YOUR SELEON SPECIALIST

Anne Matousek
Senior Consultant QM & RA, Regulatory Affairs Expert

Tel.: 07131 2774-40
regulatoryaffairs(at)seleon.de

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29.04.2021

WHEN THE CERTIFICATION PROCESS DRAGS ON ...

... then you should arrange everything at an early stage to have your products already on the market certified by your Notified Body in due time. Stumbling blocks and lengths are to be expected along the way.

Zulassungsstrategie
Zulassungsstrategie
Zulassungsstrategie
Zulassungsstrategie

Ready for MDR - Waiting for 26 May 2021.

Are you on the safe side when everyone else panics shortly before 26 May 2021? Then we assume that you have prepared yourself and your company thoroughly:

  • You have carried out MDR training.
  • The plan for the MDR transition is in place.
  • The processes for authorisation procedures, labelling, post-market surveillance (PMS) and vigilance have already been updated.
  • the Clinical Evaluation was revised
  • Basic UDIs for the products are available.
  • SRN was applied for via EUDAMED.
  • MDD certificates for the transitional period were extended recently.
  • the responsible person has been trained and appointed

With this in mind, you look forward to a breather before taking the next steps. You might think ...

 

But unfortunately, the approval or certification strategy is once again a major challenge. Surely you have your Notified Body in mind, is it already notified? If so, does the scope still fit your products? Or are you still waiting impatiently for the notification? Yes, there may possibly be some delays here, and the time until the expiry of your certificate may seem long to you now, but it can become too short very quickly.

In fact, it is likely that not all products currently certified under the MDD will be able to be certified under the MDR by May 2024, and this is for very simple reasons:

Too few Notified Bodies, too few qualified personnel for the review of the technical documentation and certification, and higher review costs result in a bottleneck in the implementation of conformity assessment procedures. With review efforts of up to twelve man-days for a Class III product, this is not surprising. It is to be expected that the processing time for certification applications can exceed one year. You should take this into account in your planning.

 

What should you do now?

Talk to your Notified Body first. Ask specifically about the expected processing times for your applications. At the same time, take a close look at your product portfolio. What is the class of your medical devices? What do you want to move to the MDR? And can you possibly group class IIa and IIb products into even better product groups? Which of these products account for the largest share of your turnover?

The certificate duration also has an influence, and if your best product has the longest transition period, do NOT start with it last. Class III products should not have to wait until the very end, as they will most likely take a particularly long time to process due to the considerably increased effort in the conformity assessment procedure (keyword: Scrutiny procedure). Here it may even make sense to submit two products as a pilot project so that you already receive feedback on the quality of the documentation for your other products, but the Class III products are already covered. Especially if you have several certificates or products of different classes and groups, you should seek discussion with your Notified Body.

 

The best-before date of the declaration of conformity

For the submission of the technical documentation, you also need the draft of your future Declaration of Conformity (DoC). As a well-prepared QM Representative, you have certainly used many of the offers, such as various training courses, descriptions of complex processes or definitions of best practices on websites, in order to meet the increased demands on your knowledge due to MDR and IVDR.

But finding all the publicly available information, understanding it and applying it in your own organisational context is very tricky and takes a lot of time. But whether you have understood and implemented those requirements correctly, you may only perceive much too late in many cases.

For example, you may be unsure about how to deal with the issue and validity of declarations of conformity, or rather, their best-before date (BBD).

 

Manufacturers have different approaches for issuing their declaration of conformity. Some are based on the validity period of their certificate. Others, however, issue their declaration of conformity on an annual basis. Some QM systems also require a declaration of conformity to be reissued in the event of non-significant changes. Under certain circumstances, conformity is declared on a batch basis.

For Class I products that need to be higher classified under the MDR, there are quite clear requirements based on the MDCG Guidance 2020-2 Rev. 1: "A valid Declaration of Conformity, according to Annex VII of the MDD, must be drawn up before 26 May 2021".

 

Unfortunately, there are no answers to the questions arising from the individual preparation of annual or batch-related declarations of conformity in this document. It only refers to the Blue Guide of the EU, which, however, is still on the status of 2016 and thus before the publication of the MDR in 2017. One could come to the conclusion that this sentence can also be transferred to higher-class products, but the class I products concerned are not yet based on a certificate in the context of which a notified body would be involved.

 

So what to do?

Finding out about such approaches, understanding them and developing appropriate derivations for your company is always time-critical.

But once you have done this, you can include your DoC in your technical documentation with a clear conscience.

 

What else is there to consider?

Of course, you also need a complete QM system in accordance with the requirements of the MDR for the application. You see, you can only rest later. Once this is done, submit the first file as a pilot so that you can then hopefully be successfully certified. "And then just bring the rest of the products up to date, submit and it's done. “

But here the next fallacy may already be lurking: Are you aware of how much time and resources the update of a technical documentation costs? Depending on the status of your current technical documentation according to MDD/AIMD, it can take a considerable amount of time and resources. Also, you should not wait for the final result of the pilot review before you start with the rest of the files. In the case of a very large portfolio, this can lead to you exceeding the term of your certificate in the case of a second application.

For the same product group, the further technical documentation will most likely only be checked during the surveillance audit; however, if you have several product groups, one technical documentation per group will be checked when applying for certification, and it may take another year or even longer to complete the procedure.

Remember that there is an application queue at your Notified Body: The later you arrive, the further back you will be.

How relaxed one can be if an MDR certificate for the products with the highest turnover is already available and thus enable a secure future for the company.

But even if your products should then still be in the queue for a certain time, do not panic. Talk to your distributors, pre-produce and sell the products to your distributors BEFORE the certificate expires so that they can continue to serve the market with your products until the MDR certificate is received, again keeping in mind the 26 May 2024 deadline for making available/putting into service.

 

Do you now also have the feeling that May 2024 doesn't seem so far away? Are you wondering where to start with QMS or technical documentation? Or do you simply no longer want to search for all the information and adapt it to your company on your own, because you simply don't have the capacity? Contact us. We will be happy to support you in the implementation of your MDR project.

 

 

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.

Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. seleon advises you on your individual questions without any obligation.

CONTACT YOUR SELEON SPECIALIST

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