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.