Clinical evaluation for medical devices under the EU MDR

Clinical evaluation for medical devices is the documented process of collecting and appraising clinical data to show that a device is safe, performs as intended and has an acceptable benefit risk profile, and under the EU Medical Device Regulation (MDR) every device needs one, whatever its class. The legal basis is Article 61 and Annex XIV. The output is the clinical evaluation report (CER), and post market clinical follow up (PMCF) keeps it current for the life of the device. Below we set out what Article 61 requires, what goes into a CER, how equivalence works under MDCG 2020-5 and the contract rule for Class III and implantable devices, when a clinical investigation is needed, where MEDDEV 2.7/1 revision 4 stands, and how the evaluation links to investigations run to ISO 14155.

What does Article 61 of the MDR require?

Article 61(1) sets the rule. Confirmation of conformity with the relevant general safety and performance requirements (GSPRs) “shall be based on clinical data providing sufficient clinical evidence”. It applies to every class. The belief that a Class I device does not need a clinical evaluation is wrong, and it is one of the misconceptions we correct most often. The evaluation for a low risk device can be short. It cannot be absent.

Article 61(3) requires a defined and methodologically sound procedure, built on a critical evaluation of the relevant literature, a critical evaluation of the results of all available clinical investigations, and consideration of alternative treatment options.

Article 61(10) is the narrow exception. Where demonstrating conformity on clinical data is not deemed appropriate, the manufacturer must duly substantiate why non clinical methods alone are enough. That substantiation has to come from the risk management output. “We did not think clinical data were needed” is not a justification.

What is a clinical evaluation report under MDR?

Annex XIV Part A sets out the process, and the CER is where it ends up. The steps are:

1. A clinical evaluation plan, defining what the evaluation has to show and how it will show it.
2. A systematic literature review. In practice that means a documented search protocol that a reviewer could rerun and get the same results.
3. Appraisal of each data set the review and your own records produce.
4. Generation of new data where the appraisal shows gaps the existing evidence cannot fill.
5. The CER itself, bringing the analysis together and stating a conclusion on safety, performance and benefit risk.

Where CERs fail is rarely the conclusion. It is the trail. A literature search with no protocol, appraisal criteria that were never written down, or a conclusion that reads more confidently than the data behind it. Notified bodies read the method before they read the answer, which is why the CER is one of the documents covered in our guide to what notified bodies check in a technical file.

How do you demonstrate equivalence under MDR?

Equivalence lets you use clinical data from another device as evidence for yours. Under Annex XIV the two devices must be similar in their technical, biological and clinical characteristics, “similar to the extent that there would be no clinically significant difference” in safety and clinical performance. You also need “sufficient levels of access” to the data on the other device.

MDCG 2020-5, from April 2020, is the equivalence guidance, and MDCG 2023-7, from December 2023, covers what sufficient levels of access means in practice.

For Class III and implantable devices, Article 61(5) goes further. Claiming equivalence to another manufacturer’s device requires “a contract in place that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis”. The access has to continue. A one time data pack does not meet the rule.

This is where many equivalence strategies fail. Plenty of manufacturers came into the MDR expecting to rely on equivalence to a competitor’s device, as they had under the Directives. Under the MDR, for Class III and implantables, it only works if the competitor signs a contract giving you continuing access to its technical documentation. In our experience very few will. If your clinical strategy for a high risk device rests on equivalence to someone else’s product, test that assumption first, before any other part of the plan is built on it.

Do you need a clinical investigation?

Article 61(4) requires clinical investigations for implantable and Class III devices, unless an exemption applies. One exemption rests on equivalence, with the notified body agreeing. There are others, and MDCG 2023-7 covers them. Article 61(6) adds further exemptions, under conditions, for certain legacy devices with sufficient clinical data and for listed items: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.

“Do I need a clinical investigation for a Class IIb device?” is one of the questions we are asked most. If the Class IIb device is not implantable, Article 61(4) does not make an investigation mandatory. The device still needs sufficient clinical evidence under Article 61(1). If literature and existing data cannot provide it, you generate new data, and that may mean an investigation anyway. An implantable Class IIb device falls within Article 61(4). Check the class first, with our medical device classification guide if you are not certain of it.

Where an investigation is needed, it is run to ISO 14155. ISO 14155:2026 is the current ISO edition. Check which edition is cited as the harmonised standard before you reference it in your documentation, because the ISO edition and the harmonised European reference do not always move together. Our guide to ISO 14155 and when a clinical investigation is required covers the standard in detail.

What is PMCF and when is it required?

Annex XIV Part B describes PMCF as “a continuous process that updates the clinical evaluation”. You write a PMCF plan, run it, and write a PMCF evaluation report, and the findings feed back into the CER and into risk management.

PMCF is not optional. The post market surveillance plan must contain either a PMCF plan or a justification of why PMCF does not apply to the device. A justification is allowed, but it has to be one, reasoned from the device and its clinical data. A single line saying “not applicable” is not a justification. MDCG 2020-7 and MDCG 2020-8 provide the templates for the PMCF plan and the PMCF evaluation report. The wider surveillance system PMCF sits inside is covered in our guide to post market surveillance for medical devices.

Implantable and Class III devices, other than custom made and investigational devices, also need a summary of safety and clinical performance (SSCP) under Article 32. Article 83 requires post market surveillance data to be used to update it, so it moves with the CER rather than being written once.

Is MEDDEV 2.7/1 rev 4 still valid under MDR?

MEDDEV 2.7/1 revision 4 is European Commission guidance written for the old Directives, 93/42/EEC and 90/385/EEC. It is not an MDR guidance document. Article 61 and Annex XIV are the law under the MDR, and the MDCG documents are the guidance that interprets them.

That does not mean every CER built on MEDDEV is worthless. MDCG 2020-6 addresses how MEDDEV relates to clinical evaluation under the MDR, and it is the document to read before relying on any part of MEDDEV in a current file. What does not work is a CER that cites MEDDEV as its governing standard and never mentions Article 61. We see that most often in legacy devices moving from the Medical Devices Directive (MDD) to the MDR, where the CER was last rewritten under the Directive.

Guidance	Date	What it covers
MDCG 2020-5	April 2020	Equivalence
MDCG 2020-6	April 2020	Sufficient clinical evidence for legacy devices, and how MEDDEV 2.7/1 rev 4 relates to the MDR
MDCG 2020-7	April 2020	PMCF plan template
MDCG 2020-8	April 2020	PMCF evaluation report template
MDCG 2020-13	July 2020	Clinical evaluation assessment report (CEAR) template
MDCG 2023-7	December 2023	Exemptions from clinical investigations under Article 61(4) to (6), and sufficient levels of access for equivalence
MDCG 2024-10	June 2024	Orphan devices

Where Worldwide Device Solutions fits

We write and remediate clinical evaluations that survive notified body review: plans, literature protocols, CERs, PMCF plans and the justifications that hold when a reviewer pushes on them. That comes from 500+ CE technical files built and approved and 250+ Notified Body audits delivered. If your CER was written under MEDDEV, or your clinical strategy leans on equivalence, find out now rather than at the next audit.

Our transition service for the MDR and the in vitro diagnostic regulation (IVDR) covers clinical evidence remediation as part of moving devices onto the MDR. Book a free consultation, or start with the fixed fee Gap Assessment, which puts your clinical evidence against Article 61 and Annex XIV and tells you what is missing.