At the beginning of the year, we had anticipated how the European Commission was taking the first steps towards a simplification of the regulatory framework for medical devices and IVDs, with the objective of making the system more proportionate, efficient and competitive, without compromising safety levels.
A few months later, that direction finds its first concrete implementation.
With the delegated regulation adopted on 20 March 2026, the Commission intervenes directly on Article 61 of the MDR (Regulation (EU) 2017/745), expanding the list of implantable and class III devices exempted from the obligation to perform clinical investigations.
This is a targeted intervention, but with a strong operational impact.
What changes in practice
The core of the amendment concerns Article 61(6)(b) MDR.
The Commission has extended the list of devices considered to belong to “well-established technologies” (WET), namely technologies: with simple and stable design; with a well-known safety profile; with consolidated clinical performance; with a long history of use on the market.
For these categories, it will no longer be necessary to conduct new clinical investigations, provided that the clinical evaluation can be based on already available and adequate data.
Among the devices included we find, for example: sutures, clips, screws, plates and fixation systems; dental implants and orthodontic devices; catheters and vascular access devices; reusable surgical instruments; embolisation coils and other devices standard of clinical practice.
These are, therefore, devices widely used and already validated in clinical practice.
Attention: this is not deregulation
It is essential to clarify one point. The exemption concerns exclusively the obligation to perform clinical investigations but does not in any way eliminate the need demonstrate the clinical conformity of the device.
The manufacturer remains fully responsible for planning and conducting a solid clinical evaluation, based on sufficient and relevant clinical data. All of this, documenting in a robust manner the safety and performance of the device.
In other words, the obligation to generate new data through clinical studies is removed, but not the one to demonstrate, in a rigorous way, the clinical benefit of the device.
What is the rationale of the intervention
The regulation incorporates a principle that is now clear: not all technologies require the same level of evidence.
For devices with consolidated characteristics and known risk, the systematic obligation to conduct new clinical investigations risks translating into high costs and timelines incompatible with the market, without this being linked to a real additional benefit for patient safety.
The Commission’s intervention therefore goes in the direction of greater proportionality, already evoked in the proposals for revision of the system presented in recent months.
Impacts for operators
For manufacturers, this amendment opens concrete opportunities: reduction of time to market, with lower costs related to clinical studies and greater predictability of regulatory pathways.
At the same time, it requires a strengthening of clinical evidence strategies, through quality and robustness of the literature, clinical equivalence and post-market activities (PMCF).
A first step, not a point of arrival
The Commission is progressively introducing elements of greater flexibility and proportionality, maintaining unchanged the general structure of the regulation and the level of protection for patients.
Conclusion
What was anticipated at the beginning of the year is now starting to translate into concrete measures.
The challenge, now, will be to find the right balance between simplification and rigour: reducing burdens where not necessary, without weakening the quality of clinical evidence.
For companies in the sector, this is the moment to review their regulatory strategies, seizing the opportunities offered by this new approach, but without lowering the level of attention on data robustness.