ACIG

ENGLISH 23 nal legislative acts need to be considered in Germany going forward: 1. The Medical Devices EU Amendment Act (Medizinprodukte-EU-Anpassungsge- setz, MPEUAnpG) - draft legislation passed by Germany’s lower house of parli- ament, the Bundestag, on 05. March 2020 2. The Medical Devices Implementation Act (Medizinprodukte-Durchführungsge- setz, MPDG) and further legislative amendments (described in MPAnpG-EU) The Medical Devices Amendment Act EU (MPEUAnpG) is designed to adapt the Ger- man Medical Devices Act (Medizinproduktegesetz, MPG) to the EU requirements that will then apply, i.e. primarily those set out in Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. These regulations together replace the three EU directives (90/385/EEC, 93/42/EEC, 98/79/EC) from the 1990s following transitional periods of 3 (medical devices) and 5 (in vitro diagnostic medical devices) years respectively. Corrigendum II to Art. 120(3) MDR The MDR was supposed to finally enter into force in May of 2020. As mentioned above, the appointed time has now been postponed by one year. Relief for ma- nufacturers of class I devices has, however, already come in the form of the 2nd Corrigendum to the MDR (from 25. November 2019). The original Article 120(3) [old version] “By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with either of those Directives, and ...” ... now reads: Art. 120(3) [as amended] “By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment pro- cedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 it continues to comply with either of those Directives, and ...”