Clinical Investigations and PMCF Studies under the MDR: Correct Classification and Application
How to accurately assess the time and cost involved in applications and how to quickly and efficiently generate missing clinical data.
The MDR has significantly tightened the requirements for clinical data. This is particularly true for Class III and implantable medical devices, as well as for those whose conformity relies on data from equivalent devices.
If the existing clinical data for the device is insufficient, the manufacturer is required to generate it through clinical trials or PMCF activities. Planning, conducting, and applying for clinical trials are time-consuming and costly, and the regulatory requirements are complex.
Accurately assessing the effort is crucial for manufacturers. An unnecessary clinical trial can be a financial challenge, especially for small and medium-sized enterprises. Conversely, a necessary clinical trial that is not conducted, delayed, or incompletely applied for can jeopardize the legal marketing of the devices.
But what applies to PMCF studies conducted within the scope of the intended purpose?
Where should these be classified? Do such studies also require an ethical review or even an approval process under the MDR?
This article describes:
- The types of clinical trials and post-market clinical follow-up (PMCF) studies,
- The questions they can address,
- Where they fit in the product lifecycle,
- The regulatory requirements that must be considered in the application, and
- The expected time to study commencement.
We also clarify the classification of studies not regulated by the MDR and MPDG, such as feasibility studies and PMCF studies, and highlight what differentiates them from clinical investigations.
The good news upfront: The application for PMCF studies conducted within the scope of the intended purpose without additional invasive or burdensome procedures, remains straightforward under the MDR and can – once all required documents aresubmitted of - begin in just over a month.
1. Clinical Investigations Regulated by MDR and MPDG
Clinical Investigations Before CE Marking
For clinical trials conducted prior to CE marking, the safety of the investigational device must be fundamentally demonstrated.
Clinical Investigations
A ‘clinical investigation’ is defined as “any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device” 1
Clinical Investigation in the Narrower Sense
Clinical investigations in the narrower sense are conducted to demonstrate conformity. Their goal is to determine that the medical device, under the proposed conditions of use, performs as specified by the manufacturer, is safe, and achieves the desired clinical benefit. 2 Clinical trials in the narrower sense are typically sponsored by the manufacturer.
Regulatory Requirements
In principle, all forms of trials and studies must follow a sequential application process. This involves first obtaining approval from the ethics committee, followed by validation of the notification or completition of the approval process by the federal authority.
Notification or Full Approval Procedure?
Clinical trials in the narrower sense require approval from the ethics committee and notification orapproval by the authority (BfArM). In Germany, after a positive ethics vote, clinical trials involving Class I or non-invasive Class IIa devices can commence upon validation of the application by the authority. For all other devices, the full approval procedure must be completed before trials can begin. 3
Attention:
The offers a greater degree of flexibility, which has been more narrowly interpreted nationally by the MPDG.
Depending on the completeness of the submitted documents, the time required to study commencement is approximately 2-6 months for Class I or non-invasive Class IIa devices, and approximately 4-8 months for all other devices.
Other Clinical Investigations
The term ‘other clinical investigations’ is not explicitly defined in the MDR. However, the MPDG distinguishes theseinvestigations from clinical investigations in the narrower sense.
An ‘other clinical investigations’
- is not part of a systematic and planned process for product development or monitoring by a current or future manufacturer,
- is not conducted with the aim of demonstrating the device’s conformity with the requirements of the MDR,
- serves to answer scientific or other questions, and
- occurs outside the scope of a clinical development plan as outlined in Annex XIV Part A Section 1(a) of the MDR. 4
As a result, an ‘other clinical investigations’ are typically sponsored by research institutions rather than manufacturers.
Regulatory Requirements
For ‘other clinical investigations’ conducted before CE certification, approval from the ethics committee and notification to the federal authority are mandatory.
The timeline to study depending on the completeness of the submitted documents and is typically around 2-6 months.
