Swissmedic announces new Swissdamed Database!

Posted on July 16, 2024 By MDSS

Swissmedic is pleased to announce the launch of Swissdamed, a new database designed to support the implementation of Swiss regulations for medical devices and in vitro diagnostic medical devices. The platform consists of two main modules and features a freely accessible search function. Key F...

UK flag in iconic background horizontal no flagpole 2024

MHRA, UK

MHRA proposes a framework for international recognition of medical devices!

Posted on July 15, 2024 By MDSS

The MHRA has announced a policy intent to recognize medical device regulatory approvals from Australia, Canada, the EU, and the USA, aiming to ensure safe access to quality devices and reduce assessment duplication. There is an ongoing discussions to include Japan on the recognition approva...

MDR, Switzerland

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...

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, 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...

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...

Swissmedic announces new Swissdamed Database!

MHRA proposes a framework for international recognition of medical devices!

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!

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)

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