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The European Commission (EC) published its second annual overview concerning medical devices subject to the Clinical Evaluation Consultation Procedure (CECP) (Article 54) of the Medical Devices Regulation (MDR) (EU) 2017/745. This is an update to the first CECP report (April 2021-June 2022). The current report summarizes activities of expert panels to the CECP from July 2022 through June 2023. C..

What is an investigator’s brochure? The investigator’s brochure (IB) is referenced in the European Medical Devices Regulation (2017/745, MDR). However, those unfamiliar with the term IB will find it defined in Annex XV, Chapter II, Section 2. In the interest of completeness, there is a catch-all expectation in MDR Article 62 on clinical investigations. MDR Article 62(4)(m) states “the requiremen..

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies. The SSP shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (Eudamed). Text elements in italic i..

Introduction When a sponsor of a clinical investigation shall submit an application according to article 70(1) of the MDR, the application shall be accompanied by the documentation referred to in Chapter II of Annex XV of the MDR. The Investigator’s Brochure (IB) is part of the required documentation and is one of the means by which the sponsor is to fulfil the requirement in section 2.7 of Chap..

The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - through the European Health and Digital Executive Agency (HaDEA) - commissioned a “Stud on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market". The study started in December 2022 and was performed over 14 months. It was contracted to a consortium led by the Austrian..

March in Europe The European Commission (EC) updated several medical device safety regulation documents in March 2024. This includes additional standards harmonized with the Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostics Devices Regulation (2017/746, IVDR) and published in the Official Journal of European Union (OJEU). It also includes an updated study on Notified Body appli..

Description The Commission and Member States have created MDR and IVDR tables. These tables aim to help manufacturers of medical devices and in vitro diagnostic medical devices, particularly small and medium-sized ones, understand the language requirements for the information and instructions that accompany a device in a specific country. The tables provide an overview of the language requiremen..

When a sponsor of a clinical investigation submits an application according to article 70(1) of the MDR, to the Member State(s) in which the clinical investigation is to be conducted, the application shall be accompanied by the documentation referred to in Chapter II of Annex XV of the MDR. According to section 2 of Chapter I of Annex XV of the MDR, clinical investigations shall be performed on ..

Background - EURL designation 2023 In July 2022, the European Commission launched a call for the designation of EU reference laboratories in 8 categories of class D devices. Applicant laboratories had six months to prepare and submit applications to their Member State. The Commission reviewed the applications based on the following elements specified in the call: the applicant laboratories must ..

Emergo에서 아래와 같이 웨비나를 개최한다. ​ ▶ 주제: In-house tests under EU IVDR - How to best meet your IVDR deadlines ▶ 일시: 2024년 02월 28일 CST 9시 (한국시간: 03월 13일 23시) The presenter will provide more details on how to be best prepared for an external audit (FDA, MDSAP, ISO, etc.), as well as a practical approach to what to do before the audit and common pitfalls based on industry experience. We will also highligh..