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Concept of MDR Medical Device Regulation.

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)

21 December 2023 by Sam Attard

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 … Read more

MDCG 2021-27 Rev.1 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

21 December 2023 by Sam Attard

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 … Read more

MDCG 2023-6: Guidance on demonstration of equivalence for Annex XVI products

21 December 2023 by Sam Attard

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 … Read more

MDCG 2023-5: Guidance on qualification and classification of Annex XVI products.

21 December 2023 by Sam Attard

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 … Read more

Guidance Document on the Questions & Answers Regarding Clinical Investigation has Been Updated – MDCG 2021-6 Rev.1

21 December 202312 December 2023 by Ant Kirby

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 … Read more

The First IVDR Reference Labs Have Been Designated

21 December 20236 December 2023 by Ant Kirby

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 … Read more

The EU Commission Has Commissioned a Study Monitoring the Availability of Medical Devices on the EU Market

8 January 20242 December 2023 by Ant Kirby

The study is focusing on two key stakeholder groups, manufacturers and authorised representatives. The outcome of which, is to effectively monitor the availability of medical devices (including in-vitro diagnostic devices) on the EU market and the insights from these two key stakeholders are deemed essential. This study will be conducted repeatedly over a three year … Read more

MDCG Publish Updated Position Paper – MDCG 2022-11 Rev.1

21 December 20231 December 2023 by Ant Kirby

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 … Read more

MDR and IVDR Communication Survey

8 January 202427 November 2023 by Ant Kirby

The EU Commission published a survey in August 2023, this survey is due to close by the end of November 2023. It is only intended for stakeholders who are directly impacted by the regulatory changes for medical devices. That would seem to be a great number of organisations. The object of this survey is to … Read more

Team Notified Body Issue Call to Action for Manufacturers of Class D In-Vitro Diagnostic Medical Devices

4 March 202427 November 2023 by Sam Attard

In order to address the slow transition and prevent shortages of IVDs on the market, the amending regulation (EU) 2022/112 of 25 January 2022 introduced a stepped extension of transition periods based on the classification of the IVD. While the amending regulation has provided additional transitional time, the first deadline of 26 May 2025 for … Read more

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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)

MDCG 2021-27 Rev.1 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

MDCG 2023-6: Guidance on demonstration of equivalence for Annex XVI products

MDCG 2023-5: Guidance on qualification and classification of Annex XVI products.

Guidance Document on the Questions & Answers Regarding Clinical Investigation has Been Updated – MDCG 2021-6 Rev.1

The First IVDR Reference Labs Have Been Designated

The EU Commission Has Commissioned a Study Monitoring the Availability of Medical Devices on the EU Market

MDCG Publish Updated Position Paper – MDCG 2022-11 Rev.1

MDR and IVDR Communication Survey

Team Notified Body Issue Call to Action for Manufacturers of Class D In-Vitro Diagnostic Medical Devices

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