The Medical Device Coordination Group (MDCG) has recently published some useful guidance on Medical Devices to provide information and support to stakeholders in the application of the MDR (EU) 2017/745 and IVDR (EU) 2017/746 Regulations.
Please find below a summary of the main topic of each document.
MDCG guidance documents published in April 2021
- MDCG 2021-4 “Application of transitional provisions for certification of class D in vitro diagnostic Medical Devices according to Regulation (EU) 2017/746” presents a series of questions and answers to provide information on the steps to follow for the certification of class D In-Vitro Diagnostic Medical Devices.
- MDCG 2021-5 “Guidance on standardisation for Medical Devices” is a useful document for Manufacturers because it provides guidance on the use of harmonized standards to demonstrate compliance with the MDR (EU) 2017/745 and IVDR (EU) 2017/746 Regulations.
- MDCG 2021-6 “Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation” shows a series of questions and answers regarding clinical investigations of Medical Devices. This document is addressed to the stakeholders that intend to undertake clinical investigations within the scope of the MDR (EU) 2017/745 Regulation.
An important aspect pointed out in this document is the difference between:
- Performance, which is considered as the ability of a medical device to achieve its intended purpose;
- Clinical performance, which is considered as the ability of a device to achieve its intended purpose, leading to a clinical benefit for the patient;
- Clinical benefit which is intended as the positive impact of a device on the health of a patient, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome.
Revision of MDCG 2021-1 guidance published in May 2021
In early May the MDCG published an update of the MDCG 2021-1 REV.1 guidance “Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional”. This document focuses on the MDR (UE) 2017/745 requirements, including those referred to in Article 123 (paragraph 3, point d and e) and the alternative technical solutions to be taken into account for the exchange of information until EUDAMED is fully functional.
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