Established medical devices (so-called legacy devices) have by no means become obsolete simply because they were previously only provided under the guidelines. What needs to be considered so that the products are not (have to be) withdrawn from circulation after the changeover to the MDR?
The new guidance, MDCG 2020-6 “Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC,” outlines recommended actions to help identify clinical data to demonstrate compliance with the MDR’s essential safety and performance requirements, which are needed as part of the technical documentation for medical devices already on the market. The term “legacy devices,” which is not defined in the MDR but is defined in this MDCG 2020-6, includes all medical devices that have achieved CE certification under MDD 93/42/EEC or AIMDD 90/385/EEC. In conjunction, MDCG 2020-6 provides a characteristic definition of medical devices with a “well-established technology”:
It is a simple product design that has remained largely the same, subject only to cautious evolutionary steps.
The generic product group to which the medical device in question belongs is well-established in a positive sense with regard to safety aspects; concerns regarding safety have not arisen in the past.
The clinical performance of the medical device is demonstrably known.
The associated generic product group represents standard medical care products without major expected adaptations with regard to indication, intended use or state of the art.
The medical devices concerned have been on the market for several years.
Only if all these aspects are fulfilled can one speak of a “well-established technology”.
The definition of “legacy devices” in particular, which MDCG 2020-6 provides to help classify clinical data, can have a significant impact on whether a manufacturer of class 3 devices or implantable devices can be required to conduct clinical investigations under Article 61, paragraph 4 of the MDR. Indeed, the MDR provides in Article 61, paragraph 6a, that manufacturers of medical devices of the above classification are exempt from the obligation to conduct clinical investigations to demonstrate conformity with the essential safety and performance requirements if the medical devices concerned “have been lawfully placed on the market or put into service in accordance with Directive 90/385/EEC or Directive 93/42/EEC and their clinical evaluation is
is based on sufficient clinical data and
is consistent with the relevant device-specific specifications for the clinical evaluation of this type of device, where these GS are available.”
The sticking point in the final assessment of these exemptions is the interpretation of the term “sufficient clinical data,” which is not further specified or defined in the MDR. Overall, according to the MDCG 2020-6 interpretation, the only statement that can be made is that both the two aforementioned guidelines and the MDR require a quantity and quality of clinical data that can demonstrate safety, performance, and a positive risk-benefit balance, and the conclusions derived must be scientifically valid.
In contrast, a universal definition of “clinical data” is found in the MDR, Article 2, paragraph 48:
Clinical data refers to “information on safety or performance obtained in the context of the use of a device and derived from the following sources:
clinical trial(s) of the device in question,
clinical trial(s) or other study(s) of a device reproduced in the scientific literature that can be shown to be similar to the device in question.
reports published in peer-reviewed scientific literature of other clinical experience with either the device in question or a device that can be shown to be similar to the device in question,
clinically relevant data from post-market surveillance, particularly post-market clinical follow-up.”
In this context, MDCG 2020-6 points out that although “legacy devices” are to be considered within the scope of the legal situation applicable at that time with regard to the original marketing authorization and the consequent demonstrated conformity with the GSPRs, as of the MDR validity date, the requirements of the MDR then apply, in particular for the PMCF and PMS area. Manufacturers of legacy devices should take this into account when considering their products clinically.
Although the MDR does not explicitly define “sufficient clinical data,” MDCG 2020-6 indicates that it is ultimately understood to mean the result of a qualified evaluation that allows the conclusion that the medical devices under consideration are safe and fulfill the intended medical benefit. Furthermore, it is emphasized that this evaluation, like the conduct of the clinical evaluation itself, is an ongoing process.
To provide clear guidance for the various phases of clinical evaluation for medical devices already on the market under the MDR requirement (Annex XIV, Part A of the MDR), MDCG 2020-6 addresses each of these phases:
Phase 0: Clinical evaluation plan and its update.
MDCG 2020-6 notes that in the case of legacy devices, considerations such as “first-in-man studies, feasibility studies, and pilot studies” do not apply, but the other points mentioned, such as specification of intended use, indications, contraindications, or user target groups, do. Equally important is post-marketing clinical surveillance, which is fundamentally of high importance under the MDR, both its detailed planning and implementation.
Phase 1: Identification of relevant clinical data
Ultimately, it is important to identify all available clinical data, both for the product itself and for the potential equivalent product. The definition of clinical data is still derived from Article 2, paragraph 48 of the MDR; here, the approach for legacy devices is no different from other cases. Especially in the post-marketing surveillance field, PMS data from the own vigilance system (complaints, incidents), results from conducted PMCF studies or also registry data can be used as data sources for “legacy devices”. In the case of established technologies on which the medical device concerned is based (“well-established technology”), data from similar products can also be used.
