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 ...
Guidance Document on the Questions & Answers Regarding Clinical Investigation has Been Updated – MDCG 2021-6 Rev.1
The MDCG has updated a guidance document initially published in 2021 regarding Clinical Investigations. The guidance document is in the form of a Question and Answer and contains a plethora of different questions and answers covering a variety of different scenarios for clinical investigations. The updated document sees the addition of a number of different ...
The First IVDR Reference Labs Have Been Designated
On December 5th, 2023, the EU Commission adopted implementing regulation (EU) 2023/2713 designating 5 European Union reference laboratories in the field of in vitro diagnostic medical devices. These 5 European Union reference laboratories will be involved in the conformity assessment of Class D in vitro diagnostic devices and other advisory tasks. The important tasks these ...
MDCG Publish Updated Position Paper – MDCG 2022-11 Rev.1
The MDCG has issued an update to a guidance document in the form of a position paper initially released in 2022 regarding a notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements. The updated position paper sees the addition of a new section entitled Call to notified bodies to ...
MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations. Guidance on MDSW intended to work in combination with hardware or hardware components.
It’s no secret that software has become an integral part of many medical devices on the EU market. It is estimated that a quarter of medical devices either incorporate a software or could be considered to be a medical device software in their own right. In many cases, the MDSW can only achieve its intended ...
Update to Manual on Borderline and Classification for Medical Devices Under Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In-Vitro Diagnostic Medical Devices
An update to the Manual on Borderline and Classifications under the MDR and IVDR has been published. The last update, version 2, was issued in December 2022, and since then has been updated to include the following devices: Root canal irrigation solutions, Temperature sensors embedded in orthopaedic devices for compliance tracking, System intended to produce ...
EUDAMED Updated to Version 2.12.
This month sees an updated EUDAMED, version 2.12 was deployed on 20th September 2023. It is important that all actors keep informed regarding these changes and how they may affect the use of EUDAMED. The release notes detailing new and updated elements can be found here: [Release Notes v2.12] The EUDAMED user guide for Economic ...
