MEDDEV 2_7_2_rev2 Guidelines for Competent Authorities for making a validation-assessment of a clinical investigation application under directivesTélécharger
MEDDEV 2_7_4_en Guidelines on Clinical investigations- a guide for manufacturers and notified bodiesTélécharger
MEDDEV 2_7_3_rev_3_2015_en Clinical investigations- serious adverse reporting under directivesTélécharger
MDCG Guidances :
European Commission Guidance :
The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations : link to European Commission Guidance
PRRC Booklet from SNITEM (in French) :
CAMD FAQ – MDR Transitional provisions :
COMMON SPECIFICATIONS :
COMMISSION IMPLEMENTING REGULATION (EU) 2020/1207 of 19 August 2020 as regards common specifications for the reprocessing
of single-use devicesTélécharger
of single-use devicesTélécharger