Transitioning from MDD to MDR — Part 1
MDD (Medical device directive) which was regulation for medical devices then in some EU countries is now getting replaced with new regulation called MDR (Medical Device Regulation) MDR is designed to be an improved version and one of the important facts is that it influences and effective in all 27 member EU states including UK. Legal base of regulation will shift to EU and not like MDD where individual country was involved.
One of the important steps is that even current companies with their products already in the market are also going to be influenced by new regulation and they must ensure their existing product comply to MDR. This will help overall improvement in the field of medical device. Making some empirical comparison; MDR is four times bigger document than MDD. The word safety appears 290 times as compared to 40 times in MDD. This itself explains the impact. Nothing is removed from MDD but lots of additions have been made in MDR. All additions are new to improve safety in medical device.
Why Changes? MDD came into existence in 1992. Software now used in medical device or software’s as medical device were not available then. Average age of person has also risen since 1992. This brought lot of challenges to medical device field where self- regulated medical device came into existence using software.
With final Validity now over on May 26, 2021, all old MDD and AMDD certificates will be valid till May 26, 2024, in the same limited area defined in old certificates. They all will be void on May 27, 2024 so if transition of those does not happen to new requirement as per MDR, they all will be out of business. You can continue to market all your old product, but no change will be allowed even as per MDD/AMDD.
MDR does not advocate grandfather legacy products so very limited allowance is available for short term continuance of existing product.
Let us now know the key area where work need to be done fast as area and scope in MDR as specified above is very wide. It is advisable that MDR consultant should be hired to expedite transition without flaw and faster. We at IZiel offer this service with very competent team who can look at your products and work accordingly by creating a plan, gap assessment and work throughout till your migration.
EU Preparedness for Transition: Designated notified bodies across EU were planned as 20. As per present status 18 are established as of Feb 11, 2021.
Notified Body Audits: In view of prevailing Covid 19 situation, notified bodies decided to do offsite audits using published guidelines issued by International Accreditation Forum (IAF) like how to use communication technologies and alternative auditing methods in emergency. Existing manufacturer thus should be ready with whatever directive notified may issue.
After having done for existing product, it is extremely important to plan for migration from MDD to MDR.
It is not only just revising technical documentation but would need massive work on revising and creating lot of SOPs and change in QMS, Specifically Risk management and Post Market expectation. Next step will be first planning which is to prepare GAP assessment based on that manufacturer can allocate and decide resource requirement. Lot of definitions are changed in MDR for clinical data and clinical evaluation and Investigation, equivalence, these will necessitate QMS change, technical documentation, and risk assessment documentation also.
Major changes: Like preapproval in MDD to lifecycle approach in MDR which is normally used by US FDA.
More Stress on clinical trial data and clinical evaluation specifically on equivalence interpretation.
Notified bodies competency will be re-examined in view of new requirement and strictness on them will also increase.
Clinical investigation for implantable class III devices: Notified bodies will seek high quality clinical investigation and compelling clinical evidence.
More transparent review frame by regulatory body. Most companies will have to update clinical data, technical documentation, and labeling. UDI (Unique Device Identification) to track device throughout economic operator and supply chain. UDI number will come on all labels. No Medical purpose was necessary in MDD, but it is required in MDR.
Definition of Medical device is expanded to include non-medical products like, products for cleaning, disinfection, and sterilization.
Centralized reporting of all incidents on EU portal for injury, death. Non serious incidence reporting time is now increased from 15 days to 30 days.
Many devices will go under reclassification to high-risk class also. E.g., new classification for re-usable surgical devices and requiring notified body oversight. Many devices will become class III so automatically will have more compliance requirement.
Manufacturer will have to appoint one regulatory person who will ensure regulatory compliance and see that all new regulations are followed. This will be like Qualified Person (QP) in pharmaceutical industry.
Apart from manufacturer notified bodies will also have more responsibilities for testing and assessment.
Though all those regulations are brought for patients and users, and they will feel safe but will also feel strict restrictions to get products which used to be easier earlier.
In our next Blog we will discuss how consultant, like we at Iziel can help you, which area and how, with a suggested approach by asking you relevant questions.
