01 Sep Clinical investigations with medical devices
The European Commission has just published the date for the entry into force of the new regulation on clinical trials for medicinal products, Regulation 536/20/EC; it will be 3 January 2022. This has given us an opportunity to discuss what standards and procedures apply to medical devices. Clinical investigations involving medical devices are regulated by MDR 2017/745. For in vitro diagnostic medical devices, the basis can be found in IVDR 2017/746.
What are the requirements for clinical investigations?
The MDR Regulation devotes its Chapter VI to Clinical Evaluation and Clinical Investigations. In particular, it lays down the general requirements that they must fulfil in order to be used for the demonstration of conformity. The IVDR Regulation also provides guidelines for conducting Performance Studies with in vitro diagnostic medical devices.
It broadly provides that clinical investigations involving medical devices and in vitromedical devices shall be subject to scientific and ethical review. This means that they must be approved by an ethics committee, and in the case of Spain, they must be authorised by the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios).
The documents to be submitted to the ethics committee are specified by the committee of the institution that will host the research. The research protocol, explaining the reasons for conducting the trial, benefits and inclusion/exclusion criteria, is the main document to be submitted.
Clinical research with medical devices in Spain
Among the documents to be submitted to the AEMPS are the User’s Manual, an Investigator’s Manual, a Clinical Investigation Plan, the patient information sheet and the informed consent form.
It should also be borne in mind that the medical device must have passed the applicable laboratory tests and trials, in this case all those necessary to ensure the safety of the research subjects must be carried out.
On the part of the AEMPS, new legislation is being developed that will establish requirements in relation to those aspects that the Regulations leave to the discretion of the national competent authorities. Until its publication, the national provisions contained in Royal Decree 1591/2009 of 16 October 2009 and Royal Decree 1616/2009 of 26 October 2009 shall continue to apply in so far as they do not conflict with Regulation 2017/745 of 5 April 2017. If, in addition, you want to comply with the code of good practice for clinical research involving human subjects, you should consult ISO 14155:2020.
At Episkey Medical Consulting we advise and prepare the necessary documentation to carry out clinical research with medical devices. Contact us and we will give you more information.