ISO 13485 / MDR

1. Clinical evaluation - are we qualified to complete this ourselves? I have documented professional experience of >14 years but not a medical degree

It is not necessary to have a medical degree to make a clinical evaluation report. Clinical evaluation should be understood as a key document that has all the necessary information to understand the medical device and to prove its purpose. It is a comprehensive document, very detailed and extensive. Therefore, it is extremely important that it is written by a competent person who understands the product to who understands a medical product to its very core - both structurally and in terms of its medical purpose. Another important fact is that the person who will do the clinical evaluation must have experience in searching the scientific literature and be able to determine which literature is relevant and why. This is usually proven by a CV, the number of published papers, or some scientific title such as a master's degree or a doctorate.

2. MDR requires a suitably qualified person to act as the person responsible for regulatory affairs - is there any definition about what suitably qualified means?

Yes, in article 15 – Person for regulatory compliance, in point 1 are stated the competencies:

• a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized 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;

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

For further information, see:

• EU MDR Article 15 https://advisera.com/13485academy/mdr/person-responsible-for-regulatory-compliance/