MDCG Release Preliminary (re-)assessment review form templates for MDR and IVDR
The MDCG have released form templates relating to preliminary (re-)assessment of notified bodies. These templates are the following: The forms are relevant to assessing if the notified bodies meet the requirements to continue operating. There are different forms, concerning the different legislations, MDR and IVDR, and also forms depending on whether it is the first ...
UPDATE: MDCG 2022-4 Rev 2 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD
There has been an update to the guidance document MDCG 2022-4 regarding the appropriate surveillance for legacy devices making use of the transitional provisions under Article 120 of the MDR. As one can expect the changes consists of adjustments all over the document to align it to Regulation (EU) 2023/607 of the European Parliament and ...
State-of-the-Art in Clinical Evaluation Reports
In accordance with the Medical Device Regulation, manufactures must show that devices are safe and perform as intended, taking into account the generally acknowledged ‘state of the art’. This term can also be found in the MEDDEV 2.7/1 rev 4 guidance, which guidance also demands that the manufacturer presents a thorough description of the state ...
MDCG 2024-5 guidance on content of the Investigator’s Brochure for clinical investigations of medical devices
The MDCG has released a guidance document concerning the content of the investigator’s brochure for clinical investigations of medical devices. For some background, when a sponsor of a clinical investigation submits an application in accordance with article 70(1) of the MDR, the application shall be accompanied by the documentation referred to in Annex XV, Chapter ...
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 ...
