Introduction
With the implementation of the Medical Device Regulation (MDR (EU) 2017/745), manufacturers must navigate complex regulatory pathways to demonstrate compliance with General Safety and Performance Requirements (GSPR). A key aspect of this process is the concept of Well-Established Technologies (WET), which is used under MDR Article 61 and defined in MDCG 2020-6.
While both uses of WET aim to streamline clinical evaluation and evidence requirements, they differ significantly in their scope, application, and benefits. Understanding these differences is crucial for manufacturers aiming to optimize their Clinical Evaluation Reports (CERs), reduce regulatory burden, and ensure compliance.
In this blog, we will:
✅ Compare WET under MDR Article 61 and WET under MDCG 2020-6
✅ Explain the benefits of WET status for manufacturers
✅ Provide key regulatory references and industry insights
What is WET Under MDR Article 61?
MDR Article 61.6(b) lists specific device groups that qualify as WET based on well-established clinical data. To be classified as a WET under this regulation, the device must:
1️⃣ Belong to a generic device group explicitly mentioned in Article 61.6(b): sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors.
Notified Bodies still expect to confirm that the new device does not introduce novel features or possess characteristics associated with emerging safety concerns.
Note: this list can be amended by Delegated Acts.
👉 Key takeaway: Only new devices that fall within the list of Article 61.6(b) and without significant novelty & safety concern can qualify as WET under MDR.
What is WET Under MDCG 2020-6?
The MDCG 2020-6 guidance expands the definition of WET beyond the Article 61.6(b) list for legacy devices to qualify if they meet additional criteria.
MDCG 2020-6 Criteria for WET Devices:
1️⃣ have relatively simple, common and stable designs with little evolution;
2️⃣ belong to a generic device group with well-known safety and has not been associated with safety issues in the past;
3️⃣ have well-known clinical performance characteristics and their generic device group are standard of care devices where there is little evolution in indications and the state of the art;
4️⃣a long market history ensuring reliability with extensive clinical data.
NBs expect a solid demonstration that all criteria are met.
👉 Key takeaway: Legacy devices of any classification can be WET under MDCG 2020-6, even if they are NOT listed in Article 61.6(b).
🚨 To avoid confusion, Notified Bodies (NBs) use two distinct terms:
🔹 “Standard of Care” → WET Legacy devices under MDCG 2020-6
🔹 “WET” → New devices under MDR Article 61.6(b)
Why Does WET Status Matter?
Achieving WET status offers significant benefits for manufacturers, particularly in clinical evaluation and regulatory compliance.
1️⃣ Benefits of “Standard of Care” Devices (MDCG 2020-6)
✅ Reduced the level of clinical evidence requirements in the Clinical Evaluation Report (CER)
✅ Pathway for exemption from clinical investigation per Article 61.6(a) for class III and implantable devices
✅ Ability to rely on data from similar devices to confirm compliance with GSPR in addition to other low level of clinical evidence such as complaints and vigilance data
🚨 Important Note: relying solely on complaints and vigilance data is NOT sufficient.
2️⃣ Benefits of WET Devices (MDCG 2023-7, Note 7)
✅ Opportunity to claim equivalence with another class III or implantable device without needing a contractual agreement needed with the manufacturer of the equivalent device
This provides manufacturers with more flexibility in demonstrating equivalence, simplifying the regulatory approval process to find sufficient clinical evidence to comply with GSPR.
Key Regulatory References & Industry Insights
📄 Regulatory Guidance:
🔹 MDCG 2020-6: Guidance on sufficient clinical evidence for legacy devices
🔹 MDCG 2023-7: Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence
📢 Industry Insight:
🔹 GMED Newsletter on WET & Clinical Evaluation Read here
📂 Download Regulatory Templates (CEP & CER) from LEXQARA’s Resource Center
Conclusion: Strategic Use of WET to Optimize Regulatory Compliance
For medical device manufacturers, understanding the distinction between WET under MDR Article 61 and WET under MDCG 2020-6 is critical to navigating the clinical evaluation process efficiently.
✅ Legacy devices (all classifications) can be WET under MDCG 2020-6, even if they are NOT listed in MDR Article 61.6(b)
✅ New WET devices under MDR must belong to the Article 61.6(b) list
✅ WET status offers significant regulatory benefits, such as reduced clinical data requirements and streamlined equivalence claims
🚀 Need expert guidance on Clinical Evaluation?
Visit LEXQARA’s Resource Center to download ready-to-use templates for CEP & CER!
📞 Contact us: +33 (0)6 87 45 88 07
📧 Email: alexandre.petiard@lexqara.com
Alexandre Pétiard, President, LEXQARA
