Registration in the UK
Drafting and updating of UK registration: UKRP & UKCA
To register a medical device in Great Britain (England, Scotland, and Wales), manufacturers must register with the Medicines and Healthcare products Regulatory Agency (MHRA) and ensure that the device complies with the UK medical device regulations (UK MDR 2002).
Maytal, through its direct presence in the UK, supports medical device and IVD manufacturers in navigating the UK regulatory landscape to achieve UKCA compliance and market access, acting as the UK Responsible Person (UKRP)and assisting manufacturers in the preparation, review, and maintenance of the technical documentation in accordance with UK MDR requirements.
As the UK Responsible Person (UKRP), the Maytal team manages the registration process on the MHRA portal, ensuring that all required documentation is accurate and complete.
Maytal also provides support in managing relationships with the UK Approved Body during the UKCA certification process, helping manufacturers overcome regulatory challenges and ensuring timely access to the UK market.
Finally, Maytal can support UK-based manufacturers in obtaining CE certification for access to the European market, acting as the European Authorised Representative (EU Rep).
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