Regardless of type of IVD, there are certain common requirements to place your device on the EU and UK markets.
Both the EU and UK law require from manufacturers to:
1. Have a Declaration of Conformity: both regulations require manufacturers to have a Declaration of Conformity stating compliance with the applicable legislation.
2. Compile a Technical File for your IVD: The Technical Documentation should cover, among others, a device description and specification, labels and instructions for use (IFU) of the device, design and manufacturing information, a benefit-risk analysis and risk management, product verification and validation, etc.
3. Have appropriate CE/UKCA Certificates if needed.
4. Mandate European Authorised Representative/UK Responsible Person to represent you on the two markets and verify the compliance.
5. Affix the CE/UKCA mark to your device upon compliance with applicable requirements.
6. Comply with language requirements on labelling and instructions for use.
As EAR and UK RP experts in the IVD field, we can assist reaching compliance on both territories, so you market your devices safely and without any risks of non-compliance.