Medical Devices are one of, if not the most, complicated, and tightly regulated products to place on the market within the European Union and the United Kingdom. This is not helped by the change from the Medical Device Directive to the new Medical Device Regulations which come into force in May 2021. This has been further complicated by Brexit as different regulations apply in different areas.
The first step is to identify if the product is actually a Medical Device and then which of the Regulation actually applies. Keep reading, and learn what you must know in this article written by International Associates Limited in the UK. Continue reading Medical Devices EU Authorised Representative & UK Responsible Person – Q&A: International Associates Limited