MDR certification process explained
The certification process for medical devices under the Medical Device Regulation (EU) 2017/745 (MDR) is based on the device's risk class and the associated obligations for conformity assessment, with different routes and involvements required depending on the class.
Class I (low risk)
- Self-certification: The manufacturer drafts an EU Declaration of Conformity and affixes the CE marking to the product.
- No involvement of a Notified Body is required for non-sterile devices without a measuring function or reusable surgical instruments.
- For subcategories Is, Im, or Ir, the relevant specific characteristic (sterility, measuring function, reusability) must be assessed by a Notified Body.
Class IIa, IIb, and III (medium to high risk)
-Conformity assessment by a Notified Body is mandatory.
-The manufacturer selects the appropriate route based on the device class and intended purpose. Options include:
- Annex IX – Full Quality Management System (including technical documentation review and, for Class III, design dossier assessment)
- Annex X – EU Type-Examination
- Annex XI – Product verification (Part A: quality assurance / Part B: individual product verification)
-Technical documentation must comply with Annexes II and III and is subject to review by the Notified Body.
-Quality Management System (QMS) must be assessed by the Notified Body, typically aligned with ISO 13485.
-An EU Declaration of Conformity must be issued after successful assessment.
-The CE marking must be affixed to the device, including the Notified Body identification number.
Surveillance and Certificate Validity
-CE certificates under MDR are generally valid for up to five years.
-Annual surveillance audits are required.
-Recertification is mandatory before the certificate expires.
-Post-Market Surveillance (PMS) and vigilance obligations are essential to the ongoing compliance cycle.
A list of designated Notified Bodies is available in the European Commission’s NANDO database.