Will there be an extra time in the MDR knock-out competition?
Reading the posts in LinkedIn it looks like EUDAMED will be delayed. Some rumors are also spread that up-classified class I devices may get a transition time until 2024. Unfortunately there are no official statements from the authorities yet. Therefore please don’t trust in rumors and don’t delay your implementation activities! Please be cautious and don’t believe something until you really read official statements.
If EUDAMED is delayed, you must read article 123.3(d) of (EU) 2017/745 MDR. You’ll notice that the delay is not a disaster as the consequences were pre-planned in MDR already. Delay of Eudamed will trigger a delay of some obligations. This includes EUDAMED registration of devices (article 29), economic operators (article 31) and SSCP (article 32). To be clear, it wouldn’t be really bad for industry if these obligations would be delayed.
It is also important to understand, that most other requirements will NOT be delayed, like UDI (article 27) and the key elements of the scrutiny procedure (article 54 and 55). Although the submission of PSUR to notified bodies would be impacted, manufacturers would still have to prepare the PSUR and PMS reports (article 86). These activities, especially getting ready for UDI, are time consuming and technically difficult. Therefore don’t stop your activities!
The following section taken from article 123 is essential: “Until Eudamed is fully functional, the corresponding provisions of Directives 90/385/EEC and 93/42/EEC shall continue to apply for the purpose of meeting the obligations laid down in the provisions listed in the first paragraph of this point regarding exchange of information including, and in particular, information regarding vigilance reporting, clinical investigations, registration of devices and economic operators, and certificate notifications.”
If up-classified devices (like software being up-classified from class I to class II or reusable surgical instruments being up-classified from class I to class Ir) would get an additional transition period, you probably will have to fulfil some requirements from MDR in May 2020 at the latest. The corrigendum still has to be agreed upon and published before we know more! Doing nothing would be completely wrong and one could call it "regulatory suicide".
As an authorized MDR auditor I want to point out, that the audits, both under MDR and MDD, will verify that you’ll adhere to MDR requirements as applicable prior and/or after May 2020. Auditors will verify that you switched to new vigilance rules and that PMS duties will be fulfilled, including trend reporting. No significant changes to any product under MDD is allowed after May 2020, no allowance to place pure class I products on the EU27 market after May 2020. You must have a PRRC (article 15) with adequate job description and qualification. National registration requirements, e.g. DIMDI in Germany, will continue to apply.
Don’t be afraid of the news that a huge amount of additional guidance documents are still to come and that expert panels may not be ready in time. Don’t worry if your notified body was not notified yet. Anyhow, you cannot influence that personally on your own. There is enough workload out there for all of us to be done, now. If we don’t know the unknowns yet we still can work on the knowns and get stuff done in time.
Please understand the EUDAMED delay should be considered like an extra time in a knock-out competition. It is your unexpected (maybe not really unexpected) opportunity to catch up the time lost so far when implementing MDR and to realign priorities to get closer to your own MDR readiness! Remember that the final draft of the MDR was published already 979 days ago (Feb 22, 2017). It will be difficult explaining to authorities, why you did not get ready yet. Make sure that you will you use the extra time granted. It is not unlikely that confusion will continue and that the knockout competition will end in a quite long MDR penalty shootout or even a never ending MDR tiebreaking.