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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

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Important Notice, IVDR, MDR, News in Brief

New MDCG guidance documents under the MDR and IVDR

June 7, 2022
Important Notice, MDR, News in Brief

New guidance on borderline products between drugs and medical devices under the MDR

June 1, 2022
Important Notice, IVDR, News in Brief

MDCG publishes guidance on significant changes for legacy products under the IVDR

May 11, 2022
mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!
Important Notice, IVDR, MDR, News in Brief

EUDAMED update on timelines

April 10, 2022
Important Notice, News in Brief

Ukraine tries to maintain business as usual

April 6, 2022
Important Notice, IVDR, News in Brief

IVD medical devices after the IVDR date of application 

March 12, 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

New MDCG guidance documents under the MDR and IVDR

June 7, 2022

New guidance on borderline products between drugs and medical devices under the MDR

June 1, 2022

MDCG publishes guidance on significant changes for legacy products under the IVDR

May 11, 2022

News In Brief

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

New MDCG guidance documents under the MDR and IVDR

There certainly is a backlog in guidance especially related to the IVDR. In May, however, the Medical Device Coordination Group (MDCG) has issued a number of documents that may help… Read More

June 7, 2022
Important Notice, MDR, News in Brief

New guidance on borderline products between drugs and medical devices under the MDR

The Medical Device Coordination Group (MDCG) has published MDCG 2022-5, Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices. We highly recommend to… Read More

June 1, 2022
Important Notice, IVDR, News in Brief

MDCG publishes guidance on significant changes for legacy products under the IVDR

The Medical Device Coordination Group (MDCG) has recently issued guidance MDCG 2022-6, Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR. Article 110(3) of the… Read More

May 11, 2022
mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!
Important Notice, IVDR, MDR, News in Brief

EUDAMED update on timelines

The European Commission has published new timelines related to EUDAMED. The Commission expects EUDAMED to be fully functional in Q2 of 2023. The corresponding publication in the Official Journal of… Read More

April 10, 2022
Important Notice, News in Brief

Ukraine tries to maintain business as usual

The medical supply chain in Ukraine has been severely thrown into disarray because of the Russian military invasion. One of their biggest problems is a shortage of medicines, medical devices… Read More

April 6, 2022
News in Brief

New cybersecurity standard 

The requirements of the cybersecurity standard for medical devices, which was published a short time ago, surpasses what regulators are now looking for from medical device manufacturers.  The new standard… Read More

April 2, 2022
Important Notice, IVDR, News in Brief

IVD medical devices after the IVDR date of application 

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) will become fully applicable on May 26, 2022. In this context, we would like to draw the reader’s attention to… Read More

March 12, 2022
IVDR, News in Brief

New guidance for notified bodies of MDD/ AIMDD legacy device certificates and IVDR class D devices

The European Commission has issued new guidance documents that concern the activities of notified bodies under Regulations (EU) 2017/745 and 2017/746 (MDR and IVDR). MDCG 2022-3 provides clarification on verification… Read More

March 4, 2022

In our Customers own Words

We are having your guidance more than expected.

S. Mittal · Mediplus (India) Ltd.

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