Medical device manufacturers with well-established technologies (WETs) in their portfolios may have a lighter regulatory lift under the European Commission’s expanded list of WET device categories. In August 2026, the Commission issued two delegated regulations that expand the WET device categories eligible for exemptions from certain clinical investigation and notified body (NB) technical documentation assessment requirements.

Depending on the device category, manufacturers may benefit from an exemption from clinical investigation requirements, NB technical documentation assessment for every device, or both. As a result, the EC’s decision to expand the WET device categories has the potential to reduce the regulatory burden for certain manufacturers. It also aligns with the shift toward a more risk-based, proportionate approach under the MDR as outlined in the December 2025 proposed reforms.

For manufacturers, the expanded WET device categories provide greater clarity on which devices may qualify for regulatory relief. The challenge now is to determine where those exemptions apply across a product portfolio and how they could affect clinical evidence strategies, NB interactions, regulatory timelines, and certification costs.

The opportunity to rethink regulatory strategy

Many orthopedic, spinal, cardiovascular, and other device technologies are now formally recognized as WETs under one or both MDR delegated regulations. However, the lists of devices exempt from clinical investigations and individual NB technical documentation assessment are not identical.

Manufacturers must understand how these exemptions apply to their specific products and product portfolios. Table 1 provides a breakdown of the devices grouped by therapeutic area and identifies which exemptions apply to each device category.

Table 1. Expanded WET device categories and applicable MDR exemptions.

WETs exempt from clinical investigations

Article 61(6)(b) Amendment (EU 2026/1451) expanded the list of well-established implantable and Class III devices that may be exempt from the requirement to conduct a clinical investigation under the MDR. This amendment may present a significant opportunity to reduce regulatory burden for manufacturers of qualifying devices.

However, the exemption from clinical investigations should not be considered a regulatory "free pass." Manufacturers must still demonstrate the safety, performance, and positive clinical benefit-risk profile of their devices through a robust clinical evaluation supported by sufficient clinical evidence.

For legacy devices already marketed in the EU, existing post-market surveillance (PMS) data may provide an important source of clinical evidence. Similarly, manufacturers of devices that have been marketed outside the EU may be able to leverage a range of clinical evidence to support CE marking, provided the evidence meets MDR requirements and NB expectations.

Examples of relevant clinical evidence include:

• Existing clinical experience
• PMS data
• Patient registries
• Published literature

In all cases, the quality, relevance, and sufficiency of the available evidence remain critical considerations during conformity assessment.

The amendment may also create new opportunities for manufacturers that want to bring WET devices to the EU market for the first time. Costly, time-consuming prospective clinical investigations may not be necessary if the manufacturer can demonstrate sufficient clinical evidence through alternative sources.

For new devices without prior clinical use or device-specific PMS data, identifying and justifying appropriate sources of clinical evidence in the absence of a clinical investigation is challenging. In these circumstances, a carefully planned regulatory strategy and clinical evaluation approach become essential to demonstrate compliance with MDR requirements.

The key question for manufacturers is no longer:

• "Do we need a clinical investigation?"

Instead, manufacturers must ask:

• What clinical evidence is already available?
• Is the available PMS evidence sufficient to satisfy MDR requirements?
• What evidence gaps remain?
• Can the WET exemptions presented in Table 1 be leveraged?
• What is the most appropriate clinical evidence strategy for the device?
• What is the most cost-effective route to CE marking?

WETs that qualify for NB technical documentation sampling

Article 52(4) Amendment (EU 2026/1359) expanded the list of well-established Class IIb implantable devices that are exempt from NB assessment of the technical documentation for every device during conformity assessment. The newly included device categories were recognised as WETs based on their long history of clinical use, well-characterised safety and performance profiles, and stable technological design. As a result, manufacturers of eligible Class IIb implantable devices listed in Table 1 may benefit from reduced individual technical documentation review through the MDR technical documentation sampling process.

For manufacturers, this exemption has the potential to improve the efficiency and cost-effectiveness of conformity assessment activities by reducing the number of individual technical documentation reviews that may be required across a device portfolio. However, the exemption does not reduce the underlying MDR requirements relating to safety, performance, quality management systems, clinical evaluation, post-market surveillance, or technical documentation. Manufacturers remain responsible for demonstrating full compliance with all applicable MDR requirements.

To fully benefit from the Article 52(4) exemption, manufacturers should carefully consider their regulatory strategy, particularly with respect to device family definitions, product grouping, and technical documentation structures. Appropriate portfolio organisation can have a significant impact on NB sampling approaches, review effort, certification timelines, and ongoing surveillance costs. Conversely, poorly defined device groupings or technical documentation structures may limit the potential benefits offered by the exemption.

A well-planned device grouping and technical documentation strategy can help manufacturers maximize the potential benefits of NB sampling while maintaining compliance with MDR requirements.

How IQVIA MedTech Supports WET Manufacturers

IQVIA MedTech helps manufacturers across therapeutic areas determine whether specific devices, device families, and technology platforms can benefit from one or both WET exemptions. Drawing on extensive MDR and NB experience, IQVIA enables manufacturers to translate these regulatory exemptions into practical reductions in regulatory burden, review costs, and time to CE marking.

Whether supporting a legacy MDR transition, the certification of a new device, or market entry for products already commercialized outside the EU, IQVIA can help manufacturers:

• Assess whether products qualify for the newly expanded WET exemptions.
• Develop compliant device grouping, device family, and technical documentation strategies to maximize the benefits of the Article 52(4) exemption.
• Develop clinical evaluation strategies that leverage existing evidence, assess its suitability against MDR and NB expectations, and identify and address evidence gaps where needed.
• Identify efficient regulatory pathways for first-time EU market access, MDR transition, and portfolio expansion.

Our regulatory, clinical, and NB expertise can help manufacturers translate the regulatory flexibility offered by these exemptions into a practical and efficient pathway to MDR certification and CE marking.

Conclusion

The recent MDR amendments create a significant opportunity for manufacturers of WET devices to reassess their EU regulatory strategies and potentially reduce the cost and time required to achieve MDR certification.

With the release of the expanded WET device category list, the regulatory challenge shifts from generating new clinical evidence to strategically leveraging existing evidence and optimizing the overall conformity assessment approach. By doing so, manufacturers may reduce regulatory burden, accelerate market access, and optimize certification costs.