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EU: Documents on European Medical Device Nomenclature (EMDN) published

The EU has published two documents on the new European nomenclature for medical devices that is to be introduced: A brief opinion regarding EMDN and a document on the principle of the underlying Italian CND nomenclature.

The MDCG has published new guidance on cybersecurity with respect to medical devices in the form of MDCG 2019-16.

On 27th December 2019, the EU published the second corrigendum relating to the MDR and IVDR in the Official Journal of the EU.

EU: Additional bodies announced for the MDR and IVDR

MEDCERT, a body for the MDR, and BSI Group The Netherlands B.V., a body for the IVDR, are the two newest notified bodies. With these new additions, there are now nine notified bodies available for the MDR and three for the IVDR.

EU: Guidance for Class I manufacturers published

The MDCG has published MDCG 2019-15, a guidance document for manufacturers of Class I products; it provides a step-by-step guide to the required tasks for placing a Class I medical device on the European market.

Germany: Implant register law published in the German Federal Law Gazette

The law on the creation of the implant register was published in the German Federal Law Gazette on 17th December 2019. This hereby introduces the German Law on the Implant Register (IRegG). Its date of application is 1st January 2020.

The EU has published two additional guidance documents in the form of MDCG 2019-13 and MDCG 2019-14.

EU: Additional notified bodies for the MDR

On 14th December 2019, DEKRA Certification B.V. was entered into the Nando database as the eighth notified body for the MDR.