European Union member states should take immediate steps to

The European Commission has published an unofficial version of its new regulatory requirements for Notified Bodies that play a key role in CE Mark certification for medical devices. Although the published requirements contain no reference numbers or dates, the document likely provides a clear indication of how Notified Bodies will have to comply.

Das Europäische Parlament hat eine Antwort (Dokument auf Englisch) auf die von der EU-Kommission vorgeschlagenen Gesetzesänderungen für den europäischen Medizinproduktemarkt veröffentlicht.

The European Union Parliament has recently published a draft response to EU Commission proposed legislative changes for the European medical device market.

Der deutsche Bundesverband Medizintechnologien (BVMed), die größte Handelsgruppe Deutschlands in der Medizinprodukte-Branche, hat die Umsetzung von Sofortmaßnahmen von der Europäischen Kommission gefordert, um die Überwachung von Benannten Stellen und die Kontrolle von Medizinprodukten nach der Markteinführung zu verbessern.

The German Medical Technology Association (BVMed), Germany's largest medical device industry trade group, has urged...

In addition to recent draft regulations concerning medical devices and in vitro diagnostics, the European Commission has drafted additional reforms (“PIP Action Plan”) aimed specifically at greater control of Notified Bodies. The draft Regulation on Designation and Supervision of Notified Bodies and Recommendations for Audits and Assessments have been drawn-up by means of the Standing Committee-mechanism described in Article 7 of the MDD 93/42/EEC (and Article 6 of the AIMDD 90/385/EEC). Therefore, these changes are expected much sooner than the impending legislative revisions. The Commission documents are expected to be released before the end of 2012 and the changes will likely be implemented as soon as 2013.

De Europese Commissie heeft het volgende persbericht uitgegeven naar aanleiding van voorstellen voor twee nieuwe...

Final publication of the European Commission’s regulations covering electronic instructions for

EC sets parameters of expert panel component of MDR, IVDR