UDI Technical Documentation

The European Commission published eight documents related to the technical specifications for unique device identifiers (UDIs).

2nd IVDR Corrigendum

The European Parliament’s Committee on the Environment, Public Health and Food Safety voted to adopt a second corrigendum to the IVD Regulation 2017/746. This second round of corrigenda (MDR and IVDR) still have to be approved by Parliament.

2nd MDR Corrigendum

The Council of the European Union has published a second corrigendum for the EU’s Medical Devices Regulation (MDR).

EUDAMED delayed

The European Commission confirmed that EUDAMED will be delayed by two years. EUDAMED’s launch will therefore be done together for medical and in-vitro diagnostic medical devices, at the original date foreseen for in-vitro medical devices i.e. May 2022.

MDCG Guidance on Software Qualification and Classification

On October 11th the European Commission released MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR.

First NB designation under the IVDR

DEKRA Certification GmbH in Germany (DEKRA) is the first Notified Body officially designated for the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).

MIR v7.2 and two new Device Specific Vigilance Guidanc

European Commission has posted on their website version 7.2 of the template for a Manufacturer Incident Report (MIR), and its accompanying help text on how to complete the form. This template will become mandatory as of January 1st, 2020 for incidents under the MDD/AIMDD or IVDD, or for serious incidents under the MDR or IVDR.

MDCG Issues Guidance on SSCP

European Commission released MDCG 2019-9 Summary of safety and clinical performance - A guide for manufacturers and notified bodies.

EC publishes additional Guidance on Vigilance

July 10th, 2019 the European Commission published “Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8”. This guidance complements the MEDDEV 2.12-1 rev.8, dated January 2013.

UL Ceases as Notified Body

July 8th, 2019 UL International (UK) Ltd. (NB 0843) announced via a press release that they will be ceasing their notified body operations in the UK.

MDCG Issues Guidance on PRRC and Implant Cards

On July 1st the European Commission released two new guidance documents. The first, MDCG 2019-7, is focussed on Article 15 of the MDR and IVDR regarding a “Person Responsible for Regulatory Compliance” (PRRC) and the second, MDCG 2019-8, is focussed on the implant card required under Article 18 of the MDR.

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

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.

New version of the Borderline Classification Manual (v1.22) Published

The European Commission published a new revision (1.22) of the “Manual on borderline and classification in the community regulatory framework for medical devices.”

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.

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