8/19/2026 4:26:52 PM | less than a minute read

EU Expands Well-Established Technologies Under the MDR

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Christine Forcier

Get in touch

Christine Forcier

Color image of a set of surgical suturing instruments consisting of steel needle holder with suture and needle, forceps and scissor, resting on white surface

The European Commission’s expansion of the Well-Established Technologies (WET) list under the EU Medical Devices Regulation (MDR) could reduce regulatory burden for manufacturers of certain established implantable and higher-risk devices. Newly included technologies, such as sutures, staples, dental products, screws, catheters and feeding tubes, may qualify for exemptions from clinical investigations or, for certain Class IIb implantable devices, technical documentation assessment. This could help manufacturers reduce duplicative testing and documentation, streamline conformity assessment activities and potentially improve time to market.

However, the exemptions do not remove manufacturers’ broader MDR responsibilities. Manufacturers of qualifying implantable and Class III devices must still plan, conduct and document a clinical evaluation in accordance with MDR Article 61, meaning robust clinical evidence and compliant documentation remain essential. Manufacturers should review their portfolios to determine which products may now qualify, evaluate how the changes affect their clinical and regulatory strategies, and coordinate with their notified body to understand how the exemptions will be applied during conformity assessment.

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The European Commission has published two delegated acts that expand the list of well-established technologies (WET) under the Medical Devices Regulation (MDR) that are exempt from conducting clinical investigations and technical assessments.

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