European Commission Expands MDR Exemptions for Well-Established Implantable and Class III Devices
- Date
- July 2, 2026
- Category
EU Regulations
- Description
The European Commission adopted Commission Delegated Regulations (EU) 2026/1451 and (EU) 2026/1359, amending Regulation (EU) 2017/745 (MDR).
Regulation (EU) 2026/1451 amends Article 61(6)(b) by expanding the list of implantable devices and Class III devices that may be exempt from the obligation to perform a clinical investigation, provided that the clinical evaluation is based on sufficient clinical data and complies with applicable Common Specifications, where available. Manufacturers remain required to plan, conduct, and document a clinical evaluation in accordance with Article 61 of the MDR.
Regulation (EU) 2026/1359 amends Article 52(4) by expanding the list of Class IIb implantable devices exempt from the requirement for a Notified Body to perform an assessment of the technical documentation for every individual device.
The Commission concluded that the additional device types constitute well-established technologies, characterized by common, simple and stable designs, well-known safety and clinical performance characteristics, little evolution in indications and the state of the art, and a long history of use on the Union market.
The newly added device categories include, among others,
- catheters,
- cannulas,
- feeding tubes,
- ventricular drains,
- dental implants,
- orthodontic devices,
- bone fillers,
- bone substitutes,
- anchors,
- nails,
- spinal posterior fixation devices,
- embolisation coils,
- guidewires, and
- reusable surgical instruments.
Manufacturers of the device types newly included in Articles 61(6)(b) and 52(4) may benefit from the exemptions introduced by these amendments, where the applicable conditions established in the MDR are fulfilled. The amendments are expected to reduce the regulatory burden and streamline conformity assessment activities for manufacturers of certain well-established implantable, Class IIb implantable, and Class III devices. The amendments published in March will come into force on July 19.