https://ec.europa.eu/newsroom/sante/newsletter-archives/77013
WET devices represent a simplified regulatory category under the EU MDR framework, designated for products with low iteration rates and high technological maturity.
Core criteria for WET classification:
The product features a universal, simple and long-stable design with minimal technological iteration;
Its safety and clinical performance profiles are well-defined, with no history of association with major safety incidents;
It is part of standard clinical treatment protocols, with almost no evolution in indications and technological level;
It has a long history of marketing and clinical application in the EU market, with highly controllable risks.
Amended provision: Article 52(4) of the MDR, replacing the original exemption list for per-unit technical document review of Class IIb implantable devices
Under the original MDR requirements, Class IIb implantable devices were subject to individual technical document assessment for each unit during the conformity assessment process. This new regulation significantly expands the exemption scope: products included in the list are exempt from per-unit review, which can markedly shorten the certification cycle of notified bodies.
Complete List of Exempted Products
Base categories:
Sutures, staples, dental filling materials, dental braces, dental crowns, screws, wedges, steel plates, steel wires, needles, clips, connectors
Newly added categories:
Cannulas, catheters, feeding tubes, surgical hemostatic cotton pads, suture cannulas, suture buttons, gastrostomy buttons, bone wax, bone filling materials, bone substitutes, medullary cavity positioners, diaphyseal occluders, radiopaque markers, fiber ligatures, transpalatal distractors, intramedullary nails, anchors, posterior spinal fixation devices, textile woven fabrics, dental implants, orthodontic appliances, dental barriers, suspension fixation devices and straps
Full title: Commission Delegated Regulation (EU) 2026/1451
Amended provision: Article 61(6)(b) of the MDR, replacing the original exemption list from mandatory clinical investigation for implantable and Class III devices
Products included in the list are not required to conduct new mandatory clinical investigations. Clinical evaluation can be completed based on existing global post-market data, clinical literature and industry consensus evidence, greatly reducing the time and financial costs of R&D and registration.
Important note: Exemption from mandatory clinical investigation does not equal exemption from clinical evaluation. Products on the list must still strictly comply with Article 61 of the MDR, complete clinical evaluation based on sufficient clinical data, and meet the relevant Common Specifications (CS) for the corresponding product, if applicable.
Base categories:Sutures, staples, dental filling materials, dental braces, dental crowns, screws, wedges, steel plates, steel wires, needles, clips, connectors
Newly added categories:
Official entry into force: The regulations shall enter into force on the 20th day following their publication in the Official Journal (29 June 2026), i.e., 19 July 2026.Scope of application: The regulations are binding in their entirety and directly applicable in all EU Member States, as well as the European Economic Area (EEA).
The entry into force of the two WET regulations marks a new phase of scientifically optimized, burden-reducing and efficiency-enhancing EU MDR regulation, and brings clear policy dividends for Chinese manufacturers of mature medical device categories entering the EU market. For further inquiries, please contact Wiselink.
As the largest and most well-regulated medical device market in Latin America, Brazil is a core target for Chinese medical device enterprises expanding into South America. To celebrate Wiselink’s 6th anniversary, we are offering a limited-time promotion: from 18 June to 18 July, a 20% discount on consultation service fees applies to medical devices of all risk classes for the Brazilian market. New and existing clients are welcome to contact us for consultation.
