Legacy devices are medical devices that were previously CE-marked under Directive 93/42/EEC or Directive 90/385/EEC and may continue to be placed on the market or put into service under the transitional provisions of the MDR. The term thus describes the regulatory provenance of a product. It does not answer the question of whether the existing clinical data already constitute sufficient evidence under the MDR.
Legal Status During the Transition
The transitional provisions permit, under certain conditions, the continued placing on the market of devices whose conformity assessment was based on the former directives. Prerequisites include, among others, that the device continues to comply with the applicable former directive, undergoes no significant change in design or intended purpose, and presents no unacceptable risk to health or safety.
The status therefore requires active regulatory management rather than mere continuation of old certificates. Manufacturers must take into account the applicable MDR requirements during the transitional phase and plan the pathway to MDR conformity assessment. The Notified Body assesses not only historical documentation but also changes and ongoing post-market surveillance of the device.
Clinical Evidence Under the MDR
For a legacy device, clinical investigation reports, literature, registry data, PMCF data, and further experience from use may contribute to the clinical evaluation. The MDCG classifies such sources according to their evidential weight. What matters is not the age of the data but whether they are sufficient and traceable for the specific intended purpose, the target population, and current safety and performance requirements.
Where gaps exist, targeted subsequent generation of clinical data may become necessary before MDR certification. Particularly relevant is the appraisal against the current state of the art and against available therapeutic alternatives. A device that has been on the market for a long time may therefore still require additional PMCF activities.
The required clinical evidence is not determined schematically by the transitional status. It must fit the characteristics and intended purpose of the individual device. The guidance names, among other things, the identification of safety and performance requirements to be substantiated with clinical data, the target groups, and indications and contraindications for the clinical evaluation.
Information of varying evidential weight may originate from the old certification. A historical investigation report can be valuable if the device, application, and methods remain comparable; where clinical practice has changed, the same source may answer only part of the question. The evidence appraisal must explicitly justify these distinctions.
The clinical evaluation of a legacy device is therefore not a pure migration dossier. It links the former evidence with current data on use, incidents, and available alternatives. Only this integration permits a justified statement as to whether the device continues to substantiate its claimed performance under MDR conditions in a robust manner.
Distinction from Risk Class and Existing Stock
Legacy device is not a risk class. The term merely states that the initial CE marking was based on Directive 93/42/EEC or Directive 90/385/EEC. Devices of different classes may consequently have this transitional status, provided they meet the respective prerequisites.
Nor does the mere fact that an article is located in a warehouse or with a user before a cut-off date make it a legacy device in the regulatory sense. The category is tied to the former legal basis and to the MDR transitional rule. It must not be confused with a general designation for an older product model.
Relevance for clinical trials
Studies on legacy devices are frequently planned where the existing evidence does not answer a specific MDR question: for example, in a patient group now more narrowly defined, in changed clinical practice, or for an endpoint insufficiently substantiated to date. The study protocol must then clearly separate which data originate from earlier use and which evidence is newly generated. The linkage of PMS signals, PMCF objectives, and clinical evaluation prevents open evidence from remaining described only narratively.
Full-service CROs such as Mediconomics support the evidence gap analysis for the MDR transition, the design of PMCF studies, and the preparation of registry or real-world data for clinical evaluation. They align monitoring, data management, and medical writing to ensure that new data address precisely the residual uncertainties identified in the Clinical Evaluation Plan and risk documentation.
Frequently Asked Questions (FAQ)
Are data from the former CE marking always sufficient for the MDR?
No. The data must be sufficient for the MDR evaluation and support the safety and performance profile in relation to the current state of the art.
Can a legacy device continue without MDR-compliant quality management measures?
The transitional provisions tie the continued placing on the market to conditions that include an MDR-compliant quality management system. The status therefore does not arise without ongoing manufacturer obligations.
Is every long-marketed medical device a legacy device?
No. The designation requires the former CE marking under one of the two named directives and the use of the MDR transitional provisions.
Regulatory References
- Regulation (EU) 2017/745, Article 120 – contains the transitional provisions for former certification pathways.
- Regulation (EU) 2023/607 – amended the transitional provisions of the MDR.
- MDCG 2020-6 – addresses the clinical evidence requirements for previously CE-marked devices.
- MDCG 2021-25 Rev.1 – explains which MDR requirements apply during the transitional phase.