What is a “Well-Established Technology”?
Well-established technologies refer to medical devices that share several common characteristics:
- a simple and stable design;
- a technology that changes very little over time;
- well-known safety and clinical performance characteristics;
- a long track record of use in the European market.
According to the European Commission, these devices have been on the market long enough to justify relaxing certain regulatory requirements, without compromising the safety guarantees provided to patients.
Two delegated acts published
The published texts amend Regulation (EU) 2017/745 in two specific areas:
1. Expansion of the list of devices exempt from clinical investigation
Delegated Regulation (EU) 2026/1451 expands the list of implantable devices and Class III devices that may be exempt from the requirement to conduct a clinical investigation, provided that the conditions set forth in the MDR are met.
This trend is based on the observation that certain technologies already have a sufficient level of clinical evidence due to their history of use.
2. Streamlining the systematic review of technical documentation
Delegated Regulation (EU) 2026/1359 also expands the list of Class IIb implantable devices that may be exempt from the assessment of the technical documentation for each device by the notified body, provided that such devices are based on well-established technologies.
A list developed in collaboration with Member States and stakeholders
The list of technologies in question was not defined unilaterally by the Commission.
It is the result of the work of a dedicated working group of the Medical Device Coordination Group (MDCG) established in 2025, bringing together experts from the Member States. A public consultation (“Call for Evidence”) also allowed stakeholders to contribute to identifying technologies that could benefit from this simplified regime.
Effective Date
The two delegated regulations will enter into force 20 days after their publication in the Official Journal of the European Union, in accordance with the rules applicable to delegated acts.
What impact will this have on manufacturers?
For the manufacturers concerned, these delegated acts represent a significant development.
The main expected benefits are:
- a reduction in certain clinical demonstration requirements when permitted by the MDR;
- a reduction in the burden associated with assessments conducted by notified bodies for certain Class IIb implantable devices;
- greater proportionality between the actual level of risk posed by the device and the applicable regulatory requirements.
However, these texts do not call into question the fundamental obligations under the MDR. Manufacturers will still be required to demonstrate that their devices comply with the general safety and performance requirements, maintain effective post-market surveillance, and have comprehensive technical documentation.
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Read the full text here:https://ec.europa.eu/newsroom/sante/newsletter-archives/77013