A quick overview of the requirements and process for a Medical Device manufacturer (mfr) wanting to place their devices on the EU & GB Markets is shown below.

The following is a list of the actions and the order in-which they should be performed:

• Technical File (TF) / Documentation.
  The mfr creates a TF that covers all devices and meets the requirements of the Medical Device Regulation (MDR 2017/0745), Annex II & III;
• Declaration of Conformity (DoC).
  The mfr creates DoC(s) for all devices. The TF is the compliance supporting evidence of the DoCs.
• Compliance documentation review.
  The mfr submits the TF and DoC(s) to their EU Authorised Representative / UK Responsible Person (EUAR / UK RP). The AR / RP is required to review the documentation to ensure the mfr is meeting their compliance obligations.
• Medical Device Registrations.
  For the GB market, the RP registers the devices on behalf of the manufacturer with the MHRA. For the EU market, the manufacturer can register the devices with EUDAMED themselves.
• Notified Bodies and Certificates. (EUDAMED only)
  The mfr links their registration to the Notified Body that issued the certificate, as applicable.
• Market Surveillance. EUDAMED & MHRA
  The mfr completes requirements relating to the Market Surveillance module of EUDAMED. The mfr
  registers themselves on the MHRA Manufacturer’s On-line Reporting Environment (MORE) portal.

The following details are needed to complete your MHRA and EUDAMED medical device registration:

• Basic UDI-DI;
• EU Authorized Representative details;
• Device classification;
• Device Trade Name(s), Model(s), Reference/Catalogue numbers;
• CE Certificate details, if applicable;
• UDI-DI Number(s);
• GMDN and EMDN code(s);
• Countries where the device is, or will be, marketed;
• Device characteristics, such as: single use, sterile, contains latex, storage handling conditions and critical warnings or contra-indications, if applicable;
• Company responsible for design, if not the registered manufacturer;
• Company responsible for manufacturing, if not the registered manufacturer.

Eurolink Product Registration and Notification Services include:

• Providing advice on the registration requirements for different products, including Medical Devices 
• Providing Clients with access, when necessary, to registration portals
• Registering Clients and their products with EU, UK and other national competent authorities
• Payment of registration fees on behalf of our Clients
• Maintaining compliance records in line with product development
• Informing Clients of changes to legislation and registration requirements

Please be aware that these services are only available to clients for whom Eurolink acts as an Authorised Representative or Responsible Person in the EU and/or UK.