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Post-Market Clinical Follow-Up (PMCF)

PMCF Study Services Under EU MDR:
Ensure Compliance & Market Access

Collect real-world clinical data to confirm your medical device's performance, safety, and regulatory compliance.

EU MDR Compliant

ISO 14155 & MEDDEV 2.12/2

Real-World Evidence

Scientifically valid data

Fast & Efficient

12-month average timeline

EU MDR Requirements

What Are the Key Changes Under the MDR
for Post-Market Clinical Follow-Up?

The EU MDR introduces stricter PMCF requirements to ensure continuous monitoring of medical device safety and performance.

Key Changes Under the MDR

  • ✓ Strengthening of PMCF requirements by including specific requirements in the regulation text instead of guidance documents
  • ✓ Specifying required elements of the PMCF plan (protocol, data collection methods, objectives)
  • ✓ Mandatory methods and procedures for clinical data collection and analysis
  • ✓ Clear definition of PMCF objectives aligned with device risk classification

From MDD to MDR: What Changed?

Under the Medical Device Directives (MDD), PMCF was mentioned only three times across Annex II (EC Declaration of Conformity), section 5 (Surveillance), and Annex X (Clinical Evaluation). The MDD did not define PMCF, only stating it was part of post-market surveillance that could be waived if "duly justified and documented."

MEDDEV 2.7/1 Guidelines (Rev. 4, June 2016)

The MEDDEV 2.7/1 Guidelines provide detailed definitions for PMCF plans and PMCF studies, clarifying that PMCF studies are:

  • Systematic and methodologically rigorous
  • Designed to estimate residual risks and uncertainties
  • Focus on rare complications, long-term performance, and safety under wide-spread use

⚠️ Important: PMCF is now mandatory under EU MDR for all medical devices

Failure to conduct compliant PMCF studies can result in CE marking suspension or withdrawal.

🎥 Webinar Replay

Master PMCF Under the MDR:
Notified Body Insights & Survey Best Practices

Watch the full 60-minute expert session and learn how to avoid costly CER rejections with strategic PMCF implementation.

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Client Success Stories

Trusted by Leading MedTech Companies

Discover how we've helped medical device manufacturers achieve PMCF excellence and regulatory compliance across Europe.

Asahi Intecc

Asahi Intecc

Global leader in medical guidewires and catheters

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Unither Pharma

Unither Pharma

Leading pharmaceutical manufacturing specialist

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Nihon Kohden

Nihon Kohden

Pioneer in medical electronic equipment

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RegenLab

RegenLab

Innovator in regenerative medicine solutions

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Gentell

Gentell

Advanced wound care and skin health solutions

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👥 Expert Team

Which Eclevar Team Is in Charge of the PMCF?

Our team is led by former notified body and competent authority leadership. They have significantly contributed to MDCG guidance documents on clinical evaluation, sufficient clinical evidence, and PMCF. They were also involved in the development of the requirements of MEDDEV 2.7/1 rev 4, which are now reflected in the MDR.

Former Notified Body Leadership

MDCG Guidance Contributors

MEDDEV 2.7/1 Rev 4 Authors

Expert Team

Your Dedicated PMCF Team

Expert professionals ensuring the success of your Post-Market Clinical Follow-up studies

Guillaume Charles

Guillaume Charles

Feasibility & Site Partnerships

Expert in site selection and partnership management

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Karina Schönborn

Karina Schönborn

Lead Clinical Research Associate

Leading clinical monitoring and site management

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Charline Petitdemange

Charline Petitdemange

Project Manager

Expert in clinical trial management and coordination

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Pierre-Marie Boutanquoi

Pierre-Marie Boutanquoi

Head of Medical Writing

PhD expert in EU MDR, CER, and PMCF documentation

LinkedIn
Our PMCF Services

Our Services of PMCF Post-Market Clinical Follow-Up

The aims of collecting RWE data as part of PMCF activities are:

  • ✓ Study population that represents the entire population indicated in the IFU.
  • ✓ Does not involve experimental exposure.
  • ✓ Aiming to cover the "entire lifetime of the device"
  • ✓ Is conducted at all types of clinical site, not just specialist units

Why PMCF Is Critical for Long-Term Safety

At the end of a clinical trial, there is usually limited knowledge of the medium and long-term safety and performance of the device.

The medium- and longer-term safety and performance of a device is estimated on the basis of premarket trial durations, that are generally inadequate to validate extrapolation hypothesis in real life, particularly implant longevity hypotheses.

Case Studies

Our PMCF Case Studies

Real-world evidence demonstrating clinical excellence and regulatory compliance

RWE multicenter using PMCF for data collection

Registry Proxy with French Data health hub

As shown by the Clinical Evaluation Report, intended claims on clinical safety and performance are not sufficiently supported with existing clinical evidence. In order to maintain "Vascular device" in the European market, client has to conduct a PMCF study to generate sufficient clinical data in accordance with "Chapter VI – Clinical Evaluation and Clinical Investigations, specifically sections 62 – 82". As well as ISO 14155:2020

Objectives

  • • Confirming safety and performance of the Vascular device throughout its expected lifetime and both anatomic location: Carotid and femoral.
  • • Identifying and analyzing emergent risks on the basis of factual evidence;
  • • Ensuring the continued acceptability of the benefit-risk ratio referred to in EU MDR
  • • Identifying possible systematic misuse or off-label use of device X, with a view to verifying that the intended purpose is correct.

