The latest news

Important News for IVD and MD Manufacturers!

Posted on April 25, 2024 By MDSS

The European Parliament has adopted new measures, initially proposed by the Commission in January 2024, to improve the availability of in vitro diagnostics (IVDs), launch of parts of the European database on medical devices, Eudamed, and a mandatory prior notice in case disruption of supply is anti...

MDCG documents, News

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...

News

MDSS receives their ISO 13485 Certificate from BSI!

Posted on February 27, 2024 By MDSS

We’re thrilled to announce that we have received our new ISO 13485 certification from BSI, marking a significant achievement in our commitment to quality and compliance. This certification, received from BSI, a globally recognized certification body, reinforces our dedication to maintaining ...

IVDR, News

Commission proposal on extending IVDR transition and expediting EUDAMED adoption!

Posted on January 26, 2024 By MDSS

Due to concerns about manufacturers facing challenges in meeting the In Vitro Diagnostic Medical Devices Regulation (IVDR) requirements within the allotted time, the European Commission (EC) is once again suggesting an extension of the regulation’s transition period. Simultaneously, the Commi...

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 –...

IVDR, MDR, News

Overview of language requirements for manufacturers of medical devices

Posted on January 22, 2024 By MDSS

The European Commission, in collaboration with Member States, has recently released two essential documents outlining language requirements under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Medical Device Regulation). These comprehensive tables have been designed as indispensab...

IVDR, News

Navigating medicinal products development and assessment involving companion diagnostics: A guide to addressing key questions under Regulation 2017/746 (IVDR)

Posted on January 17, 2024 By MDSS

This Q&As document outlines the European Medicines Agency’s (EMA) perspective on critical issues related to the development and assessment of medicinal products, especially those involving companion diagnostics (CDx), following the implementation of Regulation 2017/746 (IVDR). It aims to o...

News

Historic deal reached on World’s first AI Regulations – The Artificial Intelligence Act!

Posted on December 12, 2023 By MDSS

The Council presidency and negotiators from the European Parliament have achieved a preliminary accord on the proposal for harmonized regulations governing artificial intelligence (AI), known as the Artificial Intelligence Act. This drafted regulation is designed to guarantee the safety of AI syste...

News

EU survey alert: Share your thoughts on medical device regulations (MDR/IVDR)!

Posted on December 6, 2023 By MDSS

EC survey for MD and IVD manufacturers and AR on the status of the MDR/IVDR implementation! This survey is being endorsed by the European Commission (DG SANTE/HaDEA) to gather information and data regarding the progress of implementing Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVD...

News

Medtech Europe position paper on the future of Europe’s Medical Technology Regulations!

Posted on November 12, 2023 By MDSS

MedTech Europe is outlining the obstacles that medical technologies encounter within the European regulatory framework. According to the latest information, there are more than 35,000 medical technology companies in Europe, with 92% of them being small and medium-sized enterprises (SMEs). These comp...

Important News for IVD and MD Manufacturers!

Guidance for Clinical Investigation Plan under MDR: Key Highlights!

MDSS receives their ISO 13485 Certificate from BSI!

Commission proposal on extending IVDR transition and expediting EUDAMED adoption!

WARNING – for all Manufacturers of MDD CE legacy products!

Overview of language requirements for manufacturers of medical devices

Navigating medicinal products development and assessment involving companion diagnostics: A guide to addressing key questions under Regulation 2017/746 (IVDR)

Historic deal reached on World’s first AI Regulations – The Artificial Intelligence Act!

EU survey alert: Share your thoughts on medical device regulations (MDR/IVDR)!

Medtech Europe position paper on the future of Europe’s Medical Technology Regulations!

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