BSI Medical Devices and Brexit

As you are aware Brexit is posing many questions and uncertainties in our sector so we would like to update you on the latest information we have regarding Brexit and your Medical Device Notified Body.

EU Commission data indicates that approaching half of all medical device products certified in the EU use UK Notified Bodies; BSI is Europe’s leading Notified Body for high-risk medical devices. We have a strong contingency plan in place to ensure that you, our global clients, can continue to use BSI as your European Notified Body but we also wanted to provide you with some wider information to support this substantial change.

BSI is delighted to formally announce our successful designation under the existing 3 Medical Device Directives (MDD/AIMD and IVDD) in the Netherlands. These designations represent a significant milestone in our Medical Device Regulatory activity and more than two years of work in achieving this milestone. This firmly anchors BSI presence as a Medical Device notified body irrespective of the BREXIT outcome.

It is important to note that BSI’s strong preference remains to develop the new NL NB in parallel to our successful and growing UK Notified Body. Also, to ensure both NB’s progress towards successfully achieving MDR and IVDR designation, working closely with our very supportive competent authorities the MHRA (UK) and IGJ (NL).

To ensure market access specifically for either option two or three (see above), we started the process of applying for full scope Notified Body status in the Netherlands under both existing and forthcoming regulations in September 2016. Current status:

• RVA accreditation for manufacturing facility certification (ISO 13485) completed April 2018
• Medical Device Directive designation (MDD, AIMD, and IVDD) received in November 2018

See the latest updates from the MHRA

Access the latest updates and resources from the Medicines and Healthcare Products Regulatory Agency (MHRA).

Feb 2019 - European Commission Q&A relating to the UK's withdrawal from the European Union with regard to industrial products.

This list of questions and answers gives further guidance on the basis of the Notice in a situation where the UK becomes a third country on 30 March 2019 at 00:00h (CET) ('the withdrawal date') without a ratified withdrawal agreement.

Feb 2019 - Regulating medical devices in the event of a no deal scenario

This guidance follows on from the further guidance note published on 3 January 2019. This guidance will apply from exit day subject to the The Medical Devices (amendment) (EU exit) Regulations 2019 being passed.

Jan 2019 - Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal

This guidance is intended to update stakeholders on the UK’s proposed arrangements for the regulation of medicines, medical devices and clinical trials, if we leave the EU on 29 March 2019 with no deal, so they can make informed plans and preparations.

Jan 2019 - MHRA releases response to consultation on EU exit no-deal legislative proposals

Following our consultation on how medicines, medical devices and clinical trials would be regulated in a no-deal scenario, we have today issued updated guidance setting out the UK’s proposed arrangements for regulation if we leave the EU on 29 March 2019 with no deal.

Aug 2018 - "What the implementation period means for the life science sector"

This update discusses how the life sciences sector would be affected by the agreement on recent developments regarding terms for an implementation period.

Aug 2018 - "Technical information on what the implementation period means for the life science sector"

This document provides more detail on the impact of recent developments on the life sciences industry.

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