Medical devices Due to their specific characteristics and potential health risks, they are subject to strict regulation in Germany and in the European Union. The process of placing these products on the market requires compliance with strict compliance, notification and safety monitoring requirements. Below, we outline the key legal aspects related to the introduction of medical devices into the German market.
Legal basis for medical devices
The distribution of medical devices in Germany is regulated by:
- Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (MDR), which sets out requirements for the marketing, market surveillance, advertising and promotion of medical devices in the EU.
- German Medical Devices Act (Medizinprodukterecht-Durchführungsgesetz - MPDG)which implements the MDR at national level.
Procedure for placing a medical device on the market
Before placing a medical device on the EU market, including the German market, the manufacturer or distributor should:
- Ensure product compliance with MDR - For this purpose, a conformity assessment must be carried out, which may include an audit by a notified body.
- Obtain the CE certificate of conformity - for products in a higher risk class, the certificate is issued by a notified body.
- Register the device in the European database EUDAMED - this is required for a product to be legally marketed throughout the European Union.
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Post-market surveillance of a medical device
Once a medical device is placed on the market, the manufacturer should fulfil a number of obligations related to monitoring the safety and compliance of the product.
Post-Market Surveillance (PMS)
It is the systematic post-market monitoring of a product to ensure its continued compliance with safety and efficacy requirements. The purpose of PMS is to identify potential problems that may arise during actual use of the product by consumers, such as unexpected side effects or failures.
Reporting of incidents to supervisory authorities
The medical device manufacturer is required to report any medical incidents or potentially dangerous situations related to the use of the device to the Federal Institute for Drugs and Medical Devices (BfArM) in Germany.
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Update of technical documentation
It is extremely important to regularly update the technical product documentation, including the safety and conformity assessment reports. This is necessary if new product data becomes available.
Consequences of non-compliance of a medical device
If a medical device does not comply with the MDR regulation or national regulations, fines and financial penalties may be imposed on the entity. An immediate withdrawal of the product from the market may also be ordered. The correct implementation of medical devices on the EU market can therefore not be overestimated.
Responsibilities of the producer and the responsible person - summary
The manufacturer and the person responsible for the medical device should:
- Ensure compliance with MDR and national regulations - regularly monitor product compliance with legal requirements.
- Monitor product safety - report any security incidents to the relevant supervisory authorities.
- Keep technical documentation - the documentation must be kept for at least 10 years after the last batch of the product was placed on the market.
- Cooperate with supervisory authorities - the manufacturer and the responsible person must be prepared to cooperate with the supervisory authorities during inspections and audits.
- BfArM in Germany - monitors the medical device market, evaluates incidents and makes safety recommendations.
It is advisable to consult a legal advisor specialised in medical device lawto ensure that all requirements incumbent on manufacturers and distributors are met. The introduction of medical devices into the German market requires careful preparation and compliance with strict legal requirements. Notification to the relevant authorities, compliance with the MDR and continuous market monitoring are key elements to ensure consumer safety and minimise risks for manufacturers.
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