MDCG 2024-4 – Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746
The MDCG has published a guidance document concerning safety reporting in performance studies of in vitro diagnostic medical devices under the IVDR. For some background, safety reporting in performance studies of IVD’s shall be performed in line with the requirements of Article 76(2) of the IVDR. According to Article 76(2) of the IVDR, the sponsor ...
Who Needs Quality Management Systems (QMS) under Regulation (EU) 2017/745 (MDR) and does it need to be ISO13485 Accredited?
The simple answer is all manufacturers must have a quality management system to comply with the MDR and in compliance with Article 10 (9). However, as with much of the MDR, if only it was that simple. In an excerpt of Article 10 (9) it states: ‘Manufacturers of devices, other than investigational devices, shall establish, ...
New MDCG Guidance Issued Concerning the Clinical Investigation Plan for Clinical Investigations of Medical Devices.
The MDCG have published a guidance document on preparing the clinical investigation plan, in accordance with Section 3 of Chapter II of Annex XV of the MDR as well as the international standard ISO 14155:2020. The former is the legally required content of the Clinical Investigation Plan while the latter addresses good clinical practice for ...
Labelling Under the MDR
A label provides a wealth of information regarding your medical device that is communicated to the end user or patient. Therefore, it is of utmost importance that you have all the relevant information on the label as laid out in Annex I Section 23 of the MDR. Annex I 23.1 (h) states that; Where appropriate, ...
MDCG 2024-2: Procedures for the updates of the European Medical Device Nomenclature
The MDCG has released a guidance document concerning EMDN codes. This document is split into three main sections and provides an overview of the actors involved in the generation and maintenance of the EMDN codes and lays out the procedures for the annual revision of the EMDN Codes as well as the procedure for ad-hoc ...
MDCG 2023-7 Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence.
The MDCG has released a guidance document regarding exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR. This guidance is intended to clarify the exemptions from the requirement to perform clinical investigations, and associated conditions related to the demonstration of equivalence, for implantable and class III medical devices to be placed ...
MDCG 2019-07 Rev.1 Guidance on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)
The MDCG has updated a guidance document, initially published in 2019 regarding article 15 of the MDR and IVDR concerning the Person Responsible for Regulatory Compliance, commonly abbreviated to PRRC. Among the plethora of updates that have been introduced in the guidance document, most notably, the new updated guidance document sees the following updates: The ...
MDCG 2021-27 Rev.1 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
The MDCG has updated a guidance document initially released in 2021 regarding Article 13 and 14 of the MDR and IVDR concerning the obligations of importers and distributers. The updates that have been published in this revision include the addition of a number of questions. These include: The updated guidance document can be accessed using ...
MDCG 2023-6: Guidance on demonstration of equivalence for Annex XVI products
The MDCG has released a guidance document relating to the equivalence for Annex XVI products, commonly referred to as Devices Without a Medical Intended Purpose. This is the second guidance document that has been released this month concerning Annex XVI devices. To offer some background to this guidance document, the MDR provides a possibility to ...
MDCG 2023-5: Guidance on qualification and classification of Annex XVI products.
The MDCG has released a guidance entitled MDCG 2023-5: Guidance on qualification and classification of Annex XVI products. This guidance is one of two new guidance’s issued by the MDCG regarding Annex XVI products during the month of December. This guidance document provides elements useful for the qualification of a product as a product without ...
