The concept of Well-Established Technology (WET) plays an important role in the regulatory framework of the MDR in the EU. Understanding its applicability can significantly impact the clinical evaluation process and the overall regulatory pathway for medical devices. The term WET is referenced in Articles 52(5) and 61(8) of the MDR, but it lacks a precise definition within the regulation itself. MDCG 2020-6 provides more clarity, explaining that WET refers to devices that meet specific criteria: they must have relatively simple, common, and stable designs with little evolution; a well-known safety profile with no significant safety issues in the past; well-established clinical performance characteristics; and a long history on the market. Importantly, MDCG 2020-6 indicates that any device meeting all these criteria may be considered WET.
Designating a device as WET offers several advantages. Specifically, for legacy devices meeting the criteria of WET, a lower level of clinical evidence may be sufficient to confirm conformity with the relevant GSPRs, as detailed described in Annex III of MDCG 2020-6. For instance, cumulative evidence from clinical data of similar devices, complaints and vigilance data, and pre-clinical and bench testing may suffice, even in the absence of clinical investigations, if these are required based on the device’s risk class.
When developing new devices, the WET status can also streamline the clinical evaluation process. For example, the MDR lists specific implantable and Class III devices for which the requirement to perform clinical investigations under Article 61(4) does not apply, provided that the clinical evaluation is based on sufficient clinical data and complies with the relevant product-specific Common Specifications (CS), where such a CS is available. This list is clearly defined in Article 52(4) and Article 61(6b) and includes sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors. The MDR also explicitly states that the Commission is empowered to adopt delegated acts to amend this list of exempted devices by adding other types of implantable or Class III devices or by removing devices from the list. Thus, if interpreted literally, this exemption from clinical investigations applies only to the devices listed in the MDR and not to other devices that meet the definition of WET according to MDCG 2020-6.
This is the main pitfall in the interpretation of WET criteria, leading to confusion and frustration for manufacturers attempting to classify their devices as WET according to MDCG 2020-6 criteria, while notified bodies may limit this designation to devices explicitly listed in the MDR.
If you need a comprehensive analysis of your specific device for WET applicability and to define the appropriate regulatory pathway, contact us at [email protected].
