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
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
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.