Nuevas actualizaciones del MDR para tecnologías bien establecidas
On 29 June 2026, two new Delegated Regulations amending the Medical Device Regulation (EU) 2017/745 (MDR) were published in the Official Journal of the EU: Commission Delegated Regulation (EU) 2026/1359, expanding the list of Class IIb implantable devices exempt from notified body technical documentation assessment for every device, and Commission Delegated Regulation (EU) 2026/1451, expanding the list of implantable and Class III devices exempt from the obligation to perform clinical investigations.
Both Regulations are based on the recognition that certain established device technologies have demonstrated consistent safety and performance over many years of clinical use and therefore may warrant a more proportionate regulatory approach.
Key Updates
Expanded exemption from technical documentation assessment
Delegated Regulation (EU) 2026/1359 expands the list of Class IIb implantable devices exempt from the requirement that notified bodies assess the technical documentation of every individual device during conformity assessment.
Newly added examples include:
- Cannulas and catheters
- Feeding tubes and gastrostomy buttons
- Bone wax, bone fillers and bone substitutes
- Dental implants and orthodontic devices
- Anchors, nails and spinal posterior fixation devices
- Textile braids, suspensory fixations and cinches
Expanded exemption from clinical investigations
Delegated Regulation (EU) 2026/1451 expands the list of implantable and Class III devices that may be exempt from performing clinical investigations, provided that:
- sufficient clinical data are available,
- the clinical evaluation complies with applicable Common Specifications (where available), and
- MDR clinical evaluation requirements remain fulfilled.
The expanded list includes many well-established technologies, such as:
- Cannulas and specialised catheters
- Feeding tubes and gastrostomy buttons
- Bone fillers and bone substitutes
- Dental implants, dental veneers and orthodontic devices
- Reusable surgical instruments
- Guidewires, pacing wires and leads
- Endovascular embolisation coils and embolisation particles
- Shunts and internal defibrillation paddles
Importantly, manufacturers remain required to perform and document a clinical evaluation in accordance with MDR Article 61.
A More Proportionate, Risk-Based Approach
These amendments reflect the Commission's intention to apply a more proportionate and risk-based regulatory approach to well-established technologies.
For qualifying devices, manufacturers may benefit from:
- Reduced notified body review requirements for certain Class IIb implantable devices
- Reduced need to generate new clinical investigation data where sufficient clinical evidence already exists
- More efficient conformity assessment activities while maintaining high levels of safety and performance
The updates acknowledge that some mature technologies no longer require the same level of regulatory scrutiny as novel or rapidly evolving devices.
What Does This Mean for You?
Manufacturers should assess whether any products in their portfolio qualify as well-established technologies under the expanded exemption lists.
For affected devices, the changes may influence:
- Clinical evidence strategies
- Clinical investigation planning
- Technical documentation requirements
- Notified body interactions
- Certification timelines and resource allocation
However, manufacturers should note that the exemptions do not remove the obligation to maintain robust clinical evaluations and supporting evidence demonstrating compliance with MDR requirements.