How the CER and the PMCF Plan are related with each other?
Under the EU MDR, the PMCF Plan is a part of technical files that need to be submitted to the NB when submitting the CER to the NB. The PMCF Plan is a document that describes how to address any data deficiencies identified in the CER and/or to continuously monitor the safety and performance of the medical device in question throughout its expected lifetime.
The PMCF Plan and its schedule need to be justified in light of the nature of the device and its clinical evidence level according to the EU MDR and other relevant regulations and guidelines.
What would happen if you failed to update the CER according to the required timeline or the timeline agreed with the NB?
The consequence can be serious depending on the situation you are in. For example, supposing you are still in the transition process from the MDD to MDR and your device is lacking sufficient clinical evidence for certain indications, for which you submitted the PMCF Plan to collect clinical data for the indication and update the CER with the PMCF Report in one year, if you fail to submit the PMCF Report and the update CER as agreed with the NB.
Potential Consequences:
- Suspension of the CE renewal
- Product suspension from the market
- Loss of regulatory compliance status
- Damage to manufacturer reputation
Best Practice:
Thus, when you prepare the PMCF Plan, you need to carefully take it into consideration of feasibility of your PMCF plan including timeline for the PMCF report. In some case, you may need to submit the interim PMCF report instead in case the PMCF has not been completed as planned at the time of reporting. This way would prevent you from failing to report the PMCF report.
Are there any tips for updating the CER?
1. Prepare a New PMCF Plan
At first, when you updated the CER, you will also need to prepare the new PMCF Plan to address any data deficiency or insufficiency.
2. Demonstrate Thorough Evaluation
Secondly, the CER needs to be thorough, and it is highly recommended to demonstrate the fact you have done the thorough evaluation. For example, it is better to include all tables to show that you have done your work to search safety issues such as adverse events for your device on the literatures even if there are no adverse events found. Doing so would give impression to the NB that you have done the thorough evaluation.
3. Conduct Systematic Literature Search
Finally, as for the literature search, it must be systematic search. No handpick search is acceptable. The literature search needs to be reproducible, which means that the NB can get the same result with using the literature search protocol used in the CER.
Meet Our CER Expert
Pierre-Marie Boutanquoi
Head of Medical Writing
Pierre-Marie brings extensive expertise in Clinical Evaluation Reports (CER) and Post-Market Clinical Follow-up (PMCF) under the EU MDR. With deep knowledge of regulatory requirements and notified body expectations, he leads our medical writing team in delivering robust, compliant CERs that meet the highest standards of scientific rigor.
His experience spans multiple device classes and therapeutic areas, ensuring that manufacturers receive expert guidance tailored to their specific regulatory challenges and timelines.
Expertise: Clinical Evaluation Reports (CER), PMCF Plans & Reports, EU MDR compliance, Literature reviews, Risk-benefit analysis, Notified Body submissions
What Eclevar Medtech can support you on?
The CER required by EU MDR is highly sophisticated and much more complex compared to the one under the MDD. Therefore, it requires advanced medical writing expertise to formulate and write the robust CER.
Eclevar is a CRO specialized in the medtech industries and has experienced medical writing team and medical experts to provide consultations according to your needs in complying with EU MDR. If you have any questions or need support, please feel free to contact us at: clientcare@eclevar.com.
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