This post is based on the Impact of the Draft report on the EU MDD proposed regulations and comes from posts, opinion pieces and stories from MedTech Europe, Eucomed & Erik Vollebregt (medicaldeviceslegal.com) If you are reading this post my guess
NB-MED issues FAQ on Implementation of EN62304:2006 w.r.t. MDD, V1.0
18 April 2013 – The NB-MED EN62304:2006 issues team released their first official version (V1.0) dated 5 April 2013 of this importnat implementation document in regards to EN 62304 with respect to the Medical Device Directive 93/42/EEC on the NB-MED website. EN
EU Team-NB adopted V3.0 Code of Conduct – Align to Recent Proposed Regulations
On 10 Oct 2012 The European Association for Medical devices of Notified Bodies (better known as Team-NB) issued a press release on the adoption of Version 3.0 of the Code of Conduct (CoC) for Notified Bodies under Directives 90/385/EEC (Active
EU Competent Authorities formed Central Management Committee (CMC) & Issued Decisions
The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther, and many thanks to NSAI the Irish Notified Body: The European Competent Authorities have formed a Central Management Committee (CMC) to achieve greater consistency in the
RoHS Recast Implications to EU Med & IVD Devices
The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther: The recast of the Restriction of Hazardous Substances (RoHS) Directive has been released as 2011/65/EU. You can read the directive at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:EN:PDF. With the exception of