Medical Device Law Implementation Act
| Basic data | |
|---|---|
| Title: | Law for the implementation of EU regulations regarding medical devices |
| Short title: | Medical Device Law Implementation Act |
| Abbreviation: | MPDG |
| Type: | Federal law |
| Scope: | Federal Republic of Germany |
| Legal matter: | Commercial administrative law |
| References : | 7102-52 |
| Issued on: | April 28, 2020 ( Federal Law Gazette I p. 960 ) |
| Entry into force on: | predominantly May 26, 2021 Art. 15 G of May 19, 2020 ( BGBl. I p. 1018, 1034 ) |
| Last change by: |
Art. 3 G of April 28, 2020 ( Federal Law Gazette I p. 960, 993 ) |
| Effective date of the last change: |
May 26, 2022 (Art. 18 G of April 28, 2020) |
| GESTA : | M030 |
| Weblink: | Text of the law |
| Please note the note on the applicable legal version. | |
The Medical Device Law Implementation Act (MPDG) serves to implement and supplement Regulation (EU) 2017/745 . It was introduced by Article 1 of the Medical Devices EU Adaptation Act of April 28, 2020 ( Federal Law Gazette I p. 960 ).
In Germany, the MPDG will gradually replace the Medical Devices Act for all products within the scope of the regulation from May 26, 2021 . For in-vitro diagnostics, the Medical Devices Act is still to be applied temporarily until May 25, 2022 ( Section 2 (1) MPDG). Thereafter, the scope of the Medical Device Implementation Act will also be extended to in-vitro diagnostics.
