European Commission Expands MDR List of Devices Exempt from Clinical Investigations

On 20 March 2026, the European Commission adopted a Delegated Regulation amending Regulation (EU) 2017/745 (MDR) regarding the list of implantable and Class III devices exempted from the obligation to perform clinical investigations.

Background

Under Article 61(6)(b) MDR, certain devices may be exempt from clinical investigations if they are considered well-established technologies (WET).

According to the Commission, WET are devices that:

• Have common and stable designs

• Have well-known safety and clinical performance characteristics

• Have a long history on the market

Criteria for identifying WET have been previously defined in MDCG 2020-6 guidance.

What has changed?

Based on experience with the MDR, the Commission has expanded the list of implantable and Class III devices that may benefit from exemption from clinical investigations.

The amendment replaces Article 61(6)(b) and introduces an extended list of device types, including:

• Sutures, staples, dental fillings, dental braces, tooth crowns

• Screws, wedges, plates, wires, pins, clips, connectors

• Cranial perforators, catheter passers, cannulas, needles

• Catheters (including anticoagulant-coated), introducers, dilators

• Feeding tubes, ventricular drains, gastrostomy buttons

• Bone-related products (e.g. bone fillers, bone substitutes, bone wax)

• Dental implants, orthodontic devices, dental veneers

• Guidewires, pacing wires and leads

• Embolisation coils and particles

• Shunts and internal defibrillation paddles

• Reusable surgical instruments

Consultation process

The list was developed in 2025 following consultation with stakeholders, including:

• MDCG working groups

• Competent Authorities

• Other relevant stakeholders with observer status

Important requirement remains

Although these devices are exempt from the obligation to perform clinical investigations, manufacturers must still:

• Plan, conduct and document a clinical evaluation in accordance with Article 61 MDR

• Ensure that the clinical evaluation is based on sufficient clinical data

• Comply with relevant Common Specifications (CS) where available

Entry into force

The Regulation will enter into force 20 days after its publication in the Official Journal of the European Union.

Read the full document below.