Following a four-year transition period, MDR finally became fully applicable on 26 May 2021. Since this date, clinical evaluations for novel medical devices are required to solely fulfil the requirements of MDR, whilst legacy devices still holding a certificate issued under MDD have an additional grace period. That said, the clinical evaluations for legacy devices will need to be updated in order to comply with MDR and stay on the market.

In our article below, our Head of Clinical Dr Barbara Widmann shares five useful tips to help navigate the modification of your CERs to comply with the MDR.

1. Start off on the right foot

It may seem obvious, but to ensure that your CER is acceptable from a regulatory perspective, you must first understand which regulations you need to adhere to within which time frames:

• Novel medical devices – Clinical evaluations need to solely fulfil MDR requirements since 26 May 2021
• Legacy medical devices holding a certificate issued under MDD – Additional grace period until 26 May 2024 to comply with the new regulation, as long as no significant design or intended use changes are to be implemented to the device (see here for a detailed definition of what constitutes a significant change)

As there is no grand-fathering provision in the MDR, all legacy devices need to be re-certified in accordance with MDR by the end of the grace period.

During the re-certification of legacy devices, clinical evaluation reports (CERs) must be updated from complying with MDD and MEDDEV 2.7/1 rev 4 to the generally higher standard of the MDR.

2. Don’t combine MDD and MDR requirements

When you are updating your CER for a legacy device, it is important to fully transition your report from what was required under MDD, to what is needed under MDR. Whilst under MDD conformity with the Essential Requirements needed to be demonstrated, under the MDR, conformity with relevant general safety and performance requirements needs to be established with clinical evidence (see Annex I, MDR for more on these GSPRs).

As such, it is necessary to clearly define the applicable regulation for each CER before you commence the modification of your report. It is advisable to avoid combining MDD and MDR requirements for legacy devices in the one CER.

When it comes to new medical devices, given that CE certificates under MDD can no longer be issued, the Essential Requirements are again irrelevant and should therefore not be mentioned in your respective CER.

3. Structure your CER correctly

With MDR now the sole legislation for registration of medical devices in the EU, it is crucial that the template used for your CERs is in line with this regulation. Unfortunately, an official template for a CER under the MDR is not currently available, and MEDDEV 2.7/1 rev. 4 has not been updated to reflect the changes required by the MDR.

As MEDDEV 2.7/1 rev. 4 was written with respect to MDD in order to provide practical guidance on conducting a clinical evaluation, bear in mind that only certain sections of this guidance are relevant to the MDR (see Appendix I, MDCG 2020-6 for more information).

Therefore, if you have previously used a CER template for your report that adheres to MDD, you need to update it to reflect the requirements of the MDR. And since there is no CER template available for MDR, it may be useful to refer to the Clinical Evaluation Assessment Report (CEAR) template for notified bodies within MDCG 2020-13 during the preparation of your CER.

4. Clearly articulate your demonstration of equivalence

Demonstration of equivalence may allow you to use clinical data from an equivalent device in the clinical evaluation of the device under assessment to prove its conformity with relevant GSPRs. If you choose to follow the equivalence route for your clinical evaluation, this should be stated in your CER, with the equivalence between devices clearly established.

Remember that under MDR, to base your clinical evaluation on the safety and performance of an equivalent device, it is vital that as the manufacturer, you have access to the complete technical documentation of the equivalent device. This is often only the case if both devices share the same manufacturer.

As your CER should be written as a standalone document, it is important to include a detailed description of the equivalent device. The reviewer needs to be able to understand if the devices are indeed equivalent and why by solely reviewing the CER. MDCG 2020-5 provides guidance that focusses on the demonstration of equivalence under MDR, including a table that can be used to help identify supporting data on a device-by-device basis.

Importantly, the guidance outlines that:

“The manufacturer should identify differences and place emphasis on the differences between the two devices rather than the similarities.”

Existing differences must be discussed, and if necessary, be supported by relevant data to demonstrate that no clinically significant differences arise in safety and clinical performance of the equivalent devices. In this context it should be noted that changes between devices that are considered improvements need to also be critically discussed and substantiated with clinical data.

5. Provide sufficient clinical evidence

One of the main intentions of the MDR is to ensure that manufacturers provide actual clinical data for the medical devices under evaluation to confirm their intended performance and safe use as well as clinical claims throughout their lifetime. This is especially true for new medical devices, yet there seems to be a little more flexibility for legacy devices that hold previous MDD certification.

Therefore, the most challenging task when planning and conducting a clinical evaluation under MDR is defining what is sufficient clinical evidence for the device in discussion that will help to conform to the relevant GSPRs.

When collating your clinical evidence, thoroughness and relevance are key. To this end, you should ensure that all indications and all device versions included in your CER are covered by the clinical evidence provided. Furthermore, when providing clinical evidence to demonstrate conformity with GSPRs, you should ensure the relevance of both the quality and quantity of the clinical data available for your medical devices. For example, if pivotal evidence is required for a novel CE-certification, a simple market survey will not be sufficient.

Moreover, the design of the studies used to demonstrate safety and performance needs to be robust. For example, pre-defined hard endpoints may be required for novel devices as opposed to user surveys that might be used to support a device that has been on the market for a long time.

And finally for legacy devices, depending on the amount of clinical evidence available, the risk level of the device and its market history, remaining gaps in clinical data may be filled by PMCF data as soon as possible after CE-marking. MDCG 2020-6 provides more guidance on legacy devices regarding what might constitute sufficient clinical evidence for demonstration of conformity with relevant GSPRs.

Should you have a challenge relating to clinical evaluation, our Clinical team is ready and happy to help. Simply get in touch to start the conversation.