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COVID-19 Special

COVID-19, News in Brief

New guidance for third-country manufacturers of COVID-19 IVD tests

February 6, 2022
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

News In Brief, Important Notice

CE Marking Service, EU Authorized Representative Service, Important Notice

mdi Europa at Medica

October 5, 2022
Important Notice, News in Brief

Danger of cybersecurity attacks?

September 26, 2022
mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!
Important Notice, News in Brief

EU’s Implementing Regulation on Common Specifications for class D IVDs

September 6, 2022
Important Notice, News in Brief

Different options for IVD medical devices until Eudamed becomes fully operational

September 2, 2022
Important Notice, IVDR, MDR, News in Brief

Updated Blue Guide and MDR and IVDR harmonized standards

July 14, 2022
MDR, News in Brief

CAMD working group publishes Q&A document regarding FSCs

July 11, 2022

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

News on useful publications: MDCG borderline manual and bsi white paper on performance evaluations

October 13, 2022

Criticism on the EU’s 19-Point Regulatory Action Plan

October 11, 2022

Danger of cybersecurity attacks?

September 26, 2022

News In Brief

News in Brief

News on useful publications: MDCG borderline manual and bsi white paper on performance evaluations

A subgroup of the Medical Device Coordination Group (MDCG) published its first borderline manual under the medical device regulations titled “Manual on borderline and classification for medical devices under Regulation… Read More

October 13, 2022
News in Brief

Criticism on the EU’s 19-Point Regulatory Action Plan

The European Commission’s Medical Device Coordination Group (MDCG) has recently published a position paper on the transition to Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic… Read More

October 11, 2022
Important Notice, News in Brief

Danger of cybersecurity attacks?

The European Union Agency for Cybersecurity (ENISA) has warned that there is a danger of attacks on devices and digital health systems despite measures under Regulations (EU) 2017/745 and 2017/746… Read More

September 26, 2022
mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!
Important Notice, News in Brief

EU’s Implementing Regulation on Common Specifications for class D IVDs

The European Commission adopted Implementing Regulation (EU) 1022/ 1107. It is outlining the Common Specifications (CS) for certain class D IVD medical devices (including SARS-CoV-2 tests) in the context of… Read More

September 6, 2022
Important Notice, News in Brief

Different options for IVD medical devices until Eudamed becomes fully operational

The European commission has recently announced that Eudamed will not be fully operational until the second quarter of 2024. Under Regulation (EU) 2017/745 on medical devices (MDR), a guidance document… Read More

September 2, 2022
Important Notice, IVDR, MDR, News in Brief

Updated Blue Guide and MDR and IVDR harmonized standards

The European Commission keeps publishing new documents. A key document that provides the regulatory foundation for many CE marked devices, among others medical and IVD medical devices is the Blue… Read More

July 14, 2022
MDR, News in Brief

CAMD working group publishes Q&A document regarding FSCs

The Competent Authorities for Medical Devices (CAMD) working group recently published a Q&A document on free sales certificates (FSCs) under Regulation (EU) 2017/745 on medical devices (MDR). A legalized FSC… Read More

July 11, 2022
News in Brief

EU has to deal with discords between AI and medical device rules

The EU’s proposal for a new Artificial Intelligence (AI) act could upset the regulation and the supply of medical devices. The current proposal comes in addition to medical device legislation.… Read More

July 1, 2022

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