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You can stay update with the latest news and announcements for medical devices through our enews updates.

BSI is now accepting applications for MDR

We can confirm that BSI is now accepting applications under the MDR for our UK Notified Body (0086) from 3 June 2019.

BSI UK Notified Body (0086) will begin to process quote requests and schedule work over the coming months. BSI will provide conformity assessments to the full scope of the MDR. This service will focus on our existing UK (0086) and NL (2797) clients. For further details on BSI’s scope, please visit the NANDO information system.

Who can I contact for further information?
Please contact your Account Manager to initiate the quotation process. They will be able to answer your questions in the first instance, and we recommend you use the free material:

BSI has a dedicated resource for your MDR Transition
Listen to one of our free webinars or read through the BSI whitepapers

Recent enews

BSI Medical Devices Brexit Update November 2017 >

Following the triggering of Article 50, BSI will continue to help organizations achieve their goals as we have done for the past 116 years.

06 May 2017

New Medical Devices Regulation and IVD Regulation text published >

The final texts of the new European Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) have been published in the Official Journal of the European Union today. The Regulations will enter into force on May 26th, marking the start of the transition period for manufacturers selling medical devices into Europe.

12 April 2017

EU referendum result >

BSI’s role as an EU Notified Body will not change following the recent UK decision to leave the European Union.

14 April 2017

BSI opening a second EU Notified Body based in the Netherlands >

BSI continues with it's plan to open a second Notified Body based in the Netherlands. Following the application made in February, next steps are a Joint Assessment of BSI by EU Competent Authorities and European Commission representatives later this year.

11 April 2017

BSI’s role as an EU Medical Devices Notified Body >

BSI’s role as an EU Notified Body will not change following the recent UK decision to leave the European Union. The triggering of Article 50 on 29 March 2017 marked the start of a period during which the UK government will be negotiating the arrangements for its withdrawal from the EU and its future terms of trade with Europe and the rest of the world.

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