Legislation, National Authorities and Institutions
The placing on the market of a medical device as well as its operation requires a constant adherence of various regulatory requirements. So far, the three EU Directives 90/385/EEC on active implantable medical devices, 93/42/EEC on medical devices and 98/79/EC on in vitro diagnostic medical devices have formed the basis for national legislation.
In 2017, the three above mentioned EU directives were replaced by two EU regulations:
- EU-regulation 2017/745 for Medical Devices
- EU-regulation 2017/746 for In vitro Diagnostic medical devices
The new EU regulations are to be applied after a three-year transitional period for medical devices and after a five-year transitional period for in vitro diagnostic medical devices.
Standards play an important role during the demonstration of compliance with the essential safety and performance requirements. Standards that the European Commission has assessed as suitable in this function are listed as harmonized standards in the Official Journal of the EU. Currently, the Official Journal of the EU only lists standards for the above-mentioned EU directives on medical devices. For the drafting of standards in support of the new. EU regulations, the standardization requests of the European Commission are still pending
The platform ‘Medizinprodukte Europa’ offers you a collection of harmonized standards on the basis of the relevant DIN standards, including the legal framework
Furthermore, standards for medicine and health care also play an important role in connection with "purely" national legislation.
- Citation of standards on the reprocessing of medical devices in the Joint Recommendation of the Commission for Hospital Hygiene and Infection Prevention and the BfArM on the "Requirements for hygiene in the reprocessing of medical devices" You can find this recommendation in the Medical Device Operator Ordinance (MedPBetreibV), § 8, Preparation of Medical Devices.
- Definition and evaluation of standards for IT systems and devices within the project "vesta" of the Gesellschaft für Telematikanwendungen der Gesundheitskarte mbH (gematik). The project vesta results from the law for secure digital communication and applications in health care (e-health law), which stipulates the introduction of the digital infrastructure and the implementation of beneficial applications on the electronic health card while adhering to high security standards.
The following list includes the national authorities and institutions that are largely responsible for the placing of medical devices on the market, for their operation as well as for certification and accreditation.
- The Bundesministerium für Gesundheit (BMG) and the following authorities within the scope of the BMG
Federal Institute for Drugs and Medical Devices (BfArM)
Robert Koch Institut (RKI)
German Institute of Medical Documentation and Information (DIMDI)
Bundeszentrale für gesundheitliche Aufklärung (BZgA)
- Physikalisch-Technische Bundesanstalt (PTB)
- Bundesamt für Strahlenschutz (BfS)
- Bundesinstituts für Risikobewertung (BfR)
- Federal Office for International Security (BSI)
- Deutsche Akkreditierungsstelle (DAkkS)
- Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG)
- Zentralstelle der Länder für Sicherheitstechnik (ZLS)