Numerous medical devices have been on the market for many years or even decades. But do they automatically count as «well-established technologies»? And what does this mean for the clinical evaluation and the clinical evidence required by the MDR? Dr. rer. nat. Marion Fehlker from novineon CRO describes what MDR and MDCGs mean by “well-established technologies” and what clinical requirements apply to this product group.
Medical Device Regulation 2017/745 (MDR) does not provide a definition for well-established technologies. The MDR only mentions devices similar to those listed in Article 61, paragraph 6(b), namely: „sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors“.
The MDCG 2020-6 document fills this gap and emphasizes that well-established technologies do not exclusively comprise the products mentioned above, but also similar devices.
As characteristics for products of well-established technologies, MDCG 2020-6 names:
- 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 issues
- well known performance characteristics
- standard of care products with little further development
- on the market for a long time
From the view of MDCG 2020-6, therefore, all products that meet these criteria can be considered well-established technologies.
MDCG 2020-6 also defines „legacy devices“ - i.e., existing products that have been on the market under the Medical Device Directives 93/42/EEC (MDD) or 90/385/EEC (AIMDD). A product of well-established technology can therefore also be a legacy device at the same time but does not need to.
Clinical evaluation necessary
MDCG 2020-6 clarifies that clinical evaluations based on sufficient clinical data are required for all devices, including devices identified in MDR, Article 61, paragraph 6(b).
However, this subset of devices does not necessarily require clinical investigations, even if the devices have not previously been CE-marked and are class III devices or implants. However, this only applies to the aforementioned subgroup and not to well-established technology devices in general.
Clinical evaluations and PMCF measures are required even for established products
The clinical evaluation for well-established technology devices may be based on clinical data for similar devices. In particular, data for similar devices may also be used to justify that a product belongs to the group of well-established technology - according to the criteria mentioned above. For example, these data can be used to demonstrate the ubiquity of the design, the lack of novelty, and the known safety and performance profile of the generic device group.
No clinical data only in exceptional cases
If demonstration of compliance with the general safety and performance requirements based on clinical data is deemed inappropriate, results of nonclinical test methods, e.g., technical tests and pre-clinical evaluations, may be used in accordance with MDR Article 61(10). However, this approach must be duly justified based on the specific characteristics of the device and the intended clinical use.
This approach is appropriate for many products of well-established technologies, even though neither MDR nor MDCG 2020-6 directly refer to these products.
MDCG 2020-13 states that even if MDR Article 61(10) is applicable, a clinical evaluation will still be required. Furthermore, clinical data for the device under evaluation or for similar products should still be gathered and evaluated.
Lower-level clinical evidence may be sufficient
According to MDCG 2020-6, in exceptional cases, especially for standard of care devices that are associated with low risk and are well-established technologies, a lower level of clinical evidence may be sufficient to confirm compliance with the relevant general safety and performance requirements. Supportively, clinical data from well-conducted market surveillance may be used.
Here, the guidance specifies the following types of clinical data that may be sufficient for products of well-established technologies:
- reliable and quantifiable clinical data for equivalent products
- evaluation of the state of the art, including clinical data; data for similar products may be used in a suppotive manner
- complaints and market surveillance data data from proactive market surveillance
PMCF often required
For well-established standard devices without known safety issues, manufacturers often did not conduct market surveillance that meets MDR requirements. At the same time, such products are usually not the subject of clinical research, so little or no clinical data are available in the literature.
Therefore, according to MDCG 2020-6, it may be necessary to initiate postmarket clinical follow-up measures to collect clinical data for certification, even for products of well-established technologies that have been on the market for decades.
- Simple standard of care medical devices may belong to the group of well-established technologies. The fulfillment of the criteria listed in MDCG 2020-6 should be assessed and stated in the clinical evaluation.
- Data from similar products may be used to justify the fulfillment of the criteria.
- A clinical evaluation based on sufficient clinical data is required even for products of well-established technologies. In this case, data of lower levels of evidence may be sufficient.
- In exceptional cases, the clinical evaluation may be based on nonclinical data.
- If there are no clinical data, PMCF measures may be required even for established products of well-established technologies.