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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.
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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.
The EU has published a draft of a second corrigendum relating to EU Regulation on Medical Devices 2017/745.
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Following the draft bill, the Federal Ministry of Health has now published the cabinet draft for the German EU Medical Devices Adaptation Act (MPEUAnpG).
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EU: Additional notified bodies for the MDR announced
The EU has published two new notified bodies for the MDR in the Nando database. These additions mean that there are now seven notified bodies available for the MDR.
According to information on its website, the EU is postponing the launch of the EUDAMED database until May 2022. The date on which the MDR becomes valid in May 2020 remains unchanged.
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