Category: CE Consulting

IVDR, MDR, News in Brief

EU clearance for MDR and IVDR harmonised standards

May 28, 2021
IVDR, MDR, News in Brief

EU – Switzerland MRA expired

May 27, 2021
IVDR, MDR, News in Brief

Guidance on legacy devices regarding Eudamed

May 3, 2021
Important Notice, IVDR, MDR

New guidance documents published by the European Commission

May 2, 2021
Important Notice, IVDR

IVD or not IVD? That is the question…

April 15, 2021
Important Notice, IVDR, MDR

Updated EUDAMED implementation dates

April 1, 2021
Important Notice, IVDR, MDR

MDCG guidance on administrative practices and technical alternatives until EUDAMED full functionality

March 15, 2021
IVDR, MDR, News in Brief

Voluntary registration with EUDAMED database – industry fears duplicate registrations

January 23, 2021
Important Notice, MDR

mdi Europa experience on MDR technical documentation reviews

January 14, 2021
IVDR, News in Brief

EU IVD medical devices sector destined for crisis?

November 6, 2020
Important Notice, MDR

Sufficient clinical evidence under the MDR for class I legacy devices

November 3, 2020
IVDR, MDR, News in Brief

New website on actor registration in EUDAMED 3 available

October 29, 2020
IVDR, MDR, News in Brief

Practical advice for setting up an MDR and IVDR compliant PMS Plan

October 22, 2020
IVDR, MDR, News in Brief

Get ready for the economic operator registration in EUDAMED

October 9, 2020
IVDR, MDR, News in Brief

EUDAMED economic operator registration module available as of December 2020

September 16, 2020
MDR, News in Brief

Commission to put forward another European standards request

August 24, 2020
IVDR, MDR, News in Brief

New guidance document shows how to use MDSAP audit reports for MDR/ IVDR surveillance audits

August 21, 2020
IVDR, MDR, News in Brief

Updated Q&A document on MDR and IVDR UDI requirements from the European Commission

August 12, 2020
MDR, News in Brief

ISO TR 20416 and PMS under the MDR

August 1, 2020
MDR, News in Brief

European Commission’s device standardisation request rejected

June 23, 2020
MDR, News in Brief

Updated timetable for Eudamed

June 7, 2020
Important Notice, MDR

Clinical evaluation and equivalence – using literature under the MDR

June 5, 2020
IVDR, MDR, News in Brief

New MDR and IVDR guidance documents published by MDCG and MedTech Europe

June 1, 2020
Important Notice, MDR

Urgently Required MDR Guidance Documents for Clinical Evaluations and PMCF Published

April 29, 2020
Important Notice, MDR

MDR Postponed by One Year!

April 28, 2020
Important Notice, MDR

MDR Postponement – Handle with Care!

April 21, 2020
Important Notice, IVDR, MDR

MDR and IVDR guidance updates

April 9, 2020
Important Notice, MDR

Latest MDCG Preparedness Plan and MDR Delay

March 26, 2020
Important Notice, MDR

Second MDR corrigendum published

December 18, 2019
Important Notice, IVDR

Performance Evaluation for IVD Medical Devices

October 28, 2019
CE Consulting, EU Authorized Representative

A True Story about Trust and Guidance

August 18, 2019
CE Marking, MDR

Technical Documentation Requirements under the MDR – a Case Study

January 14, 2019
CE Consulting, IVDR, MDR

Notified Body Selection and Change

December 15, 2018