Oct 23, 2019

The European Medical Device Coordinating Group (MDCG) has updated a Question and Answer resource document covering compliance requirements related to Notified Bodies and joint assessments under the upcoming Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR).

Initially published earlier in 2019, the Q&A document now covers several new issues Notified Bodies are recommended to address as they evaluate and certify medical device and IVD manufacturers under the new Regulations:

Supplier and subcontractor audits

Regarding audits of any suppliers or subcontractors utilized by a manufacturer, Notified Bodies should establish criteria for auditing such entities based on recommended approaches found in Annex VII of the MDR as well as MDCG’s own guidelines. “The notified body should have criteria for auditing these actors on the basis of their criticality,” states MDCG in the document.

Re-registration requirements

CE Mark certification renewals and validity extensions may occur under the MDR and IVDR provided that Notified Bodies undertake appropriate conformity assessment procedures, according to the MDCG document.

Notified Bodies must use the same methods and processes for determining recertification of a device as used for the product’s initial certification. Furthermore, Notified Bodies are responsible for assessing all pertinent MDR or IVDR requirements pertaining to audits at least once before expiration of a certificate.

For ISO 13485 quality system certificates, Notified Bodies should assess surveillance audits as well as audit results of any subcontractors and suppliers before renewing these certificates.

New definitions

The updated Q&A document also provides new and clarified definitions of several relevant terms, such as:

  • “Employed” in the context of MDR means that personnel carrying out key functions within a Notified Body should be employed by that entity, entailing direct employment contracts, supervision, reporting obligations and renumeration.
  • “Two years’ professional experience” means that a product reviewer within a Notified Body must have two years of professional experience in design, manufacture, testing or use of a particular device or technology undergoing assessment for certification. In cases where professional experience pertains to activities within a Conformity Assessment Body, such experience must have been gained over at least two years, as well.

MDCG’s clarifications and additions to the Notified Body Q&A resource follows a gradual uptick in the designation of Notified Bodies under the new Regulations; TÜV Rheinland and IMQ most recently obtained designation for MDR, while DEKRA has become the first Notified Body to receive IVDR designation.

Related European medical device and IVD regulatory resources from Emergo by UL: