The Medical Device Regulation and its impact on device development and research in Germany

Author:

Ladd Mark E.

Publisher

Elsevier BV

Subject

Radiology, Nuclear Medicine and imaging,Radiological and Ultrasound Technology,Biophysics

Reference21 articles.

1. REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices [Internet]. 2017. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745.

2. COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices [Internet]. 1993. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31993L0042.

3. COUNCIL DIRECTIVE 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices [Internet]. 1990. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:01990L0385-20071011.

4. Gesetz zur Durchführung unionsrechtlicher Vorschriften betreffend Medizinprodukte (Medizinprodukterecht-Durchführungsgesetz - MPDG) [Internet]. 2020. Available from: https://www.gesetze-im-internet.de/mpdg/MPDG.pdf.

5. Ongoing problems with metal-on-metal hip implants;Heneghan;BMJ,2012

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