Skip to main content
search
Tag

IVDR

UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (20 Feb)

Please note this is an extract of the original bulletin. Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU Page summary: The EU Commission has voted to adopt an extension of the transition period for the EU Medical Device Regulations and to extend the validity of certain device certificates Change made: First…
admin
March 9, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter Archive

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…
admin
March 9, 2023
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter Archive

MedTech Europe survey results: Transition to the IVD Regulation

MedTech Europe have published their Survey Report Transition to the IVD Regulation - MