Clinical Evaluation EU-MDR requirements
This article provides a brief overview of Clinical Evaluation requirements as described in the European Medical Device Regulation – EU MDR [Regulation (EU) 2017/745].
What is meant by the term ‘clinical evaluation’ in the EU MDR?
The EU Medical Device Regulation (EU MDR) defines clinical evaluation as “a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits of the device when used as intended by the manufacturer.”
(EU MDR Annex 2 (44)).
EU-MDR requirements for clinical evaluation of medical devices
The clinical evaluation of a medical device (product) should:
- Follow a defined, methodologically sound procedure
- Include a thoroughly documented critical evaluation of the results of all clinical investigations, including but not limited to:
- A scientific evaluation of all information & results from product development testing, clinical investigations, and any other product assessments/risk assessments performed by the manufacturer or other parties on its behalf
- All findings related to the product’s safety, quality, performance, etc.
- Be documented in a clinical evaluation assessment report
- Be based on currently available relevant scientific literature, such as:
- Clinical investigation findings and clinical evaluations relating to equivalent products or product types
- Industry standards, state of the art comparisons, etc.
- Identify gaps in clinical evidence through regular reviews of the relevant scientific literature
FAQs: Clinical Evaluation requirements & the EU Medical Device Regulation (EUMDR)
When is clinical evaluation required?
- Clinical evaluation must be conducted throughout the life cycle of a medical device, i.e. is required as an on-going process
- Clinical evaluation is also mandatory for initial CE marking and must be actively updated thereafter
What is the meaning of ‘CE’ (CE Mark or CE Marking) in the EU MDR?
A CE marking on a product in the EU is an indication that the product has been assessed by the manufacturer, and is deemed to meet EU safety, health, and environmental protection requirements.
The CE marking is required for products manufactured anywhere in the world, that are then being marketed to consumers in the European Union; and the requirement for the CE marking applies across all states
The regulatory requirements for CE marks on products in the EU is referred to as the ‘CE Mark Directives & Regulations’. Source: EU Trade Publications et al.
How is a CE mark/CE marking attained?
To attain a CE, the manufacturer must create a technical file detailing how the product meets the applicable directives and regulations, such as through product design, product testing, and risk assessments across the lifecycle of the product, including during earliest stages of development.
- The manufacturer must then perform (or arrange) a conformity assessment as appropriate (for example, by a Notified Body). The conformity assessment is essentially a verification that the product meets the required directives and regulations relevant to its particular product type/risk classification.
What is a conformity assessment?
“Conformity assessment procedures provide a means of ensuring that the products, services, systems, persons, or bodies have certain required characteristics, and that these characteristics are consistent from product to product, service to service, system to system, etc. Conformity assessment can include:
- Supplier’s declaration of conformity
- Sampling and testing
- Management system assessment
- The accreditation of the competence of those activities
- Recognition of an accreditation program’s capability.”
Source: National Institute of Standards and Technology (NIST)
How are the terms ‘clinical evaluation’ and ‘conformity’ or ‘conformity assessment’ related?
In brief, a clinical evaluation is an assessment and verification of the product’s conformity to global standards, EU directives and other regulatory requirements.
Definition of clinical evaluation:
“[A clinical evaluation is] confirmation of conformity with relevant general safety and performance requirements (GSPRs) set out in Annex I under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk-ratio based on clinical data providing sufficient clinical evidence”
(Article 61: Clinical Evaluation).
Essential elements of Clinical evaluation activities and documentation
- Clinical evaluations should follow a defined and methodologically sound procedure, based on relevant scientific literature, currently available.
- A critical evaluation of the results of all clinical investigations should be performed by appropriately qualified and skilled personnel.
- It generally includes scientific literature on equivalent products as well as any clinical investigation(s) performed to assess the benefits-to-risk ratios and other characteristics of the product including required characteristics/specifications, safety, and performance.
Documentation requirements for the Clinical Evaluation submissions:
The following documents should be available:
- A Clinical Evaluation Plan (CEP)
- Clinical Development Plan (CDP)
- Clinical Evaluation Report (CER)
- Post Market Surveillance (PMS) Plan
- Post-Market Clinical Follow Up (PMCF) Plan
- Post-Market Clinical Follow Up (PMCF) Evaluation Report
- Post Market Surveillance (PMS) Report
- Periodic Safety Update Report (PSUR)
- Summary of Safety and Clinical Performance (SSCP
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Clinical evaluations: key terms and definitions
Clinical Evaluation Plan (CEP)
- Defines the scope and approach of a clinical evaluation
- Provides detailed information about the product/medical device, including:
- Intended purpose (intended use of the product)
- Intended patient groups (target groups)
- Indications for use and any contraindications
- Detailed descriptions of intended clinical benefits and clinical outcome parameters
Clinical Evaluation Report (CER)
The clinical evaluation report (CER) is a mandatory document for medical devices that are to be placed in the EU market.
