Questions & Answers – MDCG 2021-6 / Regulation (EU) 2017/745 (Part 1)

July 20, 2022
Questions & Answers – MDCG 2021-6 / Regulation (EU) 2017/745 (Part 1)
  1. What are the general differences and improvements related to clinical investigations under the new Regulation (EU) 2017/745 (MDR) as compared to the Directives 93/42/EEC and 90/385/EEC?
  • Regulation (EU) 2017/745 (MDR) will progressively replace both Directives (93/42/EEC and 90/385/EEC) and their transpositions in national law.
  • The first difference is regarding the type of the law. A Directive is a legislative act that sets out a goal that all EU countries must achieve. However, it is up to the individual countries how to reach these goals by the implementation of national laws.
  •  A Regulation, as opposed to a Directive, is a binding legislative act that must be applied in its entirety across the EU on the date of application. It means that the rules are applied in an identical manner throughout the EU.
  • Member States, in authorizing and supervising the conduct of a clinical investigation, will be required to base their assessments and decisions on the same rules.
  • The MDR contains greater detail than the Directive, which is a result of implementing aspects related to good clinical practice, many of which have previously been present in the form of guidance and standard documents.
  • Further harmonization at European level will provide greater certainty, which will support an environment that provides greater predictability and is more favorable for conducting clinical investigations, with the highest standards of patient safety, for all EU Member States.
  • It will not only harmonize decisions, but also foster work sharing and collaboration between Member States and enhance the transparency regarding these studies.
  • For certain clinical investigations, the sponsor still needs to check and follow any specific national provisions which may apply.
  1. What is a clinical investigation?
  • A clinical investigation is defined by the MDR as any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.
  1. What is the difference between the performance, clinical performance and clinical benefit?
  • In accordance with the MDR, the performance of a device is its ability to achieve its intended purpose as stated by the manufacturer.
  • By extension, the clinical performance of a medical device is the ability of the device to achieve its intended purpose, thereby leading to a clinical benefit when used as intended.
  • Clinical benefit means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health.
  1. Which regulatory pathway shall a sponsor follow in order to conduct a clinical investigation to collect clinical data that will be used to support the conformity assessment procedure of the investigated medical device?
  • Article 62(1) of the MDR foresees that the clinical investigations carried out, as part of the clinical evaluation for conformity assessment purposes, shall be designed, authorized, conducted, recorded and reported in accordance with the provisions of Articles 62 to 80 of the MDR.
  • There are one or more purposes of clinical investigations; e.g. to establish and verify performance, clinical benefits, clinical safety and any undesirable side-effects.
  • For clinical investigations of class I, or non-invasive class IIa or class IIb devices, it is necessary to check national provisions.

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