Medical Device - Registrations
The key qualifications for the introduction of a medical device into the market in Great Britain include: complying with regulations, obtaining MHRA registration.
Any medical device, such as an in vitro diagnostic device (IVD), a custom-made system, or a procedure pack must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) before they can be placed on the market.
If a manufacturer is based outside of the UK, they must appoint a single UK representative.
Medical devices in the UK are divided into four categories, matching those used in the EU: Class I, IIa, IIb, and III. Class I represents the lowest risk, while Class III is the highest.
EOMI consultancy is able to help UK or Non-UK based company to get their products registered with MHRA in the UK. We can also act as UKRP for companies based outside United Kingdom.
EOMI Consulting has achieved success in registering more than a thousand devices with the MHRA for customers. Should you need advice on ways to expedite your medical device registrations, please don’t hesitate to contact us.
We can help companies register with EUDAMED.
For further details, please Contact Us