Clinical trial exemption for medical implants: what changes for manufacturers in 2026

Key data

If you manufacture medical implants or class III devices and operate in the European Union, this regulation directly affects your product development and certification roadmap. The Delegated Regulation (EU) 2026/1451, published on 29 June 2026, amends Regulation (EU) 2017/745 by updating the annex of products that are exempt from the obligation to conduct prior clinical investigations before commercialization.

The key lies in the exemption criterion: the regulation allows it to be invoked when there are sufficient clinical data from equivalent products already on the market. This makes reviewing the updated list a strategic decision with direct impact on costs and timelines.

What does this regulation establish?

Regulation (EU) 2017/745 on medical devices established that implantable devices and class III devices—those with the highest risk—must undergo clinical investigations before commercialization. However, it provided for an exception: those products for which robust clinical data from equivalent products already on the market exist may be exempt from that requirement.

The new Delegated Regulation (EU) 2026/1451 updates the annex that lists those exempt products. The specific changes it introduces are:

• Update of the list of implantable products and class III devices that may be eligible for the exemption from prior clinical investigation.
• Application of the exemption conditioned on the existence of sufficient clinical data from equivalent products already on the market.
• New criteria to be applied by notified bodies and competent authorities in conformity assessment procedures.

Economic and operational impact

Prior clinical investigation before commercialization of a class III medical device is one of the most costly and time-consuming processes in the sector. It involves protocol design, patient recruitment, follow-up, statistical analysis, and submission to authorities. Timelines can extend several years and costs can reach several million euros per product.

Being on the exemption list has very high economic and strategic value:

• Timeline reduction: avoiding clinical investigation can shorten the time to commercialization by years.
• Cost savings: manufacturers can replace clinical investigation with evaluation of existing clinical data from equivalent products, a significantly less costly process.
• Competitive advantage: reaching the market earlier with a certified product provides a direct advantage over competitors who must conduct trials.
• Risk from omission: a manufacturer who does not review the updated list and assumes their product is still (or is not) exempt may incur non-compliance during conformity assessment, with consequent delay or rejection of certification by the notified body.

Who does it affect?

• Manufacturers of implantable medical devices that commercialize or plan to commercialize in the EU.
• Manufacturers of class III devices (the highest risk category under Regulation 2017/745).
• Notified bodies responsible for conformity assessment of these products, which must apply the new criteria.
• National competent authorities that supervise regulatory compliance in medical devices.
• Regulatory and R&D departments of medtech companies that manage the pipeline of new products.
• Regulatory advisors and specialized consultancies in medical device certification in the EU.

Practical example

Imagine a manufacturer of orthopedic implants that has a new hip prosthesis model—a class III device—in development and was planning a three-year clinical trial to comply with Regulation 2017/745.

With the publication of Delegated Regulation (EU) 2026/1451, the regulatory department reviews the updated annex list and finds that their type of implant has been included among exempt products, as sufficient clinical data exists from equivalent devices already on the European market.

Result: the company can replace the clinical trial with an evaluation of clinical data from equivalents, potentially saving years of development and significant costs, and advancing its market entry. Without that review, it would have initiated an unnecessary process with a direct impact on its budget and competitive position.

What should companies do now?

1. Review the updated annex of Delegated Regulation (EU) 2026/1451 to identify whether products in development or in portfolio are included in the new exemption list.
2. Assess the impact on the product pipeline: for each implantable or class III device, determine whether the exemption applies and what clinical data from equivalents are available.
3. Update the regulatory plan for each affected product: if the exemption applies, replace clinical trial planning with a process of evaluating existing clinical data.
4. Coordinate with the notified body to confirm that the new criteria of the delegated regulation are correctly applied in the ongoing or planned conformity assessment procedure.
5. Document the exemption justification rigorously: although no clinical investigation is conducted, the company must demonstrate the sufficiency of clinical data from equivalents to the notified body.
6. Review contracts and agreements with CROs (contract research organizations) if preparations for clinical trials that may no longer be necessary have already been initiated.

Official source

Consult complete regulation in official source

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=CELEX:32026R1451