European Commission Publishes Results of the Second Survey of Economic Operators: Key Takeaways for Medical Device Manufacturers

The European Commission has released the results of its second survey of Economic Operators, assessing how manufacturers, authorised representatives, importers and distributors are adapting to the requirements of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The survey aims to understand the regulatory impact on businesses and identify challenges linked to compliance, resources, and market readiness.
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The questionnaire evaluated several areas: the role of economic operators, experience with MDR/IVDR implementation, operational and financial burden, data reporting practices, and perceived obstacles in meeting regulatory obligations.

Impact on Manufacturers

1. Increased resource and compliance burden

The survey highlights that many manufacturers face a significant administrative load, with challenges linked to documentation, reporting obligations, and coordination with other economic operators.

2. Complexity in fulfilling MDR/IVDR responsibilities

Manufacturers report difficulties in ensuring full compliance with post-market surveillance, vigilance reporting, traceability, and UDI requirements. The results reflect a global need for clearer guidance and harmonised expectations.

3. Supply chain coordination issues

The findings indicate persistent misalignment between manufacturers, authorised representatives, importers and distributors, particularly regarding information flows and verification duties.

4. Strategic challenges for smaller manufacturers

SMEs report disproportionate challenges compared to larger companies, particularly in areas requiring significant regulatory resources (technical documentation, PMS, PRRC obligations).

5. Need for streamlined regulatory processes

Feedback collected by the Commission suggests that manufacturers desire:

• greater regulatory clarity,

• more consistent expectations among Member States,

• improved transparency,

• and reduced administrative burden.

The results of this second survey provide valuable insights into the operational and regulatory pressures faced by manufacturers across the EU. The Commission will use these findings to inform future regulatory initiatives and potential simplification efforts under the MDR/IVDR framework.

The full survey document is available for download below.