Eucomed Proposed EU Regulatory Fixes

European medical technology trade association Eucomed has issued a new position paper advocating six major changes to how the European Union regulates medical devices.

First, Eucomed argues for tighter control and monitoring of Notified Bodies across the EU. Precise and mandatory Notified Body designation requirements, EU-wide accreditation standards for Notified Bodies, and better Competent Authority control over Notified Bodies are prescribed, as well as joint auditing of Notified Bodies by both Competent Authorities and the European Commission.

Second, a single European approach to vigilance and surveillance should be established in order to foster a more uniform level of health protection across member states. Eucomed recommends a more well-defined legal framework for handling vigilance as well as a centralized reporting and surveillance infrastructure used by all EU member states for exchanging device information.

Third, all EU Competent Authorities should adhere more closely to harmonized standards, according to Eucomed, and participate more directly in the development of such standards in order to address mounting implementation issues in European markets.

Consistent implementation of guidelines, Eucomed's fourth recommendation, entails revising existing procedures for developing guidelines in order to commit member states to uniformly put them in place. In addition, the European Commission’s Medical Device Expert Group should be upgraded from a voluntary to a formal advisory committee in order to establish and manage a more consistent guideline development process.

Fifth, European regulators should increase transparency regarding the Medical Devices Directives' confidentiality requirements. Eucomed argues that such lack of transparency has undermined public trust in the EU regulatory system and CE marking process. This issue should be remedied by setting up a central EU database at least partially available to the public; the database should include information on devices available on the European market, registration of economic operators, vigilance and market surveillance data, and clinical investigations.

Finally, better coordination and management among European regulators is necessary in order to ensure uniform application of requirements across all member states. To achieve this goal, Eucomed suggests the following steps:

  • Auditing Notified Bodies for quality
  • Coordination of vigilance reporting systems and practices
  • More “horizon scanning” to deal with potential EU health challenges
  • Providing expert policy advice regarding medical technology to drive evidence-based decisions and legislation among regulators
  • Providing sound scientific advice to member states and European Commission personnel

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