Clinical Investigation Ecosystem
A clinical investigation is a clinical trial (study) in at least one human subject, which is undertaken to assess the performance, and most importantly, the safety of a specific medical device. MDR Article 2(45) defines ‘clinical investigation’ as any systematic investigation involving one or more human subjects to assess a device’s safety or performance. When clinical investigations are conducted under MDR, they will also need to comply with any applicable common specifications defined in Article 2(71) in addition to requirements in Articles 62-80.
Regulators have widened their scope and as per EU MDR 2017.745, Article 61(4), clinical investigations are now required for approvals of implantable devices and class III medical devices.
Are there any exceptions for Class III Medical Devices?
Well, yes, the following categories are exempted from a clinical evaluation:
The device has been designed by modifications of a device already marketed by the same manufacturer,
The manufacturer has demonstrated the modified device to be equivalent to the marketed device, in accordance with Section 3 of Annex XIV, and the notified body has endorsed this demonstration, and
The clinical evaluation of the marketed device is sufficient to demonstrate the conformity of the modified device with the relevant safety and performance requirements.
In these cases, the notified bodies shall check the details on a PMCF plan, including post-market studies. This is important as the documents will demonstrate or confirm the safety and performance of the device.
The clinical investigation process begins with a clinical investigation plan and involves various players from the ecosystem.
A medical device requires a mammoth of planning activity, and a Clinical Investigation Plan (CIP) is one of the activities.
The Clinical Investigation Plan involves
- Patient Population information
- Well defined and Measurable Objectives
- Ethical Consideration and informed Consent
- Criteria for stopping the trial
As a manufacturer, you must pay close attention to your roles and responsibilities. Suppose you are a non-EU manufacturer conducting trials in Europe? In this scenario, you must have a sponsor and a legal or natural person who is Union-established acting as a legal representative. The sponsor or manufacturer is responsible for
- Design of the study
- Principal Investigator designation
- Application with the ethical committee
- Maintain all legal documents
- Incident and vigilance reporting
Next is the role of the Competent Authority. Upon completion of clinical investigation registration, competent authorities are saddled with the responsibility of providing the authorization for a clinical investigation to begin. According to the MDR, approval could take less than a month. The Commission may engage in delegated acts to fine-tune the procedure. Each clinical investigation receives one single registration number or SRN. This is to maintain a more efficient and reliable exchange of data between member states, the Commission, the public, and others.
Last in line is the Notified Body. They will review the clinical evaluation and, if required, the clinical investigation. These documents and others are part of the technical documentation review before granting a CE certificate. There are many processes, reports, and personnel that undergo inspection or scrutiny before approval which includes, in part:
- A benefit-to-risk analysis
- An inspection or discussion of how the device fits into current clinical practice by evaluating the state-of-the-art information
- Assessing safety and performance data concerning all indications and label claims
- An assessment of clinical safety and performance
- Auditing the manufacturer and its personnel
- Evaluation of post-marketing or post-approval processes and plans
The EU MDR is an intriguing story about redemption within the medical device sector or business. It’s about having a final chance to make a change before it’s too late. If done correctly, clinical evaluations, along with clinical investigations, are steps being taken now to ensure a bright, safe, and innovative future for medical device development that meets real and meaningful unmet medical needs.
Understanding the requirements around clinical evaluations and investigations can prevent panic and apprehension associated with medical device approvals. If you have further questions, don’t hesitate to contact our experts, and let’s talk.
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