Search results with tag "Medical device directive"
General Safety and Performance Requirements (Annex I) in ...
www.bsigroup.comDevice Directive (MDD, 93/42/EEC) and Active Implantable Medical Device Directive (AIMDD, 90/385/EEC), so too is compliance with the ‘General Safety and Performance Requirements (SPRs)’ in establishing conformity with the recently published Medical Device Regulation – EU Regulation 2017/745 (MDR). The Regulation’s date of publication
Guideline on the quality requirements for drug-device ...
www.ema.europa.eu130 repeals Directive 93/42/EEC (the Medical Device Directive, MDD). 131 In addition, this guideline should be read in conjunction with all other relevant directives and 132 regulations, the European Pharmacopeia and all relevant Commission, ICH and CHMP guidelines, Q&A
Medical Device Directive (MDD)
www.medicaldevicesgroup.netThere are four device classifications: – Class I – Class IIa – Class IIb – Class III. Class I devices, that are non- sterile and non-measuring, do not require a Notified Body (NB). All other products require NB involvement. Annex IX of the MDD defines the classification rules for Europe. There is also a guidance document, MEDDEV 2.4/1