Common Gaps in Clinical Evaluation Reports and Technical Documentation under the MDR
An Overview
Clinical Evaluation
Medical device manufacturers perform various daily tasks, and consistent compliance with the MDR for technical documentation is a time-consuming challenge. CLIN-R+ is here to help you analyse and identify potential gaps in Clinical Evaluation Reports and technical documentation (such as Design Dossiers and Technical Files).
The first step toward planning a route to MDR compliance is to be aware of any compliance gaps. Therefore, we’d like to highlight some common gaps in clinical evaluation reports and technical documentation when transitioning from the MDD to the MDR.
Common Gaps in Clinical Evaluation Reports
Lack of Clinical Evaluation Plans (CEPs)
According to Annex XIV, manufacturers must create and maintain a clinical evaluation plan (CEP). This must include the appropriate scope of the clinical information supplied, and criteria for how this will be assessed. MEDDEV 2.7/1 Rev. 4 also requires this CEP as evidence of the planning step for a CER, which is often absent.
Establishing Equivalence
In addition to the MDR, MEDDEV 2.7/1 has had stringent updates to the requirements for demonstrating equivalence under Revision 4.
You must meet all requirements to demonstrate full clinical/biological/technical equivalence in device characteristics.
There are also key points manufacturers should consider, which are often gaps in clinical evaluation reports:
- If you established equivalence with a competitor device, the Notified Body will request access to the competitor’s technical documentation device. Under the MDR, a Class III/implantable device must have a contract with the analogous device’s owner or full access to its technical documentation.
In most circumstances, access to proprietary information isn’t possible, so manufacturers will have to re-evaluate their equivalency strategy. This could mean using different types of clinical data or using your own devices to prove equivalent. - If you completed the equivalence route using your own devices (or if a contract exists between two manufacturers of the comparator devices), then MEDDEV 2.7/1 Rev. 4 states the requirements for biological and clinical equivalence. You must define how the technical criteria are broader case by case for the evaluated device.
- The manufacturer must justify the specific technical criteria chosen to justify equivalent design and critical performance specifications. By using
product-specific standards, for example.
You shouldn’t substitute the FDA-mandated “substantial equivalence” table in place of a CER. This differs from determining equivalence under MDR or MEDDEV 2.7/1 Rev. 4 requirements. - You should provide a table of the specific clinical, technical, and biological criteria after the technical criteria are clear and justified. The Notified Body will question clinical safety and performance differences for the main device (the subject of the CER). If you used the same test method, they’ll ask where the comparator information originated from. A medical professional must justify the clinical significance of a significant result deviation.
Literature Search Strategies
Manufacturers need to fully develop the literature search strategies per MEDDEV 2.7/1 Rev. 4. They should also consider specifics, such as using PICO(T)/MOOSE methodology in developing search terms, demonstrating Boolean logic in search strings, and including provisions that specify how the articles are weighed.
The individual responsible for performing the literature searches should also be listed, and they should possess all the expertise required under MEDDEV 2.7/1 Rev. 4.
The CER can include a PDF file of the literature search to explain how the search was conducted and the findings, making the search repeatable.
Post-Market Clinical Follow-Up (PMCF)
Every medical device (Class I and up) needs a PMCF process as per Annex XIV Part B. The PMCF output needs to include specific activities (examples are given in Annex XIV Part B 6.2 a and b).
Manufacturers must provide appropriate justifications for not conducting a PMCF study (per Annex III).
A PMCF study is also needed for Class III and implants that have relied on equivalence to not perform clinical investigations, under the MDR (Art 61(4)). A PMCF Evaluation Report should be created for all PMCF studies. Its information should be used to update the CER throughout the lifetime of the device.
Many medical device manufacturers haven’t caught up with these requirements yet. When performing gap analyses, this becomes apparent. Many PMS/PMCF plans and reports either don’t exist or have significant shortcomings to the new requirements.
Technical Documentation
In addition to gaps in Clinical Evaluation Report, the common gaps in Technical Documentation include:
Additional Details Required under MDR
Additional information for manufacturing and supplier steps, full analysis and results of testing summarised in the technical file, and full descriptions of device compatibility and/or accessories to the medical device.
The Format of the Technical Files and Declarations of Conformity
We must update this according to the MDR (including Annex I, II, III and IV).
The Essential Requirements Checklist
We must update this to MDR (Safety and Performance Requirements Checklist), with special attention to be paid to:
- GSPR 13.1 and 13.2 respectively, regarding additional requirements for devices that may contain derivatives of animal origin.
- Instructions for Use (IFUs) and labelling should be updated to conform to GSPR 23. EU-UDI requirements must also be incorporated in both the Technical Documentation and the labelling/IFU.
- GSPR 10.4 on Hazardous Substances stands out in particular. It now requires extensive justification of potential patient or user exposure to the/any Carcinogenic, Mutagenic or toxic to Reproduction (CMR substances) or endocrine-disruptor substances in certain devices.
Many elements from the MDR and MEDDEV 2.7/1 Rev. 4 now require additional attention from medical device manufacturers, among many others.
CLIN-r+ Recommendations
Medical device producers will face stricter regulations due to the introduction of EU MDR.
This impacts more than the Clinical Evaluation workflow. Getting experienced CER writers and consultants early reduces the gaps in clinical evaluation reports and boosts the likelihood of a successful NB audit. It also saves resources and time, so the manufacturer can focus on other areas.
As the Clinical Evaluation is a key workflow that automatically audits your QMS system and highlights areas of concern, it’s the most efficient and cost-effective area to bring in skilled experts. Experienced CER consultants will not only identify problems upstream, but also advise on solutions, best practices deployed by the medical device industry, and efficient workflows to overcome problems later on. Consultancies also come with resources such as systematic review software, access to literature databases, and industry expert reviewers, helping expand your companies’ capabilities cost effectively.
Consider partnering with a consultancy to also undertake the maintenance of your CER, as the work isn’t finished after certification is granted. CLIN-r+ can periodically update documents and create reports, as required by classification and/or as new data arises. Investing in continuing maintenance also helps streamline risk management and SSCP updates, as well as the creation of PSURs. This will ensure you are always in compliance.
To learn more about CLIN-r+ Clinical Evaluation services for medical devices and IVD manufacturers, get in touch!
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