Tasks
According to the Act on Medical Devices (MPG) and further ordinances, the Federal Institute for Drugs and Medical Devices (BfArM) is responsible for the following tasks:
1. Central collection, analysis and evaluation of risks
The Federal Institute ensures the central collection, analysis and evaluation of risks arising from the use or application of medical devices, in particular, adverse effects, interactions with other substances or products, contra- indications, falsifications, operational defects, malfunctions and technical defects and in so far co-ordinates the necessary measures to be taken especially as regards the following incidents:
a.) any malfunction, any failure or deterioration in the characteristics or performance of a medical device as well as any inaccuracy in the labelling or instructions for use which has led, or could have led, directly or indirectly, to the death or serious deterioration in the state of health of a patient or user or another person,
b.) any technical or medical reason which, as a result of the causes mentioned in (a.), is related to the characteristics and performance of the medical device and has led to the systematic recall of medical devices of the same type by the manufacturer.
In fulfilling these tasks, the Federal Institute for Drugs and Medical Devices collaborates with the authorities of the other States Party to the Agreement on the European Economic Area, and the Commission of the European Communities, the World Health Organization, the authorities of other countries responsible for public health as well as occupational safety and health, the authorities of the Laender responsible for public health, occupational safety and health, radiation protection, and metrology and other higher federal authorities which are concerned from a technical viewpoint, Notified Bodies in Germany, the competent occupational accident insurance funds, the medical advisory service of social health insurance, the pertinent professional societies, the manufacturers and distributors, as well as other bodies which compile data on risks associated with medical devices in the fulfilment of their tasks. If any incident is suspected to have been caused by an electromagnetic interaction with any device other than a medical device, then the Federal Office for Posts and Telecommunications shall be involved.
2. Authorisation of medical devices
The Federal Institute may for a limited period of time authorise, on duly justified application, the first placing on the market or putting into service in Germany, of individual medical devices if their use is in the interest of protection of health
3. Registration of Ethics committees
4. Providing advice to the responsible Laender authorities in questions of classification of medical devices and the demarcation of medical devices from other devices
5. Providing advice to the competent authorities and Notified Bodies with regard to technical, medical and safety requirements for medical devices
6. Collaboration in national, European and international working groups including standards committees
The scope of the competences of the higher federal authorities in Germany
- The Federal Institute for Drugs and Medical Devices is responsible for the evaluation regarding the technical and medical requirements and the safety of medical devices, unless otherwise provided for in the present Act or unless competence lies with other higher federal authorities, and shall advise the competent authorities and Notified Bodies.
- The Paul Ehrlich Institute is responsible for the tasks contained in paragraph 1, in so far as in vitro diagnostic medical devices mentioned in Annex II to Directive 98/79/EC are concerned which are intended for testing the safety or compatibility of blood or tissue donations or are related to infectious diseases. A technically independent testing laboratory can be set up at the Paul Ehrlich Institute which can collaborate with the Notified Bodies and other organisations.
- The Physikalisch-Technische Bundesanstalt is responsible for ensuring the uniformity of metrology in medicine.