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.
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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.
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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.
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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.
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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
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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.
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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).
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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.”
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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.
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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.
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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).
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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”.
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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).
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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).
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Medical Device Nomenclature
The Italian CND nomenclature is selected to support the IVDR and MDR implementation.
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