If you are not a small company, you might ask yourself: “Shouldn’t we have already a responsible person for regulatory compliance?” Answer is “no”. All medical device manufacturers have quality teams but MDR wants us to have a person experienced in the field of medical devices. This person is going to be legally responsible under the law. In addition, this person must have some qualifications. In this article, we’ll try to explaint to you “MDR Article 15 Person Responsible” and his/her qualifications.
For the full regulation please click here.
A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of 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 in quality management systems relating to medical devices;
or
Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
In accordance with Article 15 of the European Parliament and Council Regulation (EU) No 2017/745 (MDR), the person responsible for regulatory compliance shall at least be responsible for ensuring that:
Are you small / micro company?
If you are micro and small enterprise, you shouldn’t be required to have the person responsible for regulatory compliance within your organization. But…. you should have such person permanently and continuously at your disposal.
Although the regulation does not explicitly state the need to make a contract with your own staff, it is still useful to make a contract.
Here you cand find the “Employment Contract” for your Person Responsible for Regulatory Compliance. Please click here to download “Word” version of the contract below.
If you have a number of persons are jointly responsible for regulatory compliance, in their respective areas of responsibility should be stipulated in writing. Which means you should state these responsibilites in a written text somewhere.
Whether or not he/she is a a employee of your company, he/she should fufill properly his or her duties as it should be.
If you are a Non-EU manufacturer, your Authorized Representative should have its own Person Responsible for Regulatory Compliance in the Union.
Click here for the article “MDR Article 11 Authorized Representative “
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