Phase 2: Assessment of relevant clinical data
Here, there is no difference to the general procedure for the assessment of clinical data: Determine the methodological quality of the data collected to classify the evidence in the overall context of the clinical evaluation using verified and validated assessment tools.
Phase 2a: Generation of new clinical data.
MDCG 2020-6 indicates that post-market clinical data should normally be available for products established on the market according to MEDDEV 2.12/2; nevertheless, it may be the case that data are available but do not meet the requirements of the MDR and also that the collection of clinical data via equivalence comparison is no longer possible (see also MDCG 2020-5). Then the generation of new clinical data becomes necessary for obtaining CE marking under the MDR.
Phase 3: Analysis of clinical data
Determine whether the clinical data collected and assessed in the previous phases of clinical evaluation are sufficient to meet compliance with the essential safety and performance requirements. The basis for this determination is the application of quantitative and qualitative analytical methods or the identification of potential gaps in reasoning or missing data.
The nature of clinical benefit depends largely on the product itself being evaluated and its intended purpose. While direct clinical benefit should be explicitly demonstrated using clinical data, other sources are required when demonstrating indirect clinical benefit, such as data from preclinical or bench tests.
When analyzing the risk, the combination of probability of occurrence and severity of the hazard plays the decisive role; this consideration takes place in the manufacturer’s central risk management system, which must generally be maintained and continuously updated. To this end, the MDR stipulates in Annex 1 that the manufacturer must reduce possible risks as far as possible; this includes the assessment and estimation of risks that may arise from a foreseeable misuse of the medical device.
With regard to the aspects of risk-benefit assessment, state of the art and alternative treatment methods, the following “guidance” results in MDCG 2020-6: For the stringent mapping of alternative treatment methods, which are available for almost all “legacy devices” to a greater or lesser extent, it is of great importance to restrict oneself primarily to those that correspond to the current standard. It does not make sense to rely on alternatives that are no longer practiced. In this context, the state of the art and its presentation is of great importance, as it can demonstrably underpin the classification of alternative treatment methods. However, even with this approach, it should be kept in mind that it is part of the scientific discourse to discuss different opinions and views. These should, as far as they exist, also be presented and commented on. Guidelines of the respective professional societies can always provide assistance in identifying the “true” state of the art, which, depending on the level of evidence, provide a more or less valid basis.
Based on the requirements of the MDR, it is recommended that manufacturers conduct a gap analysis in relation to the clinical data material and collect clinical data in specific areas where there are gaps. Conducting a clinical study is an option, but this can be very expensive and time-consuming; a systematic review of existing literature, for example, can be an alternative here. If it is not possible to close all the gaps, the inevitable consequence is to critically examine the claims and intended use, but also directly the indication; all aspects that cannot be substantiated with relevant data must be removed, with all the resulting consequences on the regulatory and, above all, commercial side. The lack of valid clinical data will come into play especially for many “legacy devices”. However, MDCG 2020-6 gives the indication that for low-risk, low-evolution devices, it may ultimately be possible to consider continuing to demonstrate compliance with the GSPRs even with limited clinical evidence – but this will then need to be reviewed on a case-by-case basis. This also applies to the requirement for PMCF data: Similarly, for “well-established technologies” with no or very low risk, there may be a requirement to collect clinical data, but again MDCG 2020-6 indicates that the evidence of clinical data is certain to be lower. It is also possible that the results of a well-founded and rigidly executed PMS system of the manufacturer are sufficient, from which a good clinical picture of the corresponding medical device for safety and performance can be derived, based on all recorded complaints and safety reports. For innovative and new technologies, but also for high-risk products, this approach will probably not work, because even if clinical data have been diligently collected in the past during the market phase, they do not necessarily meet the requirements of the MDR; here, too, it must then be examined on a case-by-case basis.
Finally, MDCG 2020-6 provides helpful guidance on the topics in its appendices:
The linking of MEDDEV 2.7/1 Rev. 4 with this guidance document with regard to further information on specific implementability.
A possible outline of a clinical evaluation plan covering all relevant requirements of the MDR in connection with legacy devices
An overview of the qualitative classification of clinical data in the context of demonstrating compliance with the GSPRs for legacy devices.
In the practical implementation of the MDR requirements and related to the recommendations of this MDCG guidance document, these appendices are an urgent recommendation for manufacturers of “legacy devices”. seleon GmbH is happy to support you in the evaluation of your established medical devices and their clinical data. So that the tried and tested also has a place in the future.
Please note that all data and listings do not claim to be complete, are without guarantee and serve purely as information.