MEDDEV 2.7/1 Rev 4 - Significant Changes - CER Support

Sep 22, 2026

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MEDDEV 2.7.1 Rev 4 outlines substantial updates for clinical evaluation requirements under the EU market framework, increasing prescriptiveness and the quantity and quality of information expected in CERs. Manufacturers must strengthen areas including Clinical Evaluation Plan structure, CER update frequency, evaluator qualifications, equivalence assessment, and state-of-the-art evidence. R&Q supports compliance through strategic planning, CER assessments, plan and report templates, and literature reviews covering safety, performance, and state of the art.

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MEDDEV 2.7/1 Rev 4 Overview

Significant changes to CER requirements

R&Q support services and deliverables

CER experience by therapeutic area

Supporting tools and process

M E D D E V 2 . 7 / 1 R E V 4 & C E R s The new revision of MEDDEV 2.7.1 was published June 29, 2016. The changes from Rev 3 to Rev 4 are substantial. Most manufacturers who sell into the EU market will require significant effort to update CERs to meet the new requirements. Rev 4 is more prescriptive and requires manufacturers to provide greater quantity and quality of information for clinical evaluations. At the same time, the guideline now includes additional expectations in terms of equivalence and the data used to establish equivalence and adds increased requirements for the expertise of the eval uators. S I G N I F I C A N T C H A N G E S Significant changes to MEDDEV 2.7/1 Rev 4 include: Clinical Evaluation Plan Frequency of CER updates Evaluator qualifications Equivalence State of the art R & Q CA N H E L P R&Q can help you meet the requirements of MEDDEV 2.7.1 Rev 4 with strategic planning and hands-on support. Our services deliver business-balanced solutions that are right for your business. Our services include: CER Assessment: Conduct an assessment between the company’s device or family of devices and the requirements of MEDDEV 2.7/1 Rev 4 and develop a report that will define and prioritize the risks facing the company, and provide recommendations on when and how to mitigate the risks. Clinical Evaluation Plan Strategy: Create a Clinical Evaluation Plan (CEP) strategy outlining key elements to consider for the Clinical Evaluation Report to meet the requirements of MEDDEV 2.7/1 rev. 4 and EU MDR. This includes: o Evaluation of options for equivalence o Evaluation of options for State of the art o Suggestions for potential sources of clinical data and when a clinical investigation may be needed o Suggestions for sources and types of Post-Market Surveillance data o Suggestion for sources of non-Clinical data o General guidance. Clinical Evaluation Plan: Develop a Clinical Evaluation Plan for the Clinical Evaluation Report to outline the requirements for equivalency; state of the art; qualified evaluators; data sources to be used (e.g., literature search or clinical investigation); and post-market surveillance as recommended in MEDDEV 2.7/1 rev. 4 and EU MDR. Clinical Evaluation Report: Prepare a Clinical Evaluation Report to establish conformity to the essential requirements, a positive risk/benefit profile, post-market requirements, and frequency of updates. Clinical Literature Review – Safety and Performance: Safety & performance clinical literature review using multiple databases that includes a literature review protocol; identification, appraisal, and analysis of the literature to substantiate the clinical need, safety, and performance; and a report summarizing the findings. Clinical Literature Review – State of t he Art: State of the art clinical literature review using multiple databases that includes a literature review protocol; identifying, appraising, and analyzing current technology and medical treatment alternatives; and a report summarizing the findings. See back for specific CER experience... Regulatory and Quality Solutions LLC (R&Q) provides industry-leading regulatory and quality consulting and engineering services to medical device companies. RQTeam com C E R E X P R I E N C E R&Q has supported a broad range ofCER projects across many therapeutic areas and product types. C L A S S I ■ C L A S S I I a ■ C L A S S I I b ■ C L A S S I I I Therapeutic areas with CER projects: Cardiovascular- implantables, injection systems, syringes, catheters, LVADs, balloon pumps Respiratory-CPAPs, CPAP masks, respirators, tubing General hospital -wound care, infusion pumps Dental -orthodontics Orthopedic implantable-hips, spine, knees Obstetrical and gynecological -contraception aid Dermatology C O N S U L TA N T S W I T HC E R E X P E R I E N C E C E R s C O M P L E T E DI N P A S T T H R E E Y E A R S R&Q Supporti

FAQs

What does MEDDEV 2.7.1 Rev 4 change for CERs?

Rev 4 is more prescriptive and requires greater quantity and quality of information for clinical evaluations. It adds expectations for equivalence, the data used to establish equivalence, and increased requirements for evaluator expertise.

Which areas are listed as significant changes in MEDDEV 2.7/1 Rev 4?

The document highlights Clinical Evaluation Plan, frequency of CER updates, evaluator qualifications, equivalence, and state of the art as key change areas.

How can R&Q help manufacturers meet MEDDEV 2.7.1 Rev 4 requirements?

R&Q offers CER assessment and strategy development for the Clinical Evaluation Plan, supports preparation of the Clinical Evaluation Report, and performs clinical literature reviews for safety/performance and state of the art using multiple databases.

Sep 22, 2026

Upload by Jacob