Who this service is for, and what you receive
Manufacturers come to us at three points: a first clinical evaluation report for a new device, an update to an existing report, and a report for a device that was certified under the earlier directives and now has to be assessed under the regulation. In each case the report is judged on whether a notified body can follow it from the question to the conclusion without having to trust the author. Our clinical evaluation report writing services therefore deliver the working documents as well as the report:
- A clinical evaluation plan and scope definition, covering the device, its intended purpose, the claims to be supported, and the safety and performance questions the evaluation has to answer.
- A literature search protocol, written and agreed before any search runs, and a literature search report that records how the search was executed, every deviation from the protocol, and the results.
- A state of the art review for the clinical field the device belongs to, with its own search and its own appraisal.
- Appraisal tables for every data set, showing methodological quality, relevance, and the weight given to each, plus the screening log with a reason for every exclusion.
- The report itself, drafted to the MEDDEV 2.7/1 revision 4 structure, with the search and appraisal documentation attached as appendices.
- The curriculum vitae and declaration of interests of the methodologist who signs the literature and appraisal sections.
If your notified body questions the search or the appraisal, we revise the documentation at no charge. Request a scoped quote for your clinical evaluation report and a PhD methodologist will reply with a written scope.
Under the EU Medical Device Regulation (EU MDR), Regulation (EU) 2017/745, the requirement for clinical evaluation sits in Article 61 and Annex XIV. MEDDEV 2.7/1 revision 4, the European Commission guidance published in June 2016 under the earlier device directives, describes the method in five stages. Its approach to the literature search, the appraisal, and the report structure is the one we follow, read together with the regulation and current Medical Device Coordination Group (MDCG) guidance. The table shows who does what at each stage.
| Stage in MEDDEV 2.7/1 revision 4 | What we do | What you provide |
|---|
| Stage 0: scope of the clinical evaluation | Draft the clinical evaluation plan and scope with you, and turn the claims into answerable safety and performance questions | Device description, intended purpose, claims, risk management documents, and any earlier report |
| Stage 1: identification of pertinent data | Write the literature search protocol, run and log the searches, screen the records, retrieve the full texts, and compile the literature search report | The data you generate and hold, such as clinical investigations and post-market surveillance data |
| Stage 2: appraisal of pertinent data | Appraise each data set against a written appraisal plan for methodological quality, relevance, and weight | Answers to technical questions about the device and comparable devices |
| Stage 3: analysis of the clinical data | Analyse the appraised data against the safety, performance, and benefit-risk questions, and identify gaps in the evidence | Clinical specialist input and your risk management conclusions |
| Stage 4: the clinical evaluation report | Draft the report, check it against the plan, and sign the sections we authored | Review, your own evaluators' signatures, and release into the technical documentation |
A literature search your notified body can reproduce
MEDDEV 2.7/1 revision 4 is specific about the search. It is carried out on the basis of a search protocol that documents the planning before execution, and a literature search report then presents the details of the execution, any deviations from the protocol, and the results. The guidance also asks for a comprehensive, documented, and justified strategy that normally involves more than one database. Our medical device literature search follows that sequence without shortcuts.
The protocol frames each question with the PICO structure (population, intervention, comparator, outcome), lists the sources, gives the full search strings, and fixes the selection criteria. We search MEDLINE (PubMed), Scopus, and Web of Science, the trial registries ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform, and the reference lists of the included papers. MEDDEV 2.7/1 revision 4 describes MEDLINE or PubMed as a good starting point and gives Embase (Excerpta Medica) and the Cochrane CENTRAL trials register as examples of additional databases that may be needed for adequate coverage of devices in use in Europe. The source list is agreed and justified in the protocol at scoping, so if your procedure or your notified body calls for a particular additional source, such as Embase with its Emtree thesaurus, that is settled before the work starts.
Two reviewers screen the records against the protocol, every decision is logged record by record, and the numbers are reported in a PRISMA flow diagram. We retrieve the full-text papers ourselves, so you are never asked for library access, and the appraisal is done on full texts, never on abstracts alone. For a search commissioned on its own, see our documented search strategy development.
