MDD to MDR transition - Time required for the implementation of the MDR

[joemar]

Hi Everyone,
Im getting conflicting signals on the transition time required/allowed for the implementation of the MDR. Talking to my notified body at my last audit, they strongly implied that we would have to implement the MDR by May 26, 2020 as defined in Article 123 of the code. But talking to my EC Rep, they were telling me that that is bullshit, and that our current MDD certificate is in force until it expires, which in my case is 2024.

Paragraph 2, of Article 120 of the MDR (on transitions) states: "Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void at the latest on 27 May 2024. "

Paragraph 3 states: " However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives."

My question is, am I missing anything here? Is it possible that my certificate remains valid but I am require to conform to the MDR in all aspects, or just the ones in paragraph 3? Or does the certificate mean that it is valid, and my quality system is covered until it expires?

 

[Watchcat]

Has this notified body been designated under the MDR?

 

[Philip B]

Our MDD certificate runs until May 2022 and we have been told by our Notified Body (BSi) that it is valid until this date. The only provisos are that the post-market surveillance and Vigilance requirements of the MDR will apply from this May regardless and that we will not be able to make any significant changes to our MDD certificate after May.

 

[joemar]

Has this notified body been designated under the MDR?

yes. but they werent at our last audit when they let us know that they would be interested in reviewing our MDR compliance.

 

[Watchcat]

Until now, I would have said, whatever your NB says. But now I understand that the EU Reps are dealing with more liability, and therefore are getting more involved.

Perhaps you could introduce your NB to your EC Rep, and tell them to let you know what they decide?

There is no reason for manufacturers to be caught in the middle of a disagreement between their NB and EU Rep. They need to get on the same page, or you probably want to replace one of the two. Otherwise, you'll be spending a lot of time and effort playing referee to a rock and a hard place when there are far more pressing matters you need to attend to.

All that said, your certificate may remain "valid" as a certificate, but my understanding is it won't continue to be valid without an NB willing to support it. What your auditor may have been telling you is that your NB doesn't want to continue supporting MDD certificates. so you can either move over to the MDR or you can find yourself another NB, and good luck with that.

 

[Ivan Togo]

Our NB too, TUV Sud South Asia, pushing for MDR.
They are informally giving review comments and saying it will be difficult to clear under MDD and 'recommending' us to go for MDR.
We, in not so direct terms, told them, 'if you want us to consider you for MDR, please give us MDD now'.
The NB, TuV Sud in Bangalore is arm-twisting and misusing their position, harrassing its captive customers to get more business.

 

[Watchcat]

Our NB too, TUV Sud South Asia, pushing for MDR.

When you say "difficult to clear under MDD," are you referring to an original certificate, or to the renewal/extension of an existing certificate?

 

[Watchcat]

The NB, TuV Sud in Bangalore is arm-twisting and misusing their position, harrassing its captive customers to get more business.

I fear you are woefully out of touch with the EU reality. Perhaps your Bangalore contacts are actually trying to be diplomatic, because the reality is pretty harsh. First of all, the NBs do not need your business. They have more than they can handle.

The other reality is that there may never be more than 20-30 MDR-designated NBs, where just a few years ago, there were 80 MDD-designated NBs. So it's going to be a seller's market, quite possibly forever. The NBs will be able to choose which clients they want, and which clients they don't want. Many smaller companies will never get chosen, and will most likely never get their medical device products CE-Marked.

NBs are also fully booked with MDD renewals through May 26, so if one tells you it can renew your certificate by then, you would do well to jump on that offer. If one tells you it can issue a new MDD certificate by then...well, like I said, perhaps your Bangalore contacts are being "diplomatic."