Carrying Out A Clinical Investigation Under MDR
As part of our ongoing MDR series, we are looking at clinical investigations and how they will operate after the MDR has been introduced. We have written extensively on the MDR issues and at the end of this article, you can access our range of whitepapers and other articles that look at the changes that the new regulations will bring about.
The Requirement of a Clinical InvestigationMDR Articles 62-82 and Annex XV cover the requirements of Clinical Investigations.
Clinical investigations form part of the overall Clinical Evaluation of a device and are required for certain devices classes.
Class III devices and Implantable devices require a Clinical Investigation – (with exceptions are per Article 61 (4) and (6) )
Clinical Literature Evaluation is required for all classes of devices under MDR, however, proving equivalence to another device is now much harder to establish under MDR and therefore, clinical evaluation of the literature as the sole source of clinical evidence is much harder to establish and so a Clinical Investigation may also be needed for Class IIa and IIb devices.
The current MEDDEVs relevant to this area are:
- 2.7/4 Guidelines on Clinical Investigations – A guide for manufacturers and Notified bodies
- 2.7/2 Guidelines for Competent Authorities– for making a Validation/Assessment of a Clinical Investigation Application
- 2.7/3 Guidelines for Medical Devices – Clinical Investigations; Serious Adverse Event Reporting
These are used in conjunction with the MDD 93/42/EEC but have very similar Clinical Investigation requirements to the requirements of the MDR with some additional requirements including:
Introduction of a Sponsor:
Article 2 (49) Sponsor means ‘any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation’. Under MDR this means that investigators initiating clinical studies will be responsible for meeting MDR clinical study requirements.
- Article 62 Legal representative must be appointed, who is responsible for ensuring compliance with sponsors obligations
- Annex XV New restrictions regarding appointment of a monitor who is independent of Investigational site
- Article 80 – inclusion of requirement for sponsor to report to all Member states in which clinical investigation is conducted, without delay ‘any serious adverse event that has a causal relationship with the investigational device, the comparator or the investigation procedure or where such causal relationship is reasonably possible’
- Annex XV –policy regarding follow up and management of any deviations from the Clinical Investigational Plan at the investigational site and clear prohibition of the use of waivers from the Clinical Investigational plan
It should be noted that ISO 14155:2011 (Clinical Investigation of Medical Devices for Human subjects – Good Clinical Practice’ aligns closely with the new MDR.
This standard contains detailed information about the procedure and content of a clinical investigation plan.
Clinical Master Plan
If a clinical investigation is required under MDR, the type, structure, and parameters of it must be defined within the overall Clinical Master Plan.
The clinical study structure must be based on the objective (e.g., demonstrate the performance); the need to demonstrate equivalence through prospective human clinical investigation (this can be with literature as the control); and finally, the risk and “innovative level.”
Manufacturers must consider the definition of Clinical Evidence in Article 2 (51) in their selection of the study structure that will provide useful results:
clinical evidence’ means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s) when used as intended by the manufacturer;
Using A Clinical Research Organisation
The use of a Clinical Research organisation (CRO) is recommended for data quality purposes. If a post-market clinical follow-up study (PMCF) is required, the analysis, trending updating of reports may necessitate a manufacturer to obtain outside assistance for this work. The purpose of the PMCF is to verify the safety and performance profile that the study sponsor acquired through the selected group of users and patients in the pre-CE-Marking study.
In conclusion, it is important that manufacturers should decide as early as possible whether to conduct a Clinical Investigation. The decision should be based on reasonable scientific and defend-able grounds and in full consideration of the requirements under MDR, with additional support and expert input if necessary.
We Can Help
Acorn Regulatory has a large expert team that works with clients on all aspects of clinical matters relating to the new medical device regulations. We can help your company with any issues that you might have. Contact us today on 00353 52 61 76706 or email us: email@example.com or complete the form below and we will get back in touch with you.
Further MDR Reading from Acorn Regulatory
The 5 Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under MDR
As part of our series of articles looking at some of the changes on the way for medical device regulation under MDR, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC).
The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices. Read more here.
Get The Acorn Regulatory Medical Device Regulations Whitepaper
The new medical device regulations (MDR) will come into force in May 2020. In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations. For many companies, there is still much work to do. Also, companies are still actively seeking further information about the regulations and how they will be applied. Read the first whitepaper here
2nd Acorn Regulatory MDR Whitepaper: Be Prepared for May 2020
Our second Acorn Regulatory MDR whitepaper looks at the issues of unique device identifiers, the role of Eudamed under MDR and post-market surveillance. Read the second MDR whitepaper here.
The Medical Device Regulations – MDR – What You Need To Know
The introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we work with medical devices. Our medical device team has been working with many companies to support them for the changeover from the MDD to MDR. During the course of our interactions with these clients, there are many topics that are being raised time and again. Read more here.