| Type of investigation | Goal | Position in Product Lifecycle | Regulatory Requirements/ Time Required |
|---|---|---|---|
| Clinical investigations in the narrower sense according to MDR, Art. 62 (1) | Safety, benefit, and performance for demonstrating conformity | Before CE marking |
Approval of ethics committee (45-110 days) Notification requirement for Class I or non-invasive Class IIa devices (+10-57 days) Approval requirement for all other devices (+65-122 days) |
| Other clinical investigations according to MPDG §47 | Basic Research | Before CE marking | Approval of ethics committee (45-110 days) Notification requirement to the authority (+10-57 days) |
Clinical Investigations After CE Marking
Post-market clinical investigations
Two specific types of investigations conducted after a device has been placed on the market are also classified as clinical investigations under MDR Article 74. These include investigations conducted within the intended purpose, where participants undergo additional invasive and/or burdensome procedures (1), as well as those conducted outside the intended purpose (2). 5
Regulatory Requirements
The regulatory requirements for the application are similar to those for other clinical investigations before CE certification, and include obtaining approval from the ethics committee and providing notification to the federal authority. Depending on the completeness of the submitted documents, the estimated time to study commencement is approximately 2-6 months:
|
Type of Investigation |
Goal | Position in Product Lifecycle | Regulatory Requirements/ Time required |
|---|---|---|---|
| Clinical investigations with a device which already bears the CE marking according to MDR, Art. 74 (2) | Extension of the intended purpose | After CE marking | Approval of ethics committee (45-110 days) Notification requirement to the authority (+10-57 days) |
| Clinical investigations with a device bearing the CE marking within the intended purpose involving additional invasive or burdensome procedures according to MDR Article 74 (1) | Confirmation of safety, benefit, and performance as well as for confirming claims | After CE marking | Approval of ethics committee (45-110 days) Notification requirement to the authority (+10-57 days) |
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2. Non-regulated "studies" not covered by MDR and MPDG
PMCF and feasibility studies
Studies sponsored by the manufacturer, conducted within the framework of product development using a safe investigational device- such as feasibility studies and PMCF studies conducted within the intended purpose without additional invasive or burdensome procedures- do not fall under the definitions of clinical investigations or other clinical investigations. This is because they are part of the product development or product observation for a (future) manufacturer.
Although PMCF studies are explicitly required in Annex XIV Part B of the MDR, neither PMCF studies nor feasibility studies are defined or regulated in the MDR or the MPDG. The term "study" continues to be used for these types of investigations in the MDR. Because these forms generally have lower regulatory requirements compared to clinical investigations, they are further referred to as feasibility or PMCF "studies" in the narrower sense.
Attention:
Manufacturer-sponsored studies conducted as part of product development, such as feasibility studies, and PMCF studies conducted within the intended purpose without additional invasive or burdensome procedures, are neither regulated nor defined in the MDR or the MPDG. This ambiguity in terminology and differentiation from clinical investigations has led to uncertainties in assessing the time and cost involved in the application process.
Regulatory Requirements
For feasibility studies and PMCF studies in the narrower sense, there is no requirement to obtain ethics approval or to notify the competent federal authority. However, the ethics committee still has the responsibility to advise manufacturers before commencement regarding ethical and professional considerations (e.g., in the collection of pseudonymized data) and to provide a written opinion. Professional advice under §15 of the professional code for physicians is intended for this purpose. If already anonymized data/biomaterials are being evaluated, consultation is generally not required.
PMCF studies are particularly suitable for devices that have been on the market for a long time with proven technologies, as they offer a quick and low-effort way to generate any missing clinical data.
| Type of Investigation | Goal | Position in Product Lifecyle | Regulatory Requirements/ Time required |
|---|---|---|---|
| Manufacturer-sponsored studies conducted as part of product development | Feasibility study | Before CE marking | Professional advice by ethics committee under §15 of the professional code of for physicians (35-60 days) |
| PMCF studies with a device bearing the CE marking conducted within the intended purpose without additional invasive or burdensome procedures | Confirmation of safety, benefit, and performance as well as for confirming claims | After CE marking | Professional advice by ethics committee under §15 of the professional code for physicians (35-60 days) |
3. Summary
Due to their different objectives and positions in the lifecycle, various types of clinical investigations and PMCF studies are subject to different regulatory requirements, which involve varying time and cost commitments.
While the application for a clinical investigation conducted for conformity assessment can take approximately 2-8 months depending on the completeness and quality of the submitted documentation and the risk class, a clinical investigation with a device already CE certified, aimed at extending the intended purpose or involving additional invasive and/or burdensome procedures, typically takes about 2-6 months.
PMCF studies in the narrower sense, i.e., those conducted within the intended purpose without additional invasive and/or burdensome procedures, only require consultation under §15 of the professional code for physicians from the ethics committee if pseudonymized data is to be collected.
The following graphic serves to plan the clinical strategy for your devices and estimate the time required for application in various clinical investigations and studies:
4. Conclusion and Recommendation
While it is crucial to plan the clinical strategy early and precisely, especially for new developments, implantable devices, Class III devices, and when seeking an extension of the intended purpose, missing clinical data for lower-risk class devices that have been on the market for a long time can be quickly and easily obtained through PMCF studies.
Plan the clinical strategy for your devices now and:
- Assess in advance whether the existing clinical data for your device is sufficient under the MDR to demonstrate its safety, performance, and clinical benefit.
- Determine which type of clinical investigation/PMCF study is suitable or adequate for your device and your objectives.
- Understand the regulatory requirements you need to comply with when applying under the MDR, what a complete application must contain, and the timelines and costs involved.
- Apply for the studies early to avoid jeopardizing the compliant marketing of your devices.
References:
- MDR, Art. 2 (45)
- MDR, Art. 62 (1)
- 31 MPDG
- 3 MPDG
- MDR, Art. 74 (1, 2)
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