With Brexit looming, Paul Brooks, executive director, Regulatory Affairs Professionals Society (RAPS) discusses how medical device companies should respond to the EU's new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
Brexit
The medical device sector is in a state of significant uncertainty. Preparations for the EU’s new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are creating challenges for regulatory professionals, and the uncertainty surrounding Brexit is equally problematic.
Clarity on the operational trade and regulatory post-Brexit environment is urgently needed. It remains unclear whether the UK will align its regulations and regulatory processes for pharmaceuticals and medical devices with those of the EU, with reciprocal acceptance by other EU Member States, and this is undermining future regulatory planning and confidence.
Currently, there are too many variables to be able to accurately predict what the future holds for UK pharmaceutical and medical device companies post-Brexit. It is similarly difficult to forecast what the wider economic and logistical impacts will be on the pharmaceutical and medical device industries within the UK and the EU, as well as manufacturers outside the EU and UK wishing to place products onto the UK market
Failing to reach a desirable outcome could be a significant problem for the UK pharmaceutical and medical device markets as it could potentially lead to a duplication of regulatory efforts if the processes and procedures for the UK and EU significantly diverge and/or don’t achieve mutual recognition. This could have serious consequences, including increased costs, time and resourcing for manufacturers. It is anticipated that most companies are implementing contingency plans, based on incomplete information, so that they are somewhat prepared should negotiations fail to align regulatory frameworks and clearance between the UK and EU.
UK-based notified bodies will be similarly affected by Brexit, and most have implemented a plan B to move or duplicate their NB certification location to one of the 27 EU Member States to ensure continued recognition within the EU.
Regardless of the outcome of Brexit discussions, MDR and IVDR are set to be implemented over the next two years and four years, respectively, so advanced preparation and early action are key to ensuring a smooth transition to the new requirements. Manufacturers with strong regulatory resources, intelligence and structure will be much better prepared to navigate the new regulations, and these well-prepared companies will, no doubt, position themselves as the most competitive in the market.
Poorly prepared companies will not only jeopardise their own businesses, the entire European supply of medicines and medical devices could be in jeopardy as well. It is in everyone’s interests to ensure all the key players are ready for the regulatory changes.
UK agencies, including MHRA, have been proactive in helping the industry negotiate this tricky landscape. They have, historically, been very visible in Europe, ensuring that EU regulations have been pragmatic, favourable to innovation and forward-looking while protecting patient interests. All stakeholders have benefited from MHRA’s engagement in Brussels. The absence of MHRA’s perspective on future EU regulation negotiations could leave a vacuum in available regulator expertise that will certainly be noticed.
Future-proofing a healthy industry that best serves patients and healthcare providers is at the top of the UK’s agenda as talks continue. The ramifications to the sector and all stakeholders will be very significant if manufacturers can’t efficiently access the European and UK markets through aligned systems with mutual recognition.
As the healthcare product industry is not able to fully prepare for all the possible outcomes of Brexit as it stands, it’s imperative that it realises the increasing importance of its regulatory workforce in monitoring, influencing (where possible), interpreting developments, preparing contingency plans and reacting by delivering successful regulatory strategies.