New European MEDDEV guidance on clinical evaluation

Directive 2007/47/EC which modifies the Medical Devices Directive MDD 93/42/EEC (and AIMDD 90/385/EEC) becomes effective on March 21, 2010. The new Directive includes a definition for clinical data and further enhances the clinical evaluation report expectations of MDD 93/42/EEC, Annex X. To this end, the European Commission recently published two guidelines (MEDDEV documents) related to clinical data.

Appendix 1 of MEDDEV 2.7.1 - December 2008

Clinical Evaluation of Coronary Stents

Appendix 1 is an addition to MEDDEV 2.7.1 entitled "Evaluation of Clinical Data: A Guide for Manufacturers and Notified Bodies." It is replete with guidance on coronary stents including: guidance references, applicable standards, preclinical assessment, clinical investigation design, development, assessment, literature review, and post marketing clinical follow-up.

The document discusses the "main requirements for the clinical evaluation of coronary stents based on current state-of-the-art and on experience drawn from the most recent reviews of clinical studies." As an example, the following are recommended in the preclinical assessment section of the Design Dossier: biocompatibility testing (EN ISO 10993), bench testing (EN 14299), and animal studies (EN 14299, EN ISO 14630, EN 12006-3).

MEDDEV 2.7.2 - December 2008

Guide for Competent Authorities in Making an Assessment of Clinical Investigation Notification

MEDDEV 2.7.2, is provided to assist Competent Authorities in similarly reviewing clinical investigation notifications (Article 15, MDD 93/42/EEC). The guidance is essentially a five page checklist of items that should be provided in the clinical investigation notification that is harmonized to EN ISO 14155. Note, EN ISO 14155, Parts 1 and 2, are in the process of being revised.