Insights

On 20 March 2026, the European Commission adopted two Delegated Regulations amending Regulation (EU) 2017/745 (MDR) to expand simplified regulatory approaches for certain well-established technologies (WET).

The first Delegated Regulation, C(2026) 1798 final, expands the list of implantable and Class III devices exempted from the obligation to perform clinical investigations under Article 61(6)(b). The exemption applies where the clinical evaluation is based on sufficient clinical data and complies with relevant product-specific Common Specifications, where available. Manufacturers remain required to plan, conduct and document a clinical evaluation in accordance with Article 61 MDR.

The second Delegated Regulation, C(2026) 1809 final, expands the list of Class IIb implantable devices exempted from technical documentation assessment for every device under Article 52(4). The revised list includes additional technologies such as cannulas, catheters, bone substitutes, dental implants, orthodontic devices and posterior spinal fixation systems.

Both measures reflect experience gained with MDR implementation and concern technologies characterised by stable designs, well-known safety and clinical performance, and a long history on the EU market.

Both Delegated Regulations entered into force on 19 July 2026, making the updated exemptions applicable across EU Member States.

RPN will provide any further update and is available to provide full support for Medical Devices Regulatory Affairs activities.