ISO 20916:2019 Published

The first edition of “ISO 20196:2019 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice” has been published.

Implementing Decision UDI Issuing Entities

June 7th 2019 the Commission Implementing decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices appeared in the Official Journal of the European Union. This Implementing Decision is now also available on Vivaldi

LRQA Ceases as Notified Body

June 13th 2019 Lloyd’s Register Quality Assurance (LRQA) announced its withdrawal as Notified Body under the current Medical Device and IVD Directives and that it will not apply for designation under the Medical Device and IVD Regulations.

MDCG 2019-6: NB Q&A

The Medical Device Coordination Group issued a Q&A document to clarify new obligations under the medical device and in vitro diagnostic regulations (MDR/IVDR) regarding notified bodies (NBs).

MedTech Europe publishes MDR symbols guidance

MedTech Europe has prepared a guidance document in response to the new requirements in the Medical Devices Regulation (MDR) that ask for various kinds of information to be indicated on the label of medical devices.

Basic GMDN membership Free

The Global Medical Device Nomenclature (GMDN) has been made freely available to all users on 1st April 2019 through a new basic membership plan.

TÜV SÜD designated under EU MDR

Germany-based TÜV SÜD Product Service GmbH Zertifizierstellen (NB 0123) is now the second notified body (NB) to be designated and notified under the EU Medical Devices Regulation (MDR).

MHRA Guidance Virtual Manufacturer

The UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) has issued the second edition of the Guidance for Virtual Manufacturers. MHRA has replaced the term “Own Brand Labelling” (OBL) by “Virtual Manufacturer”.

Swiss MedTech Recommendation

April 25th, 2019 Swiss MedTech issued a recommendation to all its members, urging them to prepare to meet third-country requirements when it comes to marketing products in the EU under the EU Medical Device Regulation (MDR 2017/745).

Corrigenda to the Regulations

The Council of the European Union released two corrigenda as part of an effort to fix the mistakes, inconsistencies and slightly correct the EU’s Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR).

Medical Device Nomenclature

The Italian CND nomenclature is selected to support the IVDR and MDR implementation.

New version of the Borderline Classification Manual (v21) Published

The European Commission published a new revision (1.21) of the “Manual on borderline and classification in the community regulatory framework for medical devices.”

No-deal Brexit Impact.

The European Commission has posted on their website a Questions and Answers related to the UK’s withdrawal from the EU, in case of a no-deal scenario. While in the UK, new regulations that amend their 2002 Medical Device Regulations were laid down in parliament.

Eurospine - October 2019

Meet our International Sales Manager, Ms. Chantal Huysmans, in Helsinki on October 16 - 18, 2019!

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