Medical Devices EU Adaptation Act

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Basic data
Title: Act to adapt medical device law to Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Short title: Medical Devices EU Adaptation Act
Abbreviation: MPEUAnpG
Type: Federal law
Scope: Federal Republic of Germany
Legal matter: Medical law
Issued on: April 28, 2020 ( Federal Law Gazette I p. 960 )
Entry into force on: April 24, 2020 to May 26, 2022 (Art. 17 G of April 28, 2020)
Last change by: Art. 15 G of 19 May 2020 ( Federal Law Gazette I p. 1018 )
GESTA : M030
Weblink: Text of the law
Please note the note on the applicable legal version.

The Medical Devices EU Adaptation Act is a law that serves to adapt national medical device law to Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostics .

The MPEUAnpG comprises 29 articles. Art. 1 contains the new Medical Device Law Implementation Act , which will replace most of the provisions of the Medical Devices Act (MPG) on May 26, 2021 . A major change for Germany is the redesign of the distribution of competencies between the federal government and the federal states, in particular with regard to the arrangement and implementation of measures in the event of conspicuous risk assessment by a "central body."

Articles 2 to 16a contain amendments to other laws. Art. 17 regulates the entry into force and expiry.

content

  • Article 2 Amendment of the Medical Device Law Implementation Act
  • Article 3 Further amendments to the Medical Device Law Implementation Act
  • Article 4 Amendment of Book Five of the Social Code
  • Article 4a Amendment of the Federal Aid Ordinance
  • Article 5 Amendment of the Law on Advertising for Medicinal Products
  • Article 6 Further amendments to the Law on Advertising for Medicinal Products
  • Article 7 Amendment of the Medicines Act
  • Article 8 Further amendments to the Medicines Act
  • Article 9 Amendment of the Food and Feed Code
  • Article 9a Amendment of the law on protection against non-ionizing radiation when used on humans
  • Article 10 Further amendments to the Food and Feed Code
  • Article 10a Amendment of the Hospital Financing Act
  • Article 10b Amendment of the Electrical and Electronic Equipment Ordinance
  • Article 10c Further amendments to the Electrical and Electronic Equipment Ordinance
  • Article 11 Amendment of the Electrical and Electronic Equipment Act
  • Article 11a Amendment of the Medical Device Safety Plan Ordinance
  • Article 11b Amendment of the ordinance on clinical trials of medical devices
  • Article 12 Further amendments to the Electrical and Electronic Equipment Act
  • Article 12a Amendment of the Implant Register Act
  • Article 12b Modification of the Measurement and Verification Ordinance
  • Article 13 Amendment of the Chemicals Act
  • Art. 14 Further amendments to the Chemicals Act
  • Art. 15 Changes to the Product Safety Act
  • Art. 16 Further changes to the Product Safety Act
  • Article 16a Further changes due to the dissolution of the German Institute for Medical Documentation and Information
  • Article 17 Entry into force, expiry

Web links

Individual evidence

  1. ↑ Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83 / EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing directives 90/385 / EEC and 93/42 / EEC of the Council ABl. L 117/1 of May 5, 2017.
  2. ↑ Regulation of the European Parliament and of the Council of April 5, 2017 on in-vitro diagnostic medical devices and repealing Directive 98/79 / EC and Commission Decision 2010/227 / EU OJ. L 117/176 of 5 May 2017.
  3. ↑ Medical Devices EU Adaptation Act AOK Federal Association , accessed on June 1, 2020.