The Secretary of State for Health and Social Care, Matt Hancock, has recently written to suppliers of Medical Devices and clinical consumables to update them on preparations for a potential no-deal Brexit. This letter explains what the health and care sector needs to consider in the period leading up to March 2019, including the continued supply of Medical Devices and clinical consumables and the changes to government planning assumptions, in order to safeguard patient care after the so called “Brexit date”.
Since the publication of the new European Medical Devices and In Vitro Diagnostic Regulations (MDR and IVDR respectively) in April 2017, the MHRA has been actively publishing many different guides to assist the Medical Device and IVD industry navigate through the new and expanded obligations for all economic operators. Considering the broader scope of the new Regulations and focusing their efforts in providing support to both new and experienced users with their implementation plans, Guidance for manufacturers of products listed under Annex XVI of the Medical Device Regulations (MDR) was published in October 2018. Annex XVI comprises a list of groups of products without an intended medical purpose (i.e. aesthetic products, contact lenses, etc.) as referred to in article 1(2) of the Medical Device Regulations (MDR), resulting in a broader scope of the previous legislation.
The MHRA is currently developing guidance for health institutions wishing to apply the exemption to the new Regulations (MDR and IVDR) and its consultation will run until March 31st, 2019. All this collaboration reflects MHRA commitment to engage with and implement the new European Regulations in the UK.
Besides, the MHRA recently updated the healthcare sector about planning for a potential worst-case no-deal Brexit scenario to ensure that the flow of all these products will continue unimpeded after March 29th, 2019. A range of contingency measures was initially established to maintain the continuity of supply of Medical Devices and the continued movement of products into the UK from the EU, as well as to address potential border delays. Government departments have been working to design customs and other control arrangements at the UK border in a way which ensures goods can continue to flow into the UK country, and won’t be delayed by additional controls and checks. It has been also communicated that no additional controls or checks will be implemented on the UK side and that the Medical Devices and Clinical Consumables Supply Contingency Planning Programme officials will provide more updates soon.
The latest information on Brexit and the European Regulations implementation can be found in the Agency website and automatically received through Magellan platform. Please request a short demo with our team for more details on how we could keep you aware of global regulatory updates in the Health care sector.