Route to CE-Certification under MDR 2017/745

 
The classification of a medical device under the Medical Device Regulation (EU) 2017/745 (MDR) determines the required conformity assessment procedure and the involvement of a Notified Body. Below is an overview of the most common certification routes:
 
Class I (low risk)
- Class I (non-sterile, no measuring function, not reusable surgical instruments):
  • Self-certification by the manufacturer.
  • Drafting of an EU Declaration of Conformity.
  • Affixing of the CE marking to the product.
- Class I (sterile – Is, with measuring function – Im, reusable surgical instruments – Ir):
  • Assessment of specific aspects (sterility, measuring function, reusability) by a Notified Body.
  • Self-certification for other aspects.
  • Drafting of an EU Declaration of Conformity.
  • CE marking must include the identification number of the Notified Body.
Class IIa (medium risk)
- Conformity assessment via one of the following routes:
  • Annex IX: Full Quality Management System (QMS) including assessment of technical documentation.
  • Annex XI Part A: Product quality assurance and review of technical documentation.
  • Annex XI Part B: Product verification.
- Involvement of a Notified Body is mandatory.
- EU Declaration of Conformity must be drawn up.
- CE marking must include the Notified Body’s identification number.
 
Class IIb (high risk)
- Conformity assessment via one of the following routes:
  • * Annex IX: Full Quality Management System (QMS) with technical documentation review.
  • * Annex XI Part A: Product quality assurance.
  • * Annex XI Part B: Product verification.
- Notified Body involvement is required.
- Drafting of an EU Declaration of Conformity.
- CE marking with Notified Body identification number is mandatory.
 
Class III (very high risk)
- Conformity assessment options:
  • * Annex IX: Full QMS including technical documentation and design dossier review.
  • * Annex X: Type examination.
  • * Annex XI Part B: Product verification.
- Notified Body involvement is mandatory.
- EU Declaration of Conformity must be drawn up.
- CE marking must include the Notified Body’s identification number.
 
Key Considerations
  • Quality Management System (QMS): A QMS aligned with ISO 13485 is typically required for all classes.
  • Technical Documentation: Must meet the requirements of Annexes II and III of the MDR.
  • Clinical Evaluation: Required for all device classes, with increasing complexity for higher risk classes.
  • Post-Market Surveillance (PMS): A PMS plan must be developed and implemented in accordance with Articles 83–86 of the MDR.