EU: Medical devices – expansion of the list of well-established technologies 

 

The European Commission has issued a new delegated regulation under the Medical Devices Regulation (MDR). This initiative proposes to broaden the list of well-established technologies (WET) referenced in Regulation (EU) 2017/745, aiming to exempt these devices from certain legal requirements and thereby reduce administrative burden, while maintaining high standards of health and safety. 

Well-established technologies are generally simple devices with stable, widely used designs that have changed little over time. They are characterized by well-known safety profiles, established clinical performance, and a long history of use on the market. The criteria for identifying such technologies are set out in the Medical Device Coordination Group guidance (MDCG 2020-6). 

Under Article 61(6)(b) of Regulation (EU) 2017/745, certain technologies—by virtue of qualifying as WET—may benefit from a simplified regulatory pathway, including exemption from the requirement to conduct clinical investigations. 

The revised provision replaces point (b) with the following: 

Devices may qualify where their clinical evaluation is supported by sufficient clinical data and complies with relevant product-specific common specifications (CS), where available, and where they fall into specified categories. These include: 

• Sutures, staples, dental fillings, braces, crowns, and various fixation components such as screws, plates, wires, pins, clips, and connectors.  

• A broader range of surgical and medical devices, including cranial perforators, catheter passers, magnets for implantable pulse generators, needles, forceps, cannulas, balloon catheters, anticoagulant-coated catheters and blood bags, feeding tubes, bone-related products (e.g., fillers, substitutes, tacks), dental and orthodontic devices, spinal fixation systems, reusable surgical instruments, guidewires, pacing leads, embolisation devices, shunts, and internal defibrillation paddles.  

Overall, the amendment expands the scope of devices eligible for streamlined regulatory treatment, provided their safety and clinical performance are sufficiently demonstrated. 

To find out more about compliance for medical devices, do not hesitate to contact the Product Compliance Institute directly.