Evnia proudly introduces a new service to offer UK Representation Services!
Our UK Responsible Person operational branch is ready to provide services to manufacturers located outside the UK, who are looking to place a medical device or an in-vitro diagnostic on the Great Britain market (England, Wales, and Scotland).
If you are in the search of qualified UK representation combined with extensive Technical Experience, do not hesitate to contact us.
Read more on our new dedicated website.
- for access to in-house, cross-functional, field-experienced regulatory professionals from various fields?
- to reduce the risk of non-compliance?
- to shorten your time to the market?
- for practical solutions that will prevent unnecessary costs and delays?
Evnia_UKRP can help!
The UK Responsible Person:
- registers the manufacturer’s devices with the MHRA before the devices can be placed on the GB market.
ensures and maintains the declaration of conformity and technical documentation are in place and an appropriate conformity assessment procedure has been carried out.
- provides the MHRA with all the information and documentation necessary to demonstrate the conformity of a device and acts as the contact person with the Agency.
- cooperate with the MHRA on sample requests, potential preventive or corrective actions, and risk mitigation measures when/where needed.
- immediately informs the manufacturer about complaints and reports from healthcare professionals, patients, and users about suspected incidents.
- An importer or distributor can also act as a UKRP.
- The name and address of the UKRP must be included on the product labelling or the outer packaging, or the instructions for use of UKCA-marked products.
Read more on the regulation of medical devices in the UK here.