Opening Summary
The European Commission has adopted a new delegated regulation amending Article 61 of Regulation (EU) 2017/745 (MDR), significantly expanding the range of medical devices eligible for exemption from clinical investigations.
The amendment recognizes a broader category of well-established technologies and introduces meaningful regulatory simplifications for manufacturers, particularly those marketing Class IIb implantable devices.
Key Changes
Expanded List of Exempted Devices
The revised exemption framework now covers numerous established devices across:
- Dentistry
- General Surgery
- Gastroenterology
- Gynecology
- Neurosurgery
- Cardiovascular and Interventional Medicine
- Blood Transfusion
- Reusable Surgical Instruments
Important Clarification: Clinical Evaluation Remains Mandatory
Although eligible devices may be exempt from conducting new clinical investigations, manufacturers must still perform clinical evaluations in accordance with MDR Article 61 and Annex XIV.
Clinical evidence may be generated through:
- Scientific literature
- Post-market surveillance data
- Equivalent device data
- Clinical experience
Significant Benefit for Class IIb Implantable Devices
The amendment introduces a simplified conformity assessment pathway for certain exempted Class IIb implantable devices.
Rather than requiring a full technical documentation review for each device, Notified Bodies may rely on:
- Technical documentation sampling
- Quality Management System audits
This change has the potential to reduce certification timelines and regulatory costs.
Recommended Actions for Manufacturers
Manufacturers should:
- Review their product portfolios against the updated exemption list
- Reassess clinical evidence strategies
- Engage early with their Notified Bodies
- Update clinical evaluation documentation accordingly
Effective Date
The amendment will enter into force 20 days after publication in the Official Journal of the European Union and will be directly applicable in all EU Member States.