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BSI UK has become the first notified body in the EU to be designated under the new Medical Devices Regulation (MDR), which fully applies on May 26, 2020. It has been designated for the full scope it applied for in November 2017 and will "very shortly confirm when we will commence taking applications to the MDR."

The good news is that the EU machinery has succeeded in making a designation some six or seven months ahead of the July 26 date that the EU Notified Bodies Operations Group had indicated was likely in late November in its NBOG BPG 2017-1 guide.

Also, now that it is clear that the lengthy and complex designation process does work, and has borne fruit ahead of predicted timelines, the medtech industry will be hopeful that more designations will come through so that device manufacturers can get on with the very important job of demonstrating compliance with the MDR ahead of May 26, 2020. The sector is very concerned about potential bottlenecks at notified bodies because of the huge demand there will be for conformity assessment against the new Regulations within tight timelines.

Good News, But Relevant EU Structures Awaited

While this is good news and means that notified bodies can start to assess applicants against the MDR, the fly in the ointment is that a great many documents and structures remain incomplete and so it looks very difficult for any CE marks to be granted yet against the MDR, however ready companies may be. Of course, this will depend on product types and risk categories, and how much of the system is up and running in a given area. For this reason, it is vital that companies continue to monitor developments very closely.

This is not always easy, however. The designation of BSI as the first notified body under the MDR is a landmark event for the medtech sector, but it almost went under the radar: there had been no sign of a press release from BSI itself, nor any notice on the European Commission's website for medical devices, or alerts, asMedtech Insightwent to press.

Bad News As Brexit Complications Loom

The bad news is Brexit; BSI will become a UK-only notified body if there is a "no-deal Brexit" on March 29, 2019, and, at that point, the value of certificates to the EU27 will become null and void.

BSI is already prepared to deal with this, and has been able to create a relatively simple structure for transferring certificates from BSI UK to BSI NL, a sister branch established in the Netherlands.

MedTech Europe Reaction

Speaking on behalf of the EU medtech trade association, MedTech Europ, Oliver Bisazza, director of regulations and industry policy said his association welcomes the news.

"Earlier would have been better, but this development happened a good six month earlier than originally expected," he said. "We certainly hope that more notification decisions will follow soon, for both Regulations."

He added that, in the context of Brexit, it is important for the medtech industry that a deal addressing the status of UK notified bodies is urgently agreed. "We hope." he said, "all other UK notified bodies will follow BSI's lead, establish themselves in the EU27 and be designated to old and new legislation as soon as possible."

Nando Database Listing Confusion

BSI states that the actual date of designation appears to bebeforethe end of 2018, butMedtech Insightnotes that it had not appeared in the European Commission database on notified bodies, Nando, under the MDR page by the end of the first week of January 2019.

This may be explained, however, by the fact that it generally takes several weeks for listings to appear in the database.

IVDR Designation News Still Pending

There is no listing yet to show that BSI – nor any other notified body – has been designated under the IVD Regulation, which full applies on May 26, 2022. But the UK organization applied for such designation on the same date as for the MDR.

News is also still awaited about designation of BSI Netherlands, which recently became notified against the current medical device directives and which has applied for designation against the MDR and IVDR.


From the editors of Clinica

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