Who is responsible for compliance with the regulatory provisions?
With the possibility of registering in EUDAMED , the question also arises as to who is responsible for compliance with the regulatory provisions "Responsible Person" according to MDR Article 15 or "Responsible Person" (VP/PRRC) for short.
Diese Funktion muss nur bei Hersteller*innen und EU-Bevollmächtigten bereitgestellt werden. Importers do not need to provide it. From a German perspective, the Responsible Person/PRRC (Person Responsible for Regulatory Compliance) eplaces the safety officer from the past, even if the rights and duties are not transferable on a one-to-one basis. Especially in smaller companies, there is often a lack of a person with the necessary requirements of a responsible person.
The required expertise must be documented as follows in accordance with the MDR , :
- (a) Diploma, certificate or other evidence of formal qualification by completion of a university degree or a course of study recognised as equivalent by the Member State concerned in law, medicine, pharmacy, engineering or another relevant scientific discipline and at least one year of professional experience in regulatory affairs or quality management systems related to medical devices;
or
- b) four years of professional experience in regulatory affairs or quality management systems related to medical devices.
In order not to jeopardise the company's continued existence as a medical technology company, external managers may be used. As the title suggests, this entails a great deal of responsibility. In our opinion, blind trust is not sufficient to take action here.
All of this is for your own protection, as there is no reassurance from the notified body, especially for Class I products.
If you would like to know more details about the person responsible, please do not hesitate to contact us..
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