Oct 10, 2011

As usual, the only thing that stays the same in the EU regulatory system is constant change, and this summer has been no exception. In addition to a few minor updates, there have been developments that could shake the very foundation of the EU regulatory system. Salacious, indeed.

New/Updated Standards Published to the OJEC

An updated list of standards (considered European norm harmonized to the directives) was published in the Official Journal of European Communities (OJEC) on August 19, 2011. Each directive has a corresponding list of applicable standards. Of particular interest are standards on the MDD, IVDD, and AIMDD.

Notably, a new series on of standards on aseptic processing of healthcare products (EN ISO 13408-2:201) has been included.

The European Commission had objected to a total of 11 European harmonized standards, including the seminal EN ISO 14971 risk management standard and this was followed in mid-February by the Swedish authorities questioning whether EN ISO 13485:2003—the quality system standard for medical devices—was sufficient . We have also become aware that another Competent Authority is challenging these standards and compliance as appropriate for a presumption of compliance.

Given that these standards represent cornerstones of the European medical device regulatory system, a hot debate has ensued. Indeed, the release of EN ISO 14155:2011 as an EN harmonized standards, published in OJEC is mired in this dispute.

Manual on Borderline and Classification, Version 1.10

The European Commission has issued a new version of the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices, Version 1.10 was published in March 2011 on the European Commission website. The new version is available from the Emergo Group Learning Library.

New sections in this version include assessments of Gallipots, antimicrobial wound irrigation solutions, and contact lenses.

As a point of interest on borderline product evaluation, in addition to the EU Experts Working Group, many competent authorities maintain their own borderline manuals separately. As an example, the MHRA has a borderline section on their website addressing medical device/medicinal borderline products and others. These, of course, are not as authoritative as the MEDDEV on Classification or the EU Manual on Borderline products, but can nonetheless serve as a valuable additional resource.


A meeting titled Recast of the Medical Devices Directive, 16 September 2011, has provided comments by the EU Commission about the recast. We hope to have access to the transcript of the meeting in the near future.

Council Conclusions on Innovation in the Medical Device Sector

We reported previously (in June 2011) on the EU Council conclusions on medical device innovation. This has now been published in the OJEC, August 7, 2011 issue.


  • Stewart Eisenhart