Regulatory PRRC requirements
The requisite expertise shall be demonstrated by either of the following qualifications: (a) 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.
(b) Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices. Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.
Source: MDR and IVDR
statements according to a set of conditions required for the technical documentation, which can be found in Annex II, 1.1 of the IVDR 2017/746 document. Annex VIII contains the rules to be followed to determine the classification of the device, and is intended to be read and applied in sequence with Annex II. Therefore, referring as necessary to the documents (a), (c) and (d) listed on page 15, manufacturers must start by reviewing the implementing rules in chapter one. For example, is the device intended to be used in combination with another device? This is a particularly relevant question for software. After this, manufacturers must
read through the seven classification rules in chapter two and work through them step by step in order to arrive at a classification that best describes the device under consideration. It is important to document the decision on the classification and the supporting justification, as this is another required item in Annex II, 1.1, listed as follows: (e) the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII. Finally, it is also important to determine if the product is considered as a companion diagnostic (CDx), which is a specific type of IVD. CDx was not defined under the IVDD. But the IVDR, as well as ISO 20916, close this gap by defining CDx and identifying requirements for clinical performance studies. The EU IVDR defines a CDx as a device that is essential for the safe and effective use of a corresponding medicinal product to identify – before and/or during treatment – patients who are most likely to benefit from the corresponding medicinal product, or who are likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product.
Responsible persons
As with MDR and IVDR, the regulations oblige European companies to have a regulatory expert –
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Medical Device Developments /
www.nsmedicaldevices.com
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