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COVID-19

SARS-CoV-2 IVD tests and the IVDR

October 7, 2021
COVID-19, News in Brief

The European Commission publishes important guidance on the requirements for COVID-19 tests under the IVDD

August 5, 2021
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Guidance document on the impact of genetic variants on SARS-COV-2

May 29, 2021

News In Brief, Important Notice

Important Notice, IVDR, News in Brief

European Commission proposal for progressive roll-out of the IVDR adopted

January 5, 2022
MDR, News in Brief

bsi white paper on clinical evaluations

December 15, 2021
IVDR, MDR, News in Brief

MDCG guidance document on distributors and importers published

December 12, 2021
European Authorized Representation for Manufacturers of Medical Devices mdi Europa - EU flags in front of EU parliament
Important Notice, IVDR, MDR, News in Brief

European Commission EUDAMED website expanded

December 6, 2021
MDR, News in Brief

New guidance on legacy devices published

November 12, 2021
IVDR, MDR, News in Brief

IEC about to publish new standard on cybersecurity

November 10, 2021

News on Brexit

Consultation on amending UK medical devices regulations

December 2, 2021

Additional MHRA guidance for medical device companies

January 17, 2021

Latest UK MHRA updates on Northern Ireland and EU device regulation guidance

October 26, 2020

New UKCA mark after Brexit

September 17, 2020

Brexit and the regulatory situation for the medtech industry

February 3, 2020

News on Brexit

October 29, 2019

New Guidance for the UK Responsible Person Published

September 26, 2019

United Kingdom (UK) to Request ‘UK Responsible Person’

August 19, 2019

News in Brief

European Commission proposal for progressive roll-out of the IVDR adopted

January 5, 2022

New artificial intelligence regulations could lead to unnecessary burdens

December 29, 2021

bsi white paper on clinical evaluations

December 15, 2021

News In Brief

Important Notice, IVDR, News in Brief

European Commission proposal for progressive roll-out of the IVDR adopted

It is now officially confirmed – Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) will see a progressive roll-out as previously proposed by the European Commission. This was… Read More

January 5, 2022
CE Marking, Download Section Service, Guidance Documents, IVDR Service, Legislation Documents, Library, MDR Service

Complete Download Section mdi Europa

The section below is intended for all parties who are involved in the manufacturing of medical devices including in vitro diagnostic medical devices. You will find more than 50 important… Read More

December 18, 2021
MDR, News in Brief

bsi white paper on clinical evaluations

One of the main concerns when planning towards compliance with Regulation (EU) 2017/745 on medical devices (MDR) is the clinical evaluation. According to article 61 of the MDR, manufacturers must… Read More

December 15, 2021
IVDR, MDR, News in Brief

MDCG guidance document on distributors and importers published

The Medical Device Coordination Group (MDCG) has issued a new guidance document “to provide further detail on the operational and practical implementation of Articles 13 and 14 and other related… Read More

December 12, 2021
European Authorized Representation for Manufacturers of Medical Devices mdi Europa - EU flags in front of EU parliament
Important Notice, IVDR, MDR, News in Brief

European Commission EUDAMED website expanded

In earlier newsletter issues, we reported that additional EUDAMED modules were made available. In parallel, the European Commission expanded the website and associated subject areas with tabs for each module.… Read More

December 6, 2021
MDR, News in Brief

New guidance on legacy devices published

The Medical Device Coordination Group (MDCG) has issued another guidance document, MDCG 2021-25. The document provides further guidance on certain open questions around how Regulation (EU) 2017/745 on medical devices… Read More

November 12, 2021
IVDR, MDR, News in Brief

IEC about to publish new standard on cybersecurity

The International Electrotechnical Commission (IEC) plans to issue the new cybersecurity standard IEC 81001-5-1 soon. It deals with how IT security must be considered in the software life cycle. As… Read More

November 10, 2021
Important Notice, IVDR

Extended IVDR transition period for certain IVD medical devices

The European Commission has given in and makes concessions to the industry. On October 14, 2021 the Commission issued the corresponding proposal for a partial delay of Regulation (EU) 2017/746… Read More

October 25, 2021

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