The EU MDR introduces stricter PMCF requirements to ensure continuous monitoring of medical device safety and performance.
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."
The MEDDEV 2.7/1 Guidelines provide detailed definitions for PMCF plans and PMCF studies, clarifying that PMCF studies are:
⚠️ 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.
Watch the full 60-minute expert session and learn how to avoid costly CER rejections with strategic PMCF implementation.
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The aims of collecting RWE data as part of PMCF activities are:
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
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.
Limitation: Incomplete long-term evidence.
Solution: Implementation of European vascular registry
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
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:
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.
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.
MDCG 2021-4 Q&A on clinical investigations
MEDDEV 2.12/2 – Post Market clinical follow up studies
Other key considerations for the selection of a partner for joint medical device & diagnostic CRO:
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.
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)?
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.
