이머고 핵심 요약: 유럽 연합과 영국 협상 교섭단체 사이에 브렉시트 협정 초안이 계류되고 있습니다. 인증기관은 전환 기간 동안 허가된 상태일 것입니다. 이 협정이 통과될지 여부는 확실하지 않습니다. 브렉시트의 갑작스러운 절벽도 하나의 가능성으로 남아있습니다.

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.

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.

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 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.

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.

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.

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 .

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