State of the art review and appraisal of clinical data
The guidance separates two bodies of literature: data on the device under evaluation and any equivalent device, and a review of current knowledge and the state of the art in the clinical field. They answer different questions, so we give each its own search. The state of the art review covers the medical condition, the benchmark devices and medical alternatives available to patients, and the applicable standards and guidance, which together set the safety and performance levels the device is judged against. The device search collects the clinical data that speak directly to the device's own safety and performance.
Before appraisal begins we write an appraisal plan that sets the criteria for methodological quality, for relevance to the device and its intended purpose, and for the weight each data set carries. Every paper is then assessed against that plan on its full text, and the result is recorded in appraisal tables, so an assessor can see why a study was relied on, given limited weight, or set aside. Where the included studies report comparable outcomes, a meta-analysis of performance and safety outcomes gives a pooled estimate in place of a narrative summary, and where the question calls for a full review, the work runs through our PhD-led systematic review service.
Equivalence, legacy devices, and updates
When clinical data from another device are used, MEDDEV 2.7/1 revision 4 requires that clinical, technical and biological characteristics are all taken into consideration for the demonstration of equivalence, and MDCG 2020-5 addresses equivalence under the regulation. We search for and appraise the published data on the proposed equivalent device and document the comparison you supply; the decision to claim equivalence stays with you as the manufacturer. For a legacy device first certified under the directives, MDCG 2020-6 addresses the clinical evidence needed, and we scope the literature work against it.
A clinical evaluation is not written once. The guidance says the report is updated when new post-market information could change the evaluation, and otherwise at least annually if the device carries significant risks or is not yet well established, or every 2 to 5 years if it is not expected to carry significant risks and is well established, with a justification for the interval. Your notified body's expectations govern in practice. For a clinical evaluation report update, we rerun the logged search from the last cut-off date, screen and appraise the new records with the same criteria, and revise the sections of the report they affect.
Post-market clinical follow-up is planned by the manufacturer, and MDCG 2020-7 and MDCG 2020-8 give templates for the plan and the evaluation report. We cover the literature part: the scheduled searches, the screening, and a summary of what the new publications mean for the device. Manufacturers with a medicinal product in the portfolio often pair this with our safety literature screening for marketed products.
Who signs the report, and what stays with you
MEDDEV 2.7/1 revision 4 says the evaluation should be conducted by a suitably qualified individual or a team, and that the manufacturer justifies the choice of evaluators through their qualifications and documented experience and presents a declaration of interests for each. The knowledge it lists falls into two groups. The first is research methodology, information management, regulatory requirements, and medical writing. The second is knowledge of the device technology and of the diagnosis and management of the condition the device addresses.
Our PhD methodologists cover the methodology, the searching, the appraisal, and the writing. The device technology and the clinical expertise usually sit with your engineers and your clinical specialist, who join the evaluation team and sign alongside us. The methodologist who writes the literature and appraisal sections signs them and supplies a curriculum vitae and declaration of interests for your file. Whether the evaluator team as a whole meets the guidance for your device is mapped with you at scoping, so any gap is identified before the work starts and not by the notified body.
Some things are outside the service. We do not run clinical investigations or post-market studies, we do not act as a notified body or an authorised representative, and no writer can promise the outcome of a conformity assessment. What we commit to is a search that can be rerun, an appraisal that can be traced, and a report that says only what the data support.
Related work is handled by the same team: regulatory literature reviews for drug and device dossiers, medical writing for regulatory documents, and translation of foreign-language clinical papers when relevant studies are not in English.
It starts with a scoping conversation. We ask for the device and its class, the intended purpose, whether this is a first report or an update, whether equivalence is claimed, any procedure or template your quality system requires, and what clinical data you already hold. From that we write a scope of work and a fixed quote. A non-disclosure agreement and purchase orders are available on request, and device information is handled confidentially.
Work begins once the quote is accepted and payment or a purchase order is in place, and the delivery schedule is confirmed at that point. Drafts are reviewed with your team at the protocol stage and again at the report stage, so nothing in the final document is a surprise.
If you want the method explained before you commission anything, read our guide to the clinical evaluation report literature review.