E-update - 24 January 2013
The first MDEG meeting of 2013 was held recently in Brussels attended partially by Gert Bos, BSI, as representative of TEAM-NB association of EU Notified Bodies. Among items discussed at the meeting were:
- MEDDEV 2.12-1, Guidelines on a Medical Devices Vigilance System, rev. 8 – Final version has been adopted and is expected to be published on EC website soon with 6 month transition period.
- Revision of MDD, AIMDD and of the IVD Directive – Adoption during the first half of 2013 is being pursued as a possibility by some EU Member States, with a view to finalize the revisions before the parliamentary re-elections in summer 2014.
- Unannounced Visits by Notified Bodies – Many EU Member States are waiting for European Commission guidance before requiring Notified Body’s to introduce as a routine activity. Such recommendation is anticipated to be published at the time the new Implementing Regulation on designation of Notified Bodies will be adopted later this year.
- EU Scientific Committee – Opinions being formulated regarding PIP breast implant case, mercury in dental amalgam, metal-on-metal joint replacements, bishenol-A and nano materials; increasing activities to prepare for more structured opinions as foreseen in current draft legislation.
- Eudamed Working Group – Version 3 is being planned to address the Europe databank requirements of the proposed medical device regulations and defining levels of access for all types of stakeholders.
- IMDRF – Reports on the various work groups and work item.
- Mutual Recognition Agreement between EU and Australia – Transition of the new MRA timetable and implications.
- Global Medical Device Nomenclature – Policy Advisory Group reports back on procedural and revision concerns.
As information is ready to release on the above topics BSI will issue further email updates as appropriate. If you have any questions, please email us at firstname.lastname@example.org.