The beginning of 2015 welcomes changes to the EU Commission website for medical devices, as well as new OJEU lists!

Reorganization of EU Commission website

Check your website bookmarks. The EU Commission has recently revised their medical devices website.; the navigation bar is on the left hand side. The guidance documents (including MEDDEVs) are now organized under the topic “Regulatory framework”. There is a category explicitly for the PIP Action Plan.

EN harmonized standards published in OJEU

The list of European Norm (EN) harmonized standards to the medical devices directives have been recently published (16 January 2015) in the Official Journal of European Union (OJEU). On review, there do not appear to be significant revisions from the list published for the Medical Devices Directive MDD 93/42/EEC in May of 2014. However, the OJEU finally includes EN 980:2008 as harmonized for the In Vitro Diagnostic Devices Directive IVDD 98/79/EC as well as Active Implantable Medical Devices Directive AIMDD 90/385/EEC.

Please find the PDFs of the relevant entries published in OJEU: MDD OJEU January 2015 OR see attachment “Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices”

Atlantico continually contribute content to such topics.

We appreciate the opportunity to serve as your European Authorized Representative (EAR) and we look forward to sharing the exciting European developments with you in 2015!