Methodology

A Sponsor conducted RWE multicentre study to collect clinical data for Vascular device. The objective was to examine short and long-term outcomes of using the device when exposed to a larger and more varied population.

All data were retrieved from medical charts for each patient from time of surgery (considered as baseline of study) until a maximum of 3 years after surgery.

300 subjects were evaluated from 3 different sites. 150 subjects were evaluated in carotid location and at least 150 in femoral location.

Benefits

  • • Contribute to a larger body of evidence being developed:
  • • Representative population
  • • Accepted by the notified body for MDR certificate.

Limitation: Incomplete long-term evidence.

Solution: Implementation of European vascular registry

Need Help with Your PMCF Study?

Our expert team can guide you through every step of your Post-Market Clinical Follow-up, from study design to regulatory submission.

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🎬 Expert Presentation

PMCF Under the MDR:
Insights from Our CEO

Watch Chems HACHANI, CEO of Eclevar MedTech, explain the key strategies for successful PMCF implementation under the EU MDR.

Chems HACHANI
CEO & Founder, Eclevar MedTech
15+ years in medical device clinical research

⏱️ Duration: 60 minutes

Patient surveys: These are probably the most utilised tool seen at the moment.

Surveys offer a degree of flexibility

Surveys offer a degree of flexibility, they can be general but also designed to be highly specific – they can meet a wide range of needs in data generation.

General surveys tend to be retrospective design – asking the end-user to recall information on the device and its use.

Specific surveys can be patient level and case specific – this can be a single survey or a series of surveys that follow the usage of the devices (prospective). This could be direct to the patient or via a healthcare professional using patient records. The data obtained from this type of activity will be of higher quality – usually producing clinical data on the devices under review via patient outcome data and clinical indication data.

They also are considered relatively easy to design and conduct.

However, they should be used appropriately and as with all the activities their use needs to be justified within the PMCF plan.

Challenges:

  • Access to the end-users – this can be limited /restricted e.g. if a distributor is used.
  • Bias – the structure of the survey is important in minimizing bias. More of a concern with subjective healthcare professional responses.
  • Lack of responses – the survey needs to be accessible and simple to complete. Users may get 'fatigue' in completing them if they are too long, too complicated or not relevant.
  • Loss of focus – as set out above the survey needs a clear direction – if too many objectives are attempted the survey may not be clear enough, and the data returned may be skewed.
  • GDPR compliance is critical
  • Ethical review and approval may be required – individual countries may have different requirements.

Investigator initiated studies: Often seen as another useful tool, as much of design and conduct

Challenges:

Limited control over conduct or data sets

Potentially there may be extra cost if you chose and are able to take an active role.

There is less assurance that you are getting the true data – the true picture of safety and performance.

Regulatory Guidance

What is the Notified Body's role?

Understanding key review points and regulatory requirements

There is a significant increase in scrutiny by the NB under the new regulations. There are key timepoints at which the NB is likely to review your PMCF plan and data:

  • • During initial conformity assessment
  • • If you submit a significant change review
  • • Recertification
  • • Unannounced audit – PSQP or your PSMR
  • • Routine review – e.g. annually for class III and implantable products
  • • Don't forget the Competent Authorities can also request the data – it needs to be done and available as set out in the PMS plan.

This is not an exhaustive list – just the key points of review – again it is a demonstration of that lifecycle approach and that consistent review across that lifecycle.

It is not just a box to tick – it is a critical function that will build the knowledge of your device, allowing for that reassurance that your product continues to perform and that the benefit risk ratio continues to be acceptable and risks are mitigated as far as possible.

Relevant guidance:

MDCG 2021-4 Q&A on clinical investigations

MEDDEV 2.12/2 – Post Market clinical follow up studies

Eclevar has an international team of leading KOLs at leading hospital sites across all key therapeutic areas who provide medical oversight and expertise to projects.

Other key considerations for the selection of a partner for joint medical device & diagnostic CRO:

Quality

The quality of work is directly linked to compliance with the regulation. It is important to ensure that the medical device CRO or IVD CRO holds the relevant quality standard documents ISO14155 (European regulation), ISO9001, and ISO13485.

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Clinical trial Capabilities

Does the clinical research organization have global capabilities and partnerships for the regions where the study will be performed in? Studies can involve working with several vendors so having the full-service capabilities of a clinical research organization will help. Is the CRO able to provide a full-service approach, including providing a CTMS (clinical trial management system)?

Cost

This can be key factor in selecting a clinical research organization. Comparison with other CROs needs to be comparable (i.e apples with apples) such as comparing unit costs/line items and not overall cost. Does the CRO provide transparency around pass-through costs which can often impact the cost of the clinical trial or PMCF study? If the project costs look very low have all the study specifications included as in future costs may increase significantly with multiple pass-through costs.

This process can be assisted by the process for setting the right expectations when assessing clinical research organizations in the process of RFI(request for information) and/or RFP. Implementing a standard comparison process can provide the same set of questions and scope of work for medical device CROs to respond.

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