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EU

Sertio Oy designated as EU Notified Body European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

Sertio Oy designated as EU Notified Body

Sertio Oy from Finland is designated as a notified body under the Regulation on In vitro Diagnostic Medical Devices (2017/746, IVDR). To date, there are twelve notified bodies designated under the EU IVDR. This designation was published on NANDO database on 31 October September 2023. This can be considered as significant news to the European diagnostics industry.
admin
November 3, 2023
Import Control System 2 for air cargo brought into Northern Ireland and the EU Membership NewsMembership News Archive

Import Control System 2 for air cargo brought into Northern Ireland and the EU

From 1 March 2023, full entry summary declarations will be needed for air cargo brought into Northern Ireland (NI) and European Union (EU) member states. This will need to be done through Import Control System 2 (ICS2), which is a new safety and security declaration system being introduced across the EU. The system will be implemented over three releases and…
Ben Kemp
February 16, 2023
MedTech Europe calls for action on energy crisis to reinforce healthcare capabilities Membership NewsMembership News Archive

MedTech Europe calls for action on energy crisis to reinforce healthcare capabilities

MedTech Europe have outlined the danger that the energy crisis poses the European healthcare sector alongside a call for action to EU and Member States in their paper Europe's Energy Crisis: Actions Needed to Reinforce Healthcare Capabilities. They claim that rocketing energy prices combined with foreseen energy supply disruptions across Member States, are severely impacting the production, assembly, delivery, and…
Natalie Creaney
September 30, 2022
Medicinal Products Working Group, Technical Barriers to Trade Specialised Committee and the UK-EU TCA updates HighlightsHighlights Archive

Medicinal Products Working Group, Technical Barriers to Trade Specialised Committee and the UK-EU TCA updates

Medicinal Products Working Group and Technical Barriers to Trade Specialised Committee update and call for any issues related to the UK-EU TCA: The Medicines and Devices (Goods) team remain ready to stand up the Medicinal Products Working Group (MPWG) and continue working to progress the forum. They have agreed a pragmatic compromise with the Commission that the Technical Barriers to…
Ben Kemp
July 1, 2022
European Commission publishes updated ‘Blue Guide’ Membership NewsMembership News Archive

European Commission publishes updated ‘Blue Guide’

The European Commission has published the new ‘Blue Guide on the implementation of the product rules 2022’. This was first published in 2000 and has been updated in 2014 and 2016. Given the New Legislative Framework which has been implemented in the EU, it was appropriate for a further update to take place. This latest update adds mention of (EU)…
Ben Kemp
July 1, 2022