Today marks yet another milestone in the EU-MDR development: the day on which the EU-MDR and EU-IVDR are being published, with 20 days to go until the day of entry into force, and a total of 1116 days for the date of application of the MDR and 1847 days for the IVDR. Their publication numbers EU 2017/745 for MDR and EU 2017/746 for IVDR will be the most used acronyms in Medtech in the coming years.
Those timelines might seem like plenty of time to get all things in place. But reality will determine that it will be a very tight schedule indeed. Especially if you take into consideration that in the final stages of implementation it would be best practice to have a round of internal audits, followed by a management review, all prior to the notified body inspection. Furthermore, time should be allowed for corrective actions after the notified body audit. Secondly, time will be needed as well for notified body review, including corrective action time; and it is evident that the notified bodies cannot simply review all dossiers of their clients in the last 6 or 12 months of the transition period. Hence it will be key to align the project timing to that of the respective notified bodies one works with.
Key issues in the MDR include the stricter requirements on providing ‘sufficient’ clinical data, and linked with the concept of only strongly reduced allowances on the use of equivalent data in the submission, this aspect is a serious threat to the re-certification of many me-too products.
Key point in the IVDR is the shift towards GHTF classification, so a risk-based rule system, rather than the classical listings of list A and list B. Consequently, the vast majority of IVD products will need a first time notified body assessment.
Both for MDR and IVDR, other key changes include the stronger involvement, and regulatory responsibility and liability of the distribution chain, mainly importer and authorized representative, and to some extent the distributors. Next to that, the enhanced traceability requirements (UDI-focused) and the increased transparency, i.e. summary reports on risk management, on clinical data, and periodic safety update reporting in the publicly available EUDAMED database will provide big resourcing challenges, both initially and continuously.
The above issues should to some extent see its implementation started right away, and for must-get-MDR-certified products, generation additional clinical and performance data on the actual product might even have to start before gap assessments and portfolio assessments are fully completed. No time to waste, with the clock ticking.
As the implementation continues throughout the transition period, the publication of additional pieces of legislation are foreseen, by means of delegated and implementing acts. These acts might fine-tune basically all elements of the MDR and IVDR. The publication of the first set, including details on notified body designation, EUDAMED and UDI is expected before the end of the year.
With 56 notified bodies in MDD (overlapping with the 13 in AIMDD) and 22 in IVD, the big debate has started which notified bodies might get audited for their designation first, as authority resources are limited, and no system is yet defined on order of designation, or aligning the times of designation in such a way that all get a fair chance. On top of that, the diminishing number of notified bodies, in contrast to the expected increase in notified body work, has inspired several companies to start preparing for their first notified body designation.
Fortunately, some escape clauses have been built in, recognizing the time constraint of designating notified bodies, allowing them some more time to finish the reviews and audits. In first instance there is the soft transitioning of an additional 2 years in IVDR and 4 years in MDR for products certified under the existing directives, with specific restrictions and requirements, among others for the notified body to continue surveillance on the certificate, where elements of the MDR such as PMS and vigilance will need to be adhered to. Also no significant changes can be allowed to the products, as the notified bodies will not be allowed to make alterations on the certificates. As this clause relates to valid directive certificates, this extension will not be available to class I manufacturers, nor to most of the IVD products that are currently under self-certification. (blog: ‘entering the twilight zone’)
The last escape is the ‘sell of stock’ option, where products produced before the date of application (2020 resp. 2022) may continue to be sold. This option is available to all products.
Should you not yet have completed your gap assessment, a portfolio assessment and rationalization, it is now really the time to start. Next, also first budgets for the implementation phase need to be brought in place.
Time is now also to finalize classification reviews, to finalize rationales on clinical data requirements and their exceptions, on re-certification strategies and on decisions with which notified bodies one continues. To replace suppliers that are unwilling or unable to follow into the transparent new regime and to shift notified body in case you have reason to believe they might not timely support you into the new regulations.
Should you wish to discuss your program and the regulatory details with your peers, then please join our modular interactive workshop based EU MDR program.
Should you wish to compare the status of where you are, then please try out our new compliance status app (available the 15th of May). The underlying database will be regularly refreshed, so on given moments you can re-tune your status.
Should you have any other demand, then feel free to contact me. Always happy to discuss some details!
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