Important News from Swiss Medtech for medical device Manufacturers, Importers and Distributors!

Posted on May 1, 2024 By MDSS

New guidelines have been released detailing the regulatory requirements for placing “legacy devices” on the Swiss market. This is essential to ensure you can sell-off all your legacy medical devices after 26.05.2024. It is particularly critical for devices that have not yet been recert...

IVDR, MDR

Important News for IVD and MD Manufacturers!

Posted on April 25, 2024 By MDSS

Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices was published in ...

MDCG documents, MDR

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...

IVDR, MDR

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

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...

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, MDCG documents, MDR

Key Terms in the Medical Device Regulation

Posted on February 16, 2023 By MDSS

Key Terms and Concepts in the Medical Device Regulation – Vigilance The vigilance requirements under the EU’s medical device regulations can be complex and confusing. To help you navigate this landscape, the Medical Device Coordination Group (MDCG) has released a guide to key terms and c...

News, MDCG documents, MDR, MDR

EU MDR Bridge

Posted on December 16, 2022 By MDSS

EU MDR Bridge Deadline/transition – further info! What else happened last Friday, next to the proposed extension of the MDR Deadline for legacy products (see our Newsletter from Monday)? The MDCG 2022-18, a very special guidance, was published, intended to guide in particular authorities, to h...

News, MDR

Warning – For risk class I devices!

Posted on March 13, 2020 By mdss

Products, which stay class I under the MDR, must be in full compliance by May 26 2020! MDSS concern: Some clients seem to be under the impression that there was an extension given until May 2024 due to the MDR second corrigendum. This is not true. MDSS concern: Clients who have class I devices and ...

Important News from Swiss Medtech for medical device Manufacturers, Importers and Distributors!

Important News for IVD and MD Manufacturers!

Guidance for Clinical Investigation Plan under MDR: Key Highlights!

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

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

Key Terms in the Medical Device Regulation

EU MDR Bridge

Warning – For risk class I devices!

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