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European Commission Updates Regulatory Affairs Newsletter

European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU Notified bodies urging to submit Class D legacy devices’ application sooner

As the transitional deadlines for IVD devices are fast approaching, the Notified Bodies have communicated with MedTech Europe to encourage manufacturers to submit their applications for compliance with the IVD Regulation as early as possible. Manufacturers are urged to submit applications for Class D legacy devices before end-2023, in order to meet the deadline of 26 May 2025.
Ashleigh
May 12, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA has confirmed EU amendment to MDR will apply in Northern Ireland

MHRA have confirmed that the timeline extensions for the EU MDR will apply in Northern Ireland, and certificates that have been extended will be recognised as valid for placing CE marked devices on the Great Britain market. This comes after the EU passed an amendment to the EU MDR and EU IVDR to amend the transition timelines for medical devices,…
Ashleigh
March 31, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMembership News

EU IVDR amendment published in the OJEU

The amendment to the EU IVDR has been published in the Official Journal of the European Union. This removes the sell-off provision for IVD products, meaning that IVDs legally placed on the market under their IVDD certification can continue to be supplied to users indefinitely. This does not mean that new product can be placed on the market after expiry…
Ashleigh
March 24, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

MDCG guidance schedule

The MDCG have published their latest ongoing guidance update. The following IVDR-related documents are included in this list: Notified bodies Q&A on requirements notified bodies – update of MDCG 2019-6 (Permanent work item, no estimated date) Standards Updates of guidance document MDCG 2021-5 on standardisation for medical devices (Estimated Q2 2023) Post-market surveillance and vigilance Guidance on Post-Market Surveillance requirements (Estimated Q2…
Ashleigh
March 17, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter Archive

EU MDR/EU IVDR amendment approved by EU Council

On 7 March, the European Council unanimously approved the amendment to the EU MDR and EU IVDR. This amends the transitional provisions for the MDR and removes the sell-off provision for IVDs. This is expected to be published in the Official Journal of the European Union this month, which will be when it comes into force. MedTech Europe's press release…
Ashleigh
March 9, 2023
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Team-NB position paper published: guidance for submission of technical documentation

Team-NB have published the position paper Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Device Regulation (EU) 2017/746. This is listed as "Team-NB PositionPaper BPG-IVDR V1" on the Team-NB website. Please note that although this is a guidance document published by a collective group of Notified Bodies, it is…
Ashleigh
March 9, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter Archive

EMA pilot launched for expert panels on high risk medical devices

For class III implantable devices, class IIb active devices intended to administer or remove medicinal products from the body, and Class D in vitro diagnostic medical devices, the Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) require notified bodies to consult expert panels before issuing a CE certificate. EMA is now running a pilot that enables the expert panels to…
Ashleigh
March 9, 2023
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