Eucomed’s six steps to better medical device regulation

 Industry association Eucomed has proposed a new unified regulatory framework for medical devices across Europe.

The association’s position paper outlines six steps that will ensure patients have rapid access to innovative medical technologies that are value-based and safe.

Consistency, transparency and an integrated approach are the key themes identified by Eucomed as being in the shared interest of industry, healthcare providers and patients.

Eucomed’s position paper ‘A new EU regulatory framework for medical devices’ calls for enhanced member state engagement together with unified and science-based co-ordination of the regulatory system.

While prioritising delivery of high-quality healthcare, patient safety and rapid access to value-based medical technologies, the proposals also aim to encourage R&D and reduce the administrative burden on SMEs.

The association calls for a legal framework to provide a unified regulatory approach to the evaluation and certification of medical devices, with consistent and comprehensive implementation across all EU member states.

Existing bodies such as the European Commission, Competent Authorities and Notified Bodies can be used efficiently to provide a ‘smarter’ legal framework for medical devices, Eucomed says.

The six steps outlined are:

1. Only the best Notified Bodies – better control and monitoring of NBs are needed, including mandatory requirements for designation.

2. A single approach to vigilance and market surveillance – with a centralised reporting and surveillance system based on an EU portal.

3. Stronger harmonised standards – with greater engagement of international experts and earlier involvement of member states.

4. Consistent implementation of guidelines – to make medical device guidance more efficient and consistent across the EU, the current procedure must be revised (e.g. by commitment of member states to uniform implementation) and the European Commission’s current Medical Devices Expert Group (MDEG), which develops guidance, must be upgraded to a formal Advisory Committee.

5. Improved transparency – for better access to information for patients, consumers, healthcare professionals and manufacturers as well as regulatory and legislative bodies, it is critically important to establish a single EU database with information relating to such areas as market surveillance, vigilance and what products are available.

6. An integrated approach – better co-ordination and management, which could be supported by the Commission’s DG SANCO and Joint Research Centre (JRC). The JRC could play a crucial role in such areas as auditing Notified Bodies, co-ordinating vigilance, providing foresight intelligence on health issues, and giving scientific and policy advice to legislators.

John Brennan, Eucomed’s Director of Regulatory and Technical Affairs, commented: “By improving the regulatory framework for medical devices through the six solutions outlined in our position paper, we believe Europe will become stronger in many areas. We suggest many improvements that aid better management of the system by authorities and the Commission.

“In achieving this we think that the JRC is the natural partner for DG SANCO, member states and industry to shape and drive a smart EU medical technology legislative framework, as it is independent and experienced in the broad range of technologies that reflect the medical device industry.”