Knowledge Center

It is looking more likely that a No-Deal Brexit scenario is coming as of 31st October 2019. With that, Medical Device manufacturers are further caught in the crossfire while already being pinned down by the upcoming EU Medical Device Regulation (MDR). This presents a number of difficulties with the UK being both a major manufacturer of medical devices but also a significant market for device sales for both UK and EU manufacturers. The MHRA has been actively updating guidance (Regulating medical devices in the event of a no-deal Brexit) for regulating medical devices in the event of a No-deal scenario. All information below is current as of 28th August 2019 and is subject to change.

 

Will the MHRA introduce new Medical Device Regulations following a No-deal Brexit?

The MHRA guidance is that medical devices will continue to be regulated as per the Medical Device Directive (MDD), Directive 93/42/EEC, and the Active Implantable Medical Directive (AIMD), Directive 90/385/EEC which were both previously transposed in UK law in 2002. This is good news for medical companies, both EU and UK based, as they can continue to maintain product on the market as long as they have a valid CE Mark. The MHRA has also stated that they intend to implement the EU MDR and transpose key elements into UK law following the same implementation timetable as the EU MDR.

 

Are there new requirements being flagged ahead of time?

New requirements that will be mandatory following a No-deal Brexit will require all manufacturers to register their products with the MHRA. In the case of non-UK based manufacturers (Europe or Rest of the World), they will have to designate a UK Responsible Person to act on its behalf who will register their devices with the MHRA. A requirement is that the responsible person must be based in the UK. In addition to registering non-UK based manufacturers’ products, the Responsible Person will officially communicate with the MHRA and keep documentation available such as the Declaration of Conformity and Technical Documentation available at the disposal of the MHRA. These requirements are similar to upcoming EU MDR requirements for all non-EU based manufacturers. Following these steps, any device which has a valid CE mark and complies with the MDD currently will still be eligible to be placed on the Market in the UK from the 31st October.

 

What about UK based manufacturers exporting to the EU?

Following the UK withdrawal from the EU with a deal or no-deal, all UK based manufacturers will require an EU based Authorised Representative to allow their product to be legally placed on the market. If none is in place, their product will? must? be removed from the market.

 

Do Medical Devices need to be registered with the MHRA immediately after 31st October to remain on the UK market?

The MHRA guidance states that a grace period for product registration will implemented as from the date of Brexit:

• Class III and Class IIb Implantable and Active Implantable devices – 4 months
• Class IIb non-implantable and Class IIa devices – 8 months
• Class I – 12 months

The guidance also states that in the case of custom-made devices, the manufacturer should register as per the risk classes outlined previously.

 

A £100 registration fee per product will be charged for the product registration. If a manufacturer fails to register their device, this will mean that they can no longer place their product on the UK market.

 

Are there issues if my Notified Body is based either in the UK or the EU?

The issue around UK based Notified Bodies has been well publicised over the last year with some Notified Bodies shutting up shop (LQRA and UL) and BSI UK shifting a number of clients CE certificates to their subsidiary in the Netherlands. Following a No-deal Brexit, UK based Notified Bodies and their CE certifications will no longer be recognised in the EU. CE certificates provided by an EU based Notified Body will continue to be accepted in the UK. Therefore, for any manufacturer that has not moved their CE certificates to an EU based Notified body, it is imperative to do so now to remain able to place product on the market not just in the UK but also the EU.

 

What if my company only sell's my product in the UK market?

There has been reports that a number of manufacturers are maintaining their CE Certificates with UK based Notified bodies as they largely sell their products in the UK market and do not export a significant amount. While this is a legitimate reason for not moving their CE certificate, it does mean that they will have to go back to the start of the application process if they do decide to sell in the EU or possibly rest of the world (E.g. Australia has a mutual recognition agreement to accept EU CE certificates) at a later date. With this, further investment will be required to re-approve in the future. 

 

Author: Dr Kieran Connole, Regulatory Affairs and Quality Compliance Consultant, Med-Di-Dia Ltd

 

About Med-Di-Dia:

We are a regulatory affairs and quality compliance consultancy located in Galway, Ireland focusing on the Medical, Digital Health and Diagnostic sectors of the European Life Science Industry. Our mission is to place regulatory affairs at the heart of every medical technology company and be the 'go to' consultancy for all your regulatory requirements.  If you'd like to know more about our services, please contact us.