An update on Brexit and BSI Medical Device Notified Body: May 2018

E-news: 4 May 2018

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 has now achieved Accreditation for ISO 13485 under the Dutch Accreditation Council (RVA); this is a major advancement in our preparations for Brexit contingency plans.

Brexit: Current status and timelines

As we move through 2018 and the negotiations continue around the future relationship between the EU 27 countries and the UK; it is anticipated that an agreement will be reached in autumn 2018. The UK is scheduled to leave the EU on 29 March 2019, at which point all EU law will remain applicable to the UK, including the full requirements of the MDD, AIMDD and IVDD. The laws will maintain alignment with EU law during the transition period, currently proposed until 31 December 2020.

It is assumed a Mutual Recognition Agreement (MRA) will be agreed which will maintain these laws following 2020.

The MDR and IVDR will not be fully applicable at this point, so only the limited applicable provisions of the regulations will be copied into UK law. The concern will be the same for many pieces of EU law, and as such we expect an agreement to eliminate this issue. We will continue to provide you with further updates on this, as and when facts appear.

One BSI, Two Notified Bodies

We are making significant progress regarding our applications for completing our business out of our already active Amsterdam office.

  • BSI has formally applied for designation as a Medical Device Notified Body in the Netherlands under the EU Directives - (90/385/EEC) Active implantable medical devices, (93/42/EEC) Medical devices and (98/79/EC) IVD directive - within the oversight of the Dutch Health and Youth Care Inspectorate (IGJ). IGJ has completed our initial audit, and we are working through the process of designation, with a target of designation in July/August 2018. Our application for the MDR and IVDR is currently in the first wave of applications for these new Regulations.
  • BSI has now achieved ISO 13485 Accreditation under the Dutch Accreditation Council (RVA); this is a major advance in our preparations for our Brexit contingency plans: the RVA accredits management system certification bodies based on the ISO/IEC 17021 standard.

BSI is currently in talks with both IGJ and MHRA to ensure pragmatic processes for working across the two Notified Bodies and how we will manage any migration of certificates and clients, should this be a requirement. It is understood that any movement of certificates will be a purely administrative process, with limited impact on our clients.

As we will be sharing the information between two BSI subsidiaries and be able to maintain full traceability and linkages to the current certificates, we can ensure continued patient safety. Product labelling will need to be updated. However, we anticipate that due to continued traceability, the short timelines usually associated with a NB transfer will not be upheld and should allow you to transfer the labelling over during your normal product lifecycle plans, as new products are introduced or during the change to the new Regulation.

Planning for Brexit in your business

BSI continues to work closely with all relevant UK government departments including the Medicines & Healthcare products Regulatory Authority to ensure they understand the implications not only for UK Notified Bodies, but more importantly for our clients and patients who use these products.

However, there are aspects of the anticipated changes which we recommend you should start to consider and plan within your business, specifically around control of your supply chain. We will cover this subject in more detail during the free BSI webinar.

We would like to invite you to join us for a Live Webinar: ‘What are the regulatory implications of Brexit?’

Join Gary Slack, Senior Vice President Global Medical Devices, for a 50-minute webinar. 

The webinar will review the status and implication of Brexit and how these will impact the implementation of both the MDR and IVDR. Gary will outline BSI’s plans and the contingencies we have in place to deal with the uncertainty caused by the UK withdrawal from the EU.

Date: 23 May 2018, at 15:30 BST.

Register here, if you cannot attend we will send a link to you which will allow you to listen back.

Where can I find more information?

BSI will continue to keep you updated as the negotiations progress. For now, we would like to assure you that BSI will continue to provide EU market access as we have done since the inception of the three EU Medical Device Directives. Please check our Brexit web page for the latest information available and ongoing updates. If you have any questions or concerns, please contact your normal BSI contact at any time.