The MEDDEV 2.7/1 Rev 4 guidelines,

released in June 2016, provide

updated guidance on clinical

evaluation in Europe to the medical

device manufacturers and noti�ed

bodies under directives 93/42/EEC

and 90/385/EEC. The latest revision

(Rev 4) e�ectively replaces Rev 3

published in December 2009. While

the ideology of evaluating clinical

evidence to demonstrate compliance

with relevant Essential Requirements

remains unchanged, the Rev 4

guidelines detail the requirement for

clinical evaluation. This short

communication highlights the four

key changes in Rev 4 guidelines

pertaining to clinical evaluation and

provides Indegene’s perspective and

expertise on clinical evaluation

reports (CERs) meeting Rev 4

requirements.

KEY CHANGES IN MEDDEV 2.7/1 REV 4 GUIDELINESPerspectives in Addressing These Changes

INDEGENE PERSPECTIVE

info@indegene.com E W www.indegene.com +1 732 750 2901P +1 732 750 7990FIndegene, 485B Route 1 South, Suite 300, Iselin, NJ 08830.

State-of-the-Art

In the process of

identifying

state-of-the-art in the

corresponding medical

�eld, the Rev 4

mandates for a detailed

evaluation of current

treatment landscape,

safety, and performance

of subject device,

equivalent device, or

benchmark device, as

well as assessment of

bene�t-risk pro�les of

alternative therapies

available to the target

patient population.

Noti�ed bodies have already started expecting CERs in compliance with Rev 4 guidelines. Subject matter expertise

across therapy areas is essential to perform clinical evaluation in a robust manner and to address the key changes

discussed above. Further, collaboration is required among the clinical, quality, and regulatory divisions of medical

device companies to conduct extensive gap analysis comparing the Rev 3 and Rev 4 guidelines, and improvise the

format and layout of CER templates.

Post-Market Clinical Follow-up (PMCF)

The evaluators should

determine PMCF needs.

A PMCF study may be

required in case of

possible residual risks

and/or any unanswered

questions related to

long-term safety or

performance. A

justi�cation should be

provided if PMCF is not

planned as part of the

post-market surveillance

(PMS) plan.

Risk-Benefit Analysis

The Rev 4 elaborates on

the requirement for an

acceptable risk-bene�t

pro�le. Bene�ts and risks

associated with the

medical device should

be detailed from the

perspective of

magnitude, probability,

and duration. Risks

should be discussed

individually and

collectively for an overall

risk-bene�t evaluation.

Equivalence

The Rev 4 recommends

that equivalence can

only be based on a

single device. The

equivalent device

should be similar to the

subject device in terms

of clinical, technical, and

biological

characteristics.

Importantly, justi�cation

needs to be provided

explaining why the

di�erences between the

devices do not

signi�cantly a�ect the

clinical performance and

clinical safety of the

subject device.