Medical devices industry calls for post-Brexit regulatory alignment
27 September 2017 / Europe,
Trade associations representing the medical devices and in vitro diagnostics industry in Europe and the UK are calling for continued regulatory alignment after Brexit.
In a joint letter to EU negotiator Michel Barnier and his UK counterpart David Davis, the heads of the Association of British Healthcare Industries (ABHI), the British In Vitro Diagnostics Association (BIVDA) and MedTech Europe say there are five "critical factors" which must be part of any agreement to ensure the stability the industry needs.
These are for:
the UK to remain an active part of the European regulatory framework (CE marking regime) for medical devices and in vitro diagnostic medical devices, under a full implementation of the new Medical Devices and In Vitro Diagnostic Medical Devices Regulations;
the UK notified bodies to remain European designated notified bodies;
legal entities, such as authorised representatives or legal manufacturers, located in the UK to be considered as "European-based" under the new regulations;
the Medicines & Healthcare products Regulatory Agency (MHRA) to participate formally in the European Commission’s new Medical Devices Coordination Group (MDCG); and
the UK to continue having full access to – and reliance on – the newly set European Database for Medical Devices (Eudamed), including EU-wide pre- and post-market data, registration of economic operators, and details of clinical investigations.
The three chief executive signatories to the letter were Peter Ellingworth (ABHI), Doris-Ann Williams (BIVDA) and Serge Bernasconi of MedTech Europe.