MDR Clinical Investigations

Clinical investigations are conducted to verify the intended purpose, clinical benefits, performance and safety of the device.

MDR Definitions:

clinical investigation’ means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device;

‘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;

investigator’ means an individual responsible for the conduct of a clinical investigation at a clinical investigation site;

legal representative: Article 62(2) Where the sponsor of a clinical investigation is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation and shall be the addressee for all communications with the sponsor provided for in this Regulation. Any communication with that legal representative shall be deemed to be a communication with the sponsor.

Clinical investigations requirements are defined in article 62 to 80 and Annex XV.

Article 72(5): Member States shall inspect investigation site(s) to check that clinical investigations are conducted in accordance with the requirements of the MDR and the clinical investigation plan (CIP).

·       Article 62 General requirements regarding clinical investigations conducted to demonstrate conformity of devices

·       Article 63 Informed consent

·       Article 64 Clinical investigations on incapacitated subjects

·       Article 65 Clinical investigations on minors

·       Article 66 Clinical investigations on pregnant or breastfeeding women

·       Article 67 Additional national measures

·       Article 68 Clinical investigations in emergency situations

·       Article 69 Damage compensation

·       Article 70 Application for clinical investigations

·       Article 71 Assessment by Member States

·       Article 72 Conduct of a clinical investigation

·       Article 73 Electronic system on clinical investigations

·       Article 74 Clinical investigations regarding devices bearing the CE marking

·       Article 75 Substantial modifications to clinical investigations

·       Article 76 Corrective measures to be taken by Member States and information exchange between Member States

·       Article 77 Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination

·       Article 78 Coordinated assessment procedure for clinical investigations

o   Process for submitting a clinical investigation application where the investigation is planned to be conducted in more than one Member State.

·       Article 79 Review of coordinated assessment procedure

·       Article 80 Recording and reporting of adverse events that occur during clinical investigations

 Application submission process given below,

ANNEX XV Chapter I General requirements of clinical investigations

·       Clinical investigations shall be carried out in accordance with recognised ethical principles.

·       it shall be performed in accordance with the clinical investigation plan.

·       All the technical and functional features of the device including safety and performance, and their expected clinical outcomes shall be appropriately addressed in the investigational design.

·       It shall in line with the clinical evaluation plan as referred to in Part A of Annex XIV

ANNEX XV CHAPTER II Documentation regarding the application for clinical investigation

Sponsor shall submit the following documents to conduct a clinical investigation

Documents required for clinical investigations:

1.       Application form

2.       Investigator's Brochure (IB): Summary of clinical and non-clinical information

3.       Clinical Investigation Plan:

·       Rationale

·       Objectives

·       Design methodology

·       Monitoring, conduct, record-keeping

·       Method of analysis for the clinical investigation

Content of application form is given below:

 

Sponsor obligations

Article 80 Report adverse events and device deficiencies that occur during clinical investigations to the Member States in which those clinical investigations are being conducted.

Article 72(6): Establish a procedure for emergency situations which enables the immediate identification and, where necessary, an immediate recall of the devices used in the clinical investigation

Article 77: Update the end of a clinical investigation or in the event of a temporary halt or early termination through electronic system.

ANNEX XV Chapter I: Arrange and verify the training to the personnel involved in the conduct of an investigation.

ANNEX XV Chapter I: Other sponsor obligations

1.Prepare and keep the documentation per annex XV Chapter II. Keep the documentation for 10 years after the clinical investigation completed or device placed on the market. Time period for implantable devices are at least 15 years.

2.Ensure proper monitoring.

·       appoint a monitor that is independent from the investigational site

3.Shall complete the follow-up of investigation subjects

4.Conduct internal or external inspection to check the investigation is being conducted in line with good clinical practice

5.Prepare a clinical investigation report

Click below link to know more about IVDR Clinical Performance Study :https://meddev-info.blogspot.com/2021/04/ivdr-clinical-performance-study.html

 Source: 

1.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

2.BSI whitepaper on Medical device clinical investigations – What’s new under the MDR?