QP for Manufacturers of Medical Devices - New EU Requirement?

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12-14 December 2023

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- Stability Testing in Product Design and Method Development- Focus mainly on small-molecule APIs and drug products

In the previous news in this newsletter we reported on the EU proposals concerning the regulatory framework for medical devices and in vitro diagnostic medical devices in the form of proposals for two regulations. Regarding medical devices, article 13 of the proposal introduces a new role for manufacturers of medical devices: A person responsible for regulatory compliance, subsequently referred to as "qualified person".

Article 13 requires manufacturers to have available within their organisation at least one qualified person who possesses expert knowledge in the field of medical devices. How is this expert knowledge to be accounted for? Article 13 also imposes requirements concerning this question:

• An university degree or a degree of an equivalent course of study, in natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to medical devices;

or

• five years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

Regarding the first point, an exception is made for manufacturers of custom-made devices.

The proposal also defines that the qualified person is responsible for ensuring:

• that the conformity of the devices is appropriately assessed before a batch is released;  
• that the technical documentation and the declaration of conformity are drawn up and kept up-to-date;  
• that the reporting obligations in accordance with Articles 61 to 66 (vigilance) are fulfilled;  
• in the case of investigational devices, that the statement referred to in point 4.1 of Chapter II of Annex XIV is issued.

It is mentioned expressly that the qualified person shall suffer no disadvantage within the manufacturer's organisation in relation to his duties. Authorised representatives shall have available within their organisation at least one qualified person who possesses a comparable training profile.

Conclusions: The requirement for a qualified person is very much oriented towards the comparable role in the drug product sector. Until now these requirements are only proposals. It will be exciting to see the real implementation in the final version.

To find out more please also see the proposal for "Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009".