CertExe’s path to becoming an MDR notified body

CertExe was founded with a clear goal: to become an MDR notified body for medical devices and to offer accredited ISO 13485 certification. The first formal step is complete; we have submitted our accreditation application to Accredia and our designation application to the Italian Ministry of Health. In this article, we explain how the two processes work and where we stand.

ISO 13485 accreditation and designation as an MDR notified body

Accreditation with Accredia. Accredia is Italy’s national accreditation body. It assesses whether a body that certifies quality management systems is competent, independent and impartial. The process includes:

• a review of our documentation;
• an assessment at our offices;
• a number of witnessed assessments, in which Accredia’s assessors observe one of our audits at a manufacturer’s site.

Designation with the Ministry of Health. In Italy, the authority responsible for notified bodies for medical devices is the Ministry of Health. Once the application has been reviewed, a joint assessment takes place under Article 39 of Regulation (EU) 2017/745, with experts from the European Commission and other Member States. If the outcome is positive, the body is notified and receives an identification number, published in the European NANDO database.

Where we stand

Our applications have been submitted and we are now in the accreditation and designation phase, working through the various assessment stages with the authorities. We are not giving timelines, as these depend on the authorities and on the complexity of each stage. We will share every key milestone here, in our News section.

What we are building in the meantime

Our team comes from several notified bodies and has brought together its experience and methods to create something new, focused entirely on medical devices. Over these months we are strengthening:

• our quality management system;
• our assessment procedures;
• the qualification of our technical and clinical staff;
• the tools that allow us to work with manufacturers in a clear and predictable way.

These are the same requirements that Annex VII of the Regulation sets out for every MDR notified body.

We are also preparing our first courses and a number of free guides on the MDR and ISO 13485; they are general training, fully in line with our commitment to impartiality.

Follow our journey

To receive updates and new articles, subscribe to our newsletter or follow us on LinkedIn. If you are considering certification for your devices or your quality management system, tell us about your company on our Application page.