Tag: Responsible person

Novelty of the medical device Regulation proposal concerning Responsible Person

According to Article 13 of the draft medical device Regulation entitled “Person responsible for regulatory compliance” as lastly amended by the European Parliament, “manufacturers must have available within their organization at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices”. Hence, the main change in medical device Regulation proposal is the requirement that a qualified person of manufacturer’s organization or authorized representative should be responsible for regulatory compliance.

Interestingly, professional experience can replace an academic qualification. In contrast to the requirements for the qualified person for medicinal products, the responsible person for medical devices can rely on either a diploma or a professional experience. Moreover, this amendment of the  European Parliament enables that the role and responsibilities may be shared between several persons responsible for example for one of these tasks: regulatory, production or quality assurance compliance.

More on the topic you can read here and here

MedTech Europe help for Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union

The “Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union” …

KOMUNIKAT KOMISJI Wytyczne w sprawie przyjęcia odstępstw ogólnounijnych dotyczących wyrobów medycznych zgodnie z art. 59 rozporządzenia (UE) 2017/745

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EMA warns against using unproven cell-based therapies

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