Well-Established Technologies: What Does MDCG 2020-6 Require?

Many medical devices have been on the market for years or even decades. But does that automatically qualify them as "well-established technologies"? And what does this mean in concrete terms for the clinical evidence required by the MDR? Dr. rer. nat. Marion Fehlker of novineon CRO describes below what the MDR and the MDCG documents understand by well-established technologies, and what clinical requirements apply to products in this category.

Definition

The Medical Device Regulation 2017/745 (MDR) does not provide a definition of "well-established technologies." It merely refers to devices similar to those listed in Article 61, paragraph 6(b), namely: "sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, dental or bone plates, wires, pins, clips or connectors."

MDCG 2020-6 builds on this, emphasizing that well-established technologies are not limited exclusively to the products listed, but explicitly also include similar ones.

The following characteristics of well-established technology products are identified in MDCG 2020-6:

• Simple, common, and consistent design with little further development
• The generic product group is known to be safe and has not been associated with safety concerns
• Well-known performance characteristics Standard-of-care products with little further development
• Long-standing market presence

In the view of MDCG 2020-6, all products fulfilling these criteria may therefore be considered well-established technologies.

MDCG 2020-6 defines "legacy devices" as products that were already on the market under the Medical Devices Directives 93/42/EEC (MDD) or 90/385/EEC (AIMDD). A well-established technology product may therefore simultaneously qualify as a legacy device, but is not required to do so.

Clinical Evaluation Required

Clinical evaluations based on sufficient clinical data are necessary for all devices – including those listed in MDR Article 61, paragraph 6(b) – as MDCG 2020-6 makes clear.

However, this subgroup of products does not necessarily require clinical investigations, even where they are Class III devices or implants that have not yet received CE marking.

Clinical evaluations and PMCF measures are also required for well-established technology products

This applies, however, only to the aforementioned subgroup and not to all well-established technology products in general. The clinical evaluation for well-established technology products may be based on clinical data from similar devices. In particular, data on similar devices may also be used to substantiate that a product belongs to the well-established technology category – in accordance with the criteria listed above. Such data can be used, for example, to demonstrate the ubiquity of the design, the absence of novelty, and the well-known safety and performance profile of the generic product group.

Without Clinical Data Only in Exceptional Cases

If demonstrating conformity with the general safety and performance requirements on the basis of clinical data is considered inappropriate, non-clinical test methods – such as technical testing and preclinical evaluations – may be used in accordance with MDR Article 61(10). However, this approach must be substantiated by solid justification based on the specific characteristics of the device and its intended clinical performance.

For many well-established technology products, this approach is appropriate, even though neither the MDR nor MDCG 2020-6 directly addresses these products in this context.

MDCG 2020-13 notes that even when applying MDR Article 61(10), a clinical evaluation is still required. Furthermore, clinical data on the device and on similar devices should also be researched and evaluated in this case.

Lower Levels of Clinical Evidence May Suffice

According to MDCG 2020-6, in exceptional cases – particularly for standard-of-care products associated with low risk and corresponding to well-established technologies – a lower level of clinical evidence may be sufficient to confirm conformity with the relevant general safety and performance requirements. Clinical data from a well-conducted post-market surveillance program may be used in a supporting capacity.

In this context, the guidance identifies the following types of clinical data that may be sufficient for well-established technology products:

• Reliable and quantifiable clinical data on equivalent devices
• Evaluation of the state of the art, including clinical data; data on similar devices may be used in a supporting capacity
• Complaints and post-market surveillance data
• Data from proactive post-market surveillance

PMCF Often Required

For well-established standard products with no known safety concerns, post-market surveillance meeting the requirements of the MDR has frequently not been conducted in the past. At the same time, such products are typically not the subject of clinical research, meaning that little or no clinical data is available in the literature.

It may therefore be necessary, according to MDCG 2020-6, for well-established technology products – even those that have been on the market for decades – to conduct Post-Market Clinical Follow-Up (PMCF) activities in order to collect the clinical data required for certification.

Conclusion

• Simple standard-of-care medical devices may belong to the category of "well-established technologies." This must be assessed against the criteria set out in MDCG 2020-6 and substantiated in the clinical evaluation.
• Data from similar devices may be used to justify classification against the criteria list.
• A clinical evaluation based on sufficient clinical data is required for well-established technology products as well. In this context, data of lower evidence levels may suffice.
• In justified exceptional cases, the clinical evaluation may be conducted on the basis of non-clinical data.
• Where no clinical data is available, PMCF activities may be required even for established well-established technology products in order to collect clinical data.