Tag: Guidance Documents

IVDR, MDR, News in Brief

EU UDI helpdesk available

June 10, 2021
Important Notice, IVDR

IVD or not IVD? That is the question…

April 15, 2021
Important Notice

Key guidance document on the classification of IVDs under the IVDR

December 1, 2020
Important Notice, MDR

Sufficient clinical evidence under the MDR for class I legacy devices

November 3, 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
News in Brief

Guidance checklist for manufacturers of reusable and resterilizable medical devices

September 3, 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
Important Notice

EU guidance on Notified Body clinical evaluation assessment reports

July 24, 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
COVID-19, Important Notice, News in Brief

Surgical and FFP masks in the COVID-19 crisis

May 8, 2020
Important Notice, MDR

Urgently Required MDR Guidance Documents for Clinical Evaluations and PMCF Published

April 29, 2020
COVID-19, Important Notice

European Commission gives details of how to prevent COVID-19 test failures

April 23, 2020
Important Notice, IVDR, MDR

MDR and IVDR guidance updates

April 9, 2020
COVID-19, Important Notice

Guidance on MD and PPE in times of COVID-19 and local provisions

April 9, 2020
Important Notice, News in Brief

European Commission Recommendation on Regulatory Exemptions for COVID-19 Products

March 23, 2020
Important Notice

New guidance documents for EMDN and cybersecurity

February 13, 2020
Important Notice

MDCG guidance documents on MDR codes and sampling of MDR and IVDR devices published

January 6, 2020
Important Notice

Guidance document for class I device manufacturers

December 23, 2019
News in Brief

Guidance on Qualification and Classification of Software under the MDR and IVDR Published

October 28, 2019
Important Notice, IVDR

Performance Evaluation for IVD Medical Devices

October 28, 2019
Important Notice

MDCG Guidance on MDD Certificates and SSCP under the MDR

October 15, 2019
Important Notice, News in Brief

Guidance on Person Responsible for Regulatory Compliance

June 23, 2019
News in Brief

Guidance on Implant Cards

June 23, 2019
Important Notice, News in Brief

Unique Device Identification (UDI) and Regulations (EU) 2017/745 on Medical Devices and 2017/746 on In Vitro Diagnostics

June 14, 2019
News in Brief

EU Guidance on Quality Rules for Drug-Device Combinations

June 4, 2019
News in Brief

The World Health Organisation’s (WHO) New Draft Guideline

May 28, 2019
News in Brief

Draft Policy on Remaining Shelf-Life for Medical Products

April 17, 2019
News in Brief

Updated Clinical Evaluation Guidance on Comparability

April 8, 2019
Important Notice, News in Brief

Device Registration and Legacy Devices

April 2, 2019
News in Brief

Guidance on Article 54(2)b of Regulation (EU) 2017/745 on medical devices (MDR)

March 22, 2019