Brexit Q&A: Where Do Notified Body, Authorized Representative Offices Need To Be?
Medtech regulatory service providers cannot afford to "wait and see" on the final outcome of Brexit. Questions such as the appropriate base of operations to serve device companies looking to sell into the UK and the EU are swirling. So how should the sector be covering its back? Medtech Insight spoke to John Adcock of Advena, a consultancy that serves as an authorized representative, to find out his views.
You may also be interested in...
The uncertainty over the UK position in Europe, on top of the questions surrounding many aspects of the implementation of the EU’s forthcoming medtech regulations, is making any efforts at planning difficult for many in the medtech sector. But indications are that the UK will be on board the EU medtech ship a while longer.
With finite resources, the UK’s regulatory agency responsible for health care products is rapidly addressing COVID-19 medtech issues. But shifting its focus will cause delays elsewhere.
Non-CE-marked products on the EU market, virtual notified body audits, free standards and the Commission bid to pause the MDR. March has seen unprecedented developments as COVID-19 has railroaded through the sector decimating regulatory rules and plans.