AIMDD, both are part of MDR.
8. Definition of medical device is broadened to include non-medical and cosmetic devices which were not previously in scope of regulation. (Ex, contact lens, liposuction equipment)
9. More in depth clinical data and evaluation.
10. Reporting of all incidents, serious incidents including death now needs reporting in EU portal as centralized data for better access for patient. Non serious incident reporting time reduced from 30 days to 15 days.
11. Companies undergoing transitions shall have to pay more attention on core processes of QA, risk management and post market expectations. These all must be aligned to new requirement.
12. Reclassification of many medical devices will be required to higher risk class. New classification for reusable surgical devices will require notified body oversight. (Notified body come in picture)
13. IVD are classified now into four risk classes. 90 % of them will now come under purview of notified bodies as against earlier only 10 %.
MDR is effective now but certain medical devices compliant with MDD/AIMDD can continue till 26th May 2024 provided there is no significant change in device and intended purpose.
Looking at above 13 changes and maintain the timeline and continuity of business, MDD to MDR consultant or MDR consultant support is advisable.
Our “ONE-STOP COMPLETE SOLUTION” include –
· Gap Assessment
· Technical File Preparation
· QMS Documentation
· Expert Review & Recommendations
· European Authorized Representative (EC REP)
· EUDAMED
· Mock Audits & Trainings
· PRRC Services
· Clinical Evaluation Plan & Report
· Software Validation
IZiel team of specialists and quality professionals look forward to support more medical device companies to file their devices under the MDR 2017/745.
