02 beo en quali pers

The German Medical Devices Act (Medizinprodutgesetz – MPG) obliges producers/distributors of medical devices or their Authorized European Representative to appoint a safety Manager (§ 30). The safety manager for medical devices has to collect information about medical device risks. He also has to assess and coordinate the necessary actions and is responsible for the fulfilment of medical-risk related reporting obligations.

The appointment of a safety officer is a purely national requirement of the German Medical Devices Act. It is applicable to all responsible persons which are based in Germany when they introduce their product to the German market.

Responsible person according to § 5 MPG is

  • the manufacturer
  • the Authorized European Representative – based in Germany - for a manufacturer outside the European Union, or
  • the importer – based in Germany - if no Authorized European Representative is appointed

The company has to ensure that the safety manager receives information about new "medical risks" on time, complete and in the original version. The safety manager is responsible to comply with the medical-risk reporting duty to the competent authority. At the moment of first time market entry, the responsible person (for example, the manufacturer) is obliged to immediately inform the competent authority about name and address of the safety manager. Any change in the function of the safety manager has to be also immediately notified to the competent authority, without delay.

As a safety manager, only a person can be appointed who has at least two years of professional experience in the medical device field. The proof of the required expertise as safety manager for medical devices can be a certificate of a completed scientific, medical or technical college training or other training, which qualifies them for the tasks referred to in § 30 (MPG).

Many companies are overwhelmed by the requirement of this responsible task. At seminars, we provide basic knowledge on the safety managers and provide information on documentation requirements for medical devices. As we possess the required expertise and knowledge, you can choose BEO BERLIN® to be your safety manager, too.

Qualified Person

  • Registration by name
  • Contact person for authorities
  • Annual medical product risk assessment
  • Incident handling
  • Necessary procedure coordination
  • Disclosure requirement fulfilment
  • Public audit supervision

 

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