MDR 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

WARNING – for all Manufacturers of MDD CE legacy products!

Posted on January 23, 2024 By MDSS

DEADLINE – May 26, 2024! ACT NOW! Submitt your application to your Notified Body and keep your foot on the gas. Keep all your MDD legacy products on the EU Market, even if your MDD certificate expired or is about to expire! Conditions apply – see Article 120 MDR Article 120 –...

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

Exciting developments regarding Harmonized Standards!

Posted on May 21, 2020 By mdss

M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation (EU) 2017/745 of the European Parliament and...

News

For risk class I manufacturer!

Posted on January 23, 2020 By mdss

Warning: No additional transition for risk class I products. Products who are risk class I and stay of risk class I must fully comply to the MDR by May 2020. Please consider the MDCG guidance Guidance Notes for Manufacturers of Class I Medical Devices cover.pdf – December 2019. I...

News

Use of Symbols to Indicate Compliance with the MDR!

Posted on January 15, 2020 By mdss

MedTech Europe issued in December an update on the List of Symbols.pdf, which may be useful to consider in particular for the transition to the MDR. For example it provides the indication that a device is a medical device. As always, as long they are not harmonized, they must be repeated in the IFU...

News

New documents published by the Commission!

Posted on January 15, 2020 By mdss

– The European Medical Device Nomenclature (EMDN) – the nomenclature of use in EUDAMED! The European Medical Device Nomenclature (EMDN) will be the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. – The CND Nomenc...

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

New Vigilance documents published on the European Commission website!

Posted on December 16, 2019 By mdss

The following important vigilance documents have been published on the European website: Additional guidance on the MEDDEV 2.12/1 rev.8 Device specific vigilance guidance (if applicable): Cardiac ablation vigilance reporting guidance Coronary stents vigilance reporting guidance Cardiac implantable...

News

European Commission offers Guidance on UDIs!

Posted on December 15, 2019 By mdss

Last Wednesday, the 4th of December 2019, the European Commission released new documents related to the technical specifications for unique device identifiers (UDIs). GS1 Basic UDI-DI HIBCC Basic UDI-DI ICCBBA UDI HRI & AIDC Formats HIBCC UDI HRI & AIDC Formats ICCBBA Basic UDI-DI IFA Basi...

Guidance for Clinical Investigation Plan under MDR: Key Highlights!

WARNING – for all Manufacturers of MDD CE legacy products!

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

Exciting developments regarding Harmonized Standards!

For risk class I manufacturer!

Use of Symbols to Indicate Compliance with the MDR!

New documents published by the Commission!

IMPORTANT, Important … Guidance for class I manufacturer!

New Vigilance documents published on the European Commission website!

European Commission offers Guidance on UDIs!

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