For a product to be placed on the European market, it must meet the requirements in the relevant regulation and be affixed with a CE Mark. The current EU regulation for MedTech products is undergoing change, with the existing Medical Device Directive (MDD) being replaced by the new Medical Device Regulation (MDR), first published in 2017.

1) The existing Medical Device Directive (MDD) is being replaced by the Medical Device Regulation (MDR)

The culmination of eight years’ work, the MDR will ensure that European regulation for devices is considered the ‘gold standard’ globally. For our industry, this new regulation modernises the original MDD rules, bringing together best practices from existing commission guidance while covering newer technologies such as nano-materials and human tissue derivatives.

 

Post-Brexit, EU and UK MedTech regulations may differ

 

Owing to its complexity, a three-year transitionary period is necessary to allow companies to move from the old regulation to the new. As a result, all new products must be fully compliant with the MDR by May 2020. However, ‘day one’ of Brexit is March 2019, which is mid way through this compliance period.

2) A three-year transitionary period is necessary for companies to move from the old regulation to the new.

The moment we leave the EU, our sector’s regulation could potentially diverge from the rest of Europe.

If we are to ensure a healthy and thriving MedTech sector after March 2019, there should ­– at least initially – be continued recognition of the MDR and the continued validity of CE marked products currently on the market. This is a view supported by 97 per cent of ABHI’s membership who, in a recent survey, stated they were in favour of regulatory convergence with Europe.

 

3) Varying from EU regulations risks UK patients’ early access to new products.

For MedTech companies, the CE marking process is not just the seal of approval needed for access across Europe, but it is a mark used by other jurisdictions outside the EU as a basis for market entry. If the UK is to remain competitive, it is critical we remain part of this system. 

Furthermore, the high international esteem of UK regulators, and the English-speaking environment (which has utility throughout Europe) makes the UK very attractive. As such, the UK often enjoys first sight of many innovative MedTech products. The benefit of this to patients is obvious and we must protect this advantage.

 

UK-made, internationally sourced 

 

It is vital that we have sensible trading agreements in place from day one. “Complex, international supply chains mean that products manufactured in the UK cross the UK/EU  border many times during their lifecycle before reaching patients. Currently, that border is frictionless; we must protect this in order to keep developing and delivering MedTech innovations. The industry is calling for all products used in healthcare to be exempt from any new customs, tariffs or VAT arrangements, and afforded pre-shipping clearance and fast track access across any new EU/UK borders.

While Brexit remains highly political, one thing that cannot be debated is the need for UK patients to be able access innovative MedTech and we are hopeful policy makers will recognise this.