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 ...
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 ...
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 ...
Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Although the MDR and IVDR define the terms importer and distributer and specify their respective obligations, certain aspects still remain unclear. In light of this, the MDCG has published a question and answer regarding Article 13 & 14 of the MDR and IVDR respectively, entitled MDCG 2021-27 with the aim of clarifying these aspects. The ...
MDCG 2022-18 Position Paper – Article 97 of the MDR
Toward the end of December 2022, the MDCG published a position paper aimed at providing a common understanding and approach to the application of Article 97 of the MDR. Giving some hope concerning devices that were certificated under the MDD but have expired since May 2021 or will expire before an MDR certificate is issued. ...
