Summary
The MDR and IVDR have significantly changed the regulatory landscape for medical devices in Europe, extending responsibilities and liabilities across the entire Economic Operator (EO) chain. Legal Manufacturers, Authorised Representatives, Importers, and Distributors now face greater post-market compliance obligations, supported by mechanisms such as EUDAMED, UDI requirements, and the Person Responsible for Regulatory Compliance (PRRC). For organisations based outside the EU, these changes can make maintaining compliance particularly complex.
One of the key challenges is the extended liability of Authorised Representatives and Importers. Under the MDR and IVDR, Authorised Representatives can be severally liable with the Legal Manufacturer for their products. This makes it essential for Economic Operators to verify technical documentation, accompanying documentation, EUDAMED registrations, declarations of conformity, and other compliance information before accepting responsibility for a device.
The article also highlights a practical enforcement concern: manufacturers may not always proactively inform their Authorised Representatives or Importers about newly released UDI-DIs or product changes. This creates additional risks when Economic Operators are expected to verify that devices and their documentation remain compliant. An IGJ inspection further demonstrated the importance of being able to document and demonstrate these verification activities.
Another important area is the PRRC. Both Legal Manufacturers and Authorised Representatives must appoint a qualified PRRC under Article 15 of the MDR and IVDR. Among other responsibilities, the PRRC must ensure that technical documentation is prepared and kept up to date. However, demonstrating that these responsibilities have been consistently fulfilled can itself become a compliance challenge.
EUDAMED adds another layer of post-market maintenance. As Basic UDI-DIs and UDI-DIs are registered and maintained, Economic Operators must ensure that the information remains accurate. Failure to keep registrations aligned with device updates can result in organisations handling devices whose regulatory information is incomplete or outdated
The article then introduces MDIS (Medical Device Information System) as a response to these challenges. The platform provides secure technical documentation sharing, documented reviews and approvals, PRRC task tracking, UDI-DI-level traceability, and simplified EUDAMED registration. It gives each Economic Operator access to the documentation relevant to its role while maintaining a record of reviews and changes throughout the device lifecycle.
The accompanying Economic Operator flow diagram on page 7 illustrates how manufacturers, PRRCs, Authorised Representatives, Importers, and Distributors can work through a connected workflow leading to EUDAMED registration. The final overview on page 8 contrasts fragmented manual processes with MDIS capabilities such as traceable documentation, automated database registration, UDI-DI traceability, and controlled product release.
Read the original article: MDR & IVDR Regulatory Post-Market Complexities to explore the post-market regulatory complexities of the MDR and IVDR and how MDIS can support Economic Operators in managing them.
