All medical devices sold in the UK market need to be registered with the Medicines and Healthcare Regulatory Agency (MHRA). Manufacturers based outside the UK are required to appoint a UK Responsible Person to carry out specified tasks in relation to the manufacturer’s obligations. The responsibilities of the UK Responsible Person are set out in the UK MDR 2002.
With more than 65 years’ combined experience in the UK orthopaedics and spine market, we’re ideally positioned to be your UK Responsible Person, and to support you with the tasks needed to market your medical device here: getting your device certified, ensuring device conformity and registering your device with the MHRA.
The service includes:
A highly experienced medical device professional with a large set of skills at quality management systems and regulatory affairs of medical devices and in vitro diagnostic products (IVD), Edna joined the group as Quality and Regulatory Officer in 2020.
Edna has a background in production processes, import, distribution and registration processes (Brazil, EUA and Europe) as well as internal audits and validation methods.
Medical Device Manufacturer
Based in France, our client was a medical device company that develops and distributes implants dedicated to treating forefoot pathologies. As the appointed UK Responsible Person (UKRP) liaising with the UK Medicines and Healthcare products Regulatory Agency (MHRA), our goal was to provide hassle-free device registration within a short timeframe that ensured we prevented any disruption to the business.
Based in the US, our client was a orthopaedic company that develops and distributes speciality instruments and implants. A well-established player in the UK market, the client was exporting Class I, Class IIa and Class IIb devices to the UK pre-Brexit, CE-certified under EU MDD.