MDSSAR News & Events

2023-05-10T00:00:00+02:00

Notified Body Confirmation Letter is published! Free of charge.

We are pleased to announce the publication of the Notified Body Confirmation Letter! This letter is an essential document that manufacturers can use to demonstrate the extension of the additional transitional period for their legacy devices with expired MDD certificates, as permitted by the regulation EU 2023/607 amending the Medical Device Regulation (MDR).

The European Commission has provided helpful guidance in Question 7 of the Q&A document, available at this link. Among other solutions, additional evidence could be provided by a confirmation letter issued by the notified body. While some notified bodies may have reservations about the last sentence of their involvement, it is important to note that they have collaborated extensively to create a harmonized version of the confirmation letter. You can find the harmonized template here.

With the last sentence, the Commission has suggested that this confirmation letter be provided free of charge "Such confirmation letter could be based on a harmonised template and be issued, in principle, without extra costs". However, it is important to recognize that while the letter itself may not incur an additional cost, notified bodies may have different pricing structures throughout the MDR certification process.

We appreciate the diligent efforts of Team NB in promptly developing a harmonized template for the confirmation letter. This standardized approach will help ensure clarity and consistency for manufacturers seeking to benefit from the extension of the transitional period for their legacy devices.

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Categories: News

Tags: EU Notified Body

2022-11-15T00:00:00+01:00

Notified Bodies survey on Certifications and Applications under the MDR and IVDR

Check out the results of the Notified Bodies survey on certifications and applications under the MDR and IVDR published by the European Commission.

Check out the PDF file: md_nb_survey_certifications_applications_en-1.pdf

More information can be found here: https://lnkd.in/ehVE5svJ

Categories: News

Tags: Notified Body MDR IVDR

2020-02-14T16:17:36+01:00

Notified body number 11!

The notified body (NB) designation is moving along. Congratulation to NSAI. We have to note the scope NSAI shows as one of the smaller notified bodies. It includes active implantable medical devices. Well Done!

However, we like to congratulate all NBs who have made it to the Nando Website as of today.

Early this year it was communicated that 3 more notified bodies are in the pipeline. After DNV GL Presafe and NSAI we are waiting for the third one to be published. We may not see a big wave and we may see the majority of NBs notified after May 26 – the application date of the MDR!

This means that the additional transition as provided by MDR Article 120 (3) is the norm and not the exception.

What else is there to note:

1. BSI UK is still listed and will stay on the list because the Brexit deal provides for business is as usual - at least until the end of this year (see MDSS N&V here).

2. The notified bodies must train all the auditors and experts to the MDR requirements. They must be reviewed in regards to their qualification and experience (see MDR Annex VII). This is a lot more cumbersome as with the directive. Clients reported that their auditor stated that they would not come back due to their lack of qualification under the MDR. I guess someone may ask the question whether those were actually qualified under the MDD!

3. Even before quoting the service the NB shall conduct a preliminary verification that the product is covered by the MDR and the classification (Annex VII 4.2 d).

4. Article 50 requires the Notified Body to publish the list of their standard fees. This will be interesting to see whether you will be able to estimate the final cost and Annex VII requires to have all costs fixed in procedures for the different activities. How can a notified body know what resources it takes if the service was never applied! This only can mean high estimates of fees in the beginning and we only can hope that some of the prices communicated may drop in the near future upon the actual experience.

There is a lot more to say. Be aware of the NB requirement in MDR Annex VII to be prepared for the new NB process.

The below is a screenshot from the Nando website.

Categories: News

Tags: MDR notified body

2020-02-06T00:00:00+01:00

Grace Period offered for products who lose the notified body without fault!

Guidance was always in place in the EU for a Grace Period (GP). However, it is always up to the member states (MS) to follow a guidance. The MHRA has applied GPs but commits itself now with a solid process. Other countries have given GPs. Among them Germany, Switzerland, etc.

MDSS as the EC REP has applied on behalf of a client with its Competent Authority (CA). This allowed the client to sell his products without a NB certificate for a defined period. For manufacturers outside the EU it is important to know that the relevant authority is the authority of the EC REP - not the authority of the NB. It is not a trivial process and requires some negotiation skills!

With the conditions, it is an individual process, which also takes resources away from the MDR implementation. The good news is that you will be able to sell the product EU wide.

Contrary to this, article 59 MDR or article 11 (13) MDD allows MS to permit the selling restricted to their territory.

The big questions is what happens in terms of the Brexit. The MHRA GP may only last until the end of 2020 if there is not a trade agreement covering this aspect.

Here the MHRA reference.

Categories: News

Tags: notified body