European medical technology trade association Eucomed has issued a new position paper advocating six major changes to how the European Union regulates medical devices.

A new report issued by the US Food and Drug Administration argues that the European Union's regulatory system fails to ensure safety of high-risk medical devices it approves .

A recent investigation by British journalists has brought to light questionable practices by certain European Notified Bodies, prompting greater urgency for medical device regulatory framework revisions proposed in September 2012.

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.

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.

Die Europäische Kommission hat eine inoffizielle Version ihrer regulatorischen Anforderungen für Benannte Stellen veröffentlicht, die eine wesentliche Rolle bei der Erlangung der CE-Kennzeichnung für Medizinprodukte spielen. Obwohl die veröffentlichten Anforderungen keine Referenznummern oder Datumsangaben enthalten, gibt das Dokument klare Hinweise darauf, wie die Benannten Stellen diese Anforderungen einzuhalten zu haben.

The European Parliament has voted in favor of implementing stricter requirements for Notified Bodies , but not for recommended medical device registration reforms that would create an approval process similar to Premarket Approval in the US.

Das Europäische Parlament hat für strengere Auflagen für Benannte Stellen gestimmt, jedoch die Reformempfehlung des Registrierungsverfahrens für Medizinprodukte zur Angleichung an das amerikanische Premarket Approval-Verfahren abgelehnt.

Update September 16, 2014: TGA has corrected its list of Notified Bodies whose certifications will undergo application audits in Australia. The list of affected Notified Bodies has been adjusted for accuracy below.

Die australische Therapeutic Goods Administration (TGA) plant Audits von Zulassungsanträgen (Link auf Englisch) für Medizinprodukte,...