EU buidings
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...
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Swiss Authorized Representative
Switzerland

IvDO adopted!

Posted on June 28, 2022 By MDSS
It is confirmed. Switzerland adopted the new Regulation on In-vitro Diagnostics (IvDO), which mainly refers to the IVDR. The provisional text in German language is available here. Now we need to wait for the final version to be published in the Swiss Federal Council website. Once it is published, c...
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EC Flags
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...
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News

No CE marking needed!

Posted on March 30, 2020 By mdss
On a regulatory level the EU allows important devices to be placed on the EU market without the CE mark relevant for the fighting of the COVID-19 crisis. Those are Products covered by Regulation (EU) 2016/425 on personal protective equipment (PPE) and medical devices covered by the Directive 93/42/E...
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corona
News, Covid-19

Statement on Covid-19

Posted on March 20, 2020 By mdss
The Covid-19 outbreak is rapidly changing lives and business practices worldwide. Increasingly stricter measures are being implemented to protect public health. During these difficult times the safety and well-being of our families, friends and colleagues are our highest priority. Authorized Represe...
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