- The CER is submitted along with the technical file
- If compliant, the device is awarded a ‘CE Mark’ which certifies that the device can safely be marketed/sold in the EU. Information to be included in the CER is listed in the table below
|Overview of the medical device|
|Clinical data on the device under evaluation|
|Post-market surveillance (PMS) data|
|Clinical data generated and held by the manufacturer|
Post Market Surveillance (PMS) Plan
The PMS plan defines how the device will be monitored after the market launch and what data is to be collected:
- The methodologies for analysing the data and the criteria for the analysis should be defined and state of the art
- Post Market Clinical Follow Up (PMCF) is part of PMS and intended to close the gaps that could not be answered in the scope of the clinical evaluation (e.g. monitoring of side effects and contra indications)
Post Market Surveillance (PMS) Report
A PMS Report is created for class I devices and includes a summary of the results from market data collected over the observation period and the outcomes are passed on to clinical evaluation.
- CAPA’s are documented and used for further product development as well as for ensuring the device’s safety and compliance with the requirements of the regulation at all times during the product lifecycle
- A Periodic Safety Update Report (PSUR) is prepared for class IIa, IIb, and III products and includes a summary of the results and CAPA as the PMS report
- In addition, the PSUR also includes the conclusions from the benefit-risk assessment and any critical results from PMCF
Clinical Evaluation Checklist for manufacturers
- Instruction for use
- Intended purpose
- Medical indication
- Intended target population
- Intended use
- Intended user
- Intended clinical benefits
- Possible complications and warnings
- Shelf life and storage
- PMS report (sales volumes and complaints)
- Biological evaluation report (biocompatibility assessment)
- Risk management files
- Design changes
- CE History and declaration of conformity
- Marketing brochure
- Identification of similar benchmark devices
- PMCF report
Risk management and Clinical Evaluations
Risk management principles and clinical evaluation activities conducted for a medical device are interconnected practices.
- These two processes are required to be updated regularly.
- Clinical evaluation, which is “an assessment and analysis of clinical data referring to a medical device throughout the life cycle of that medical device”, verifies the clinical safety and performance of the device when used as intended
- The result of this evaluation will be used as input for ongoing risk analysis to identify hazards and estimate identified risks
Manufacturers are encouraged to read the requirements set out in Article 61 Clinical evaluation, Annex I General Safety and Performance requirements and Annex XIV Clinical Evaluation and Post-Market Clinical Follow Up: Part A: Clinical Evaluation for further information.
Need support with finalising your QMS or to meet Medical Device regulatory requirements?
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ISO13485 – QMS for Medical Devices training
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Thank you for reading.
References and Further Reading:
MDR Guidance Resources and Download Links for the EU MDR
GMP compliance education and online training courses including EU MDR compliance training (release date: October 2022) as well as courses for ISO 13485 compliance, ISO 14971 compliance, and more, available at https://www.onlinegmptraining.com/gmp-training/store/
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, EU MDR.
EU MDR download link
Full title of EU MDR: “REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance)” – the EU MDR has been fully effective as of May 26, 2021.
Journal articles on the History of the EU MDR
The EU MDR went into application on May 26, 2021; and this regulatory publication details requirements of medical device manufacturers, including for clinical evidence and post-marketing surveillance.
Resources including the EU MDR (PDF) download link
Scope of the EU MDR – online format
Consolidated text of EU MDR (online version of EU MDR) including EU MDR scope and purpose, medical device manufacturer requirements, searchable MDR clauses, etc.
IMDRF resources: Clinical Evidence requirements for Medical Devices/Medical Device Manufacturers
IMDRF Clinical Evidence publications: International Medical Device Regulators Forum Title: Clinical Evidence – Key Definitions and Concepts Authoring Group: Medical Device Clinical Evaluation Working Group Date: 10 October 2019 (Final Document)
EU MDR terms and definitions – various resources
EU Legislation and CE Marking
National Institute of Standards and Technology (NIST Standards.gov) – Conformity Assessment Basics