Blog

Who must register In Great Britain devices must conform to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) as they apply in Great Britain so that they can be registered with the MHRA. Placing a device on the Great Britain market It is a requirement of the UK MDR 2002 that you inform the MHRA before you place…
Read more

When the UK leaves the European Union, a new role created under the UK MDR 2002 (as amended by the UK MDR 2019) becomes mandatory for manufacturers of medical devices. Those manufacturers NOT established in the UK need to designate a ‘UK Responsible Person’ to act on their behalf and to legally place medical devices…
Read more