Clinical Evaluation Report Requirements Under MDR
Regulation (EU) 2017/745 has expanded the requirements related to Clinical Evaluation and Clinical Investigations with Chapter VI (Articles 61 to 82) covering this area. We take a look at the clinical evaluation report requirements under the MDR to be introduced in May 2021.
Update: You will see that some of our comprehensive MDR content that we have created refers to the May 2020 date of application. The date of MDR application has moved to May 26th, 2021. Articles that were written prior to the delay referenced the earlier date. However, articles that you might read that reference the earlier date should be read taking the new date of May 2021 into consideration. Read more here.
Does A Device Require A Clinical Evaluation Report?
The new MDR requires all Classes of medical devices to have a Clinical Evaluation Report (CER). In addition, MEDED 2.7/1 rev. 4 ‘Clinical Evaluation: A guide for manufacturers and Notified Bodies’ has tightened the process for Clinical evaluation.
MDR Article 61 and Annex XIV outline the requirements of clinical evaluations. In summary, clinical evaluation comprises of a review of relevant scientific literature of the device (provided that the device under evaluation is equivalent to the device to which the data relate); a review of all available clinical investigations data (data generated by the device under evaluation and/or published data); and also considering any current alternative treatment options with the same purpose.
It is also important to note that, MEDED 2.7/1 rev. 4 ‘Clinical Evaluation: A guide for manufacturers and Notified Bodies’ has tightened the process for Clinical evaluation and while this guidance is specific to MDD 94/42/EEC, it should be considered along with MDR requirements.
Compiling A CER
While Article 61 (4) MDR indicates that Class III devices and Implantable devices require a Clinical Investigation –with exceptions as per Article 61 (4) and (6) – it transpires that for all other devices, MDR’s strict requirements regarding demonstrating equivalency between devices under evaluation and comparator devices, make the compilation of a CER quite a challenging task.
Furthermore, in the CER, if the comparator device is a competitor device, then for Class III/Implantable devices, it must be demonstrated that there is full access to the competitor device’s technical documentation – this may necessitate a contract between the manufacturer and that of the competitor device.
Equivalence (between devices) falls under Biological, Clinical and Technical criteria. Criteria for Biological and Clinical equivalency are given in MEDDEV 2.7/1 rev. 4, while technical criteria are broader and must be chosen with regard to the device under evaluation.
On assessment, the Notified Body will question any differences between the device under evaluation and the comparator device from the point of view of clinical safety and performance requirements as established for the main device.
The Need for Clinical Investigations
If Clinical Investigations are required, then the requirements are outlined in Articles 62-82 and Annex XV of the MDR.
Following on from Clinical Evaluation, Annex XIV Part B of the MDR, indicates the requirement for a PMCF process for all medical devices. If manufacturers do not have a PCMF study, they must adequately justify this.
PCMF studies should have a PCMF Evaluation report that should be used to update the CER throughout the lifetime of the device.
Since the timeline for Implementation of MDR is fast approaching, it is important that device manufacturers are ready for the new requirements of Clinical Evaluation.
Steps To Consider For An MDR Compliant CER
- identifying company procedures and documents that concern clinical data
- Conducting a gap analysis between current company procedures and documents vs MDR requirements and implementing any updates needed
- Noting differences in definitions between current MDD and guidances vs MDR and addressing these in current company procedures
- For new devices to be CE marked, planning now for Clinical data requirements
- For legacy devices, devising a Clinical data policy
Are you ready for the new requirements under MDR 2017/245?
We can help you to prepare for the May 2020 deadline. Call us today on 00353 52 61 76 706 or complete the form below and we will get back to you.
Further Reading from Acorn Regulatory
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