MDCG Archives

Guidance for Clinical Investigation Plan under MDR: Key Highlights!

Posted on March 18, 2024 By MDSS

The latest guidance document from the Medical Device Coordination Group, – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices, was just published. The process of submitting an application for a clinical investigation under Article 70(1) o...

MDR, News

Flowchart for determining eligibility under the extended MDR transitional period for Devices

Posted on September 6, 2023 By MDSS

The Commission just published a Flowchart to assist manufacturers and stakeholders in determining device coverage under the extended transitional period of the MDR. The purpose of the flowchart is to aid manufacturers and other relevant stakeholders in making a determination about the inclusion of ...

News

New MDCG guidance documents!

Posted on April 29, 2020 By mdss

The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. Legally non-binding guidance documents, adopted by the medical device coordination group (MDCG) in accordance with Article 105 of Regulation 745/2017, pursue the obj...

News

Agenda of the MDCG and the MDCG subgroups has been released!

Posted on January 24, 2020 By mdss

The MDCG has been created according to Article 103 and the subgroups were implemented in 2019. The task are defined in Article 105 (see below). Most likely we will see an increase of new documents and hopefully new notified bodies after each MDCG meeting. Article 103 Medical Devcie Coordinating G...

News

IMPORTANT, Important … Guidance for class I manufacturer!

Posted on December 19, 2019 By mdss

MDCG 2019-15 – Guidance Notes for manufacturers of class I Medical Devices was published last Tuesday, the 17th of December. And other guidance have been published which are also important. MDCG 2019-14 Explanatory note on MDR codes MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class I...

News

Guidance on software classification & other documents

Posted on October 15, 2019 By mdss

The European Commission indeed works hard to provide further clarification on a number of aspects. Documents are now being issued frequently. It is great that long awaited clarification is being provided! However, stakeholder criticism is that some of the MDCG documents not only clarify aspects, but...

News

New information on expert panels published

Posted on October 2, 2019 By mdss

The MDR/IVDR envisages expert panels, who shall assist the European Commission, the Medical Devices Coordination Group, Member States, Notified Bodies and manufacturers in technical, scientific and clinical aspects. Now a decision of the European Commission (Implementing Decision (EU) 2019/1396) has...

Guidance for Clinical Investigation Plan under MDR: Key Highlights!

Flowchart for determining eligibility under the extended MDR transitional period for Devices

New MDCG guidance documents!

Agenda of the MDCG and the MDCG subgroups has been released!

IMPORTANT, Important … Guidance for class I manufacturer!

Guidance on software classification & other documents

New information on expert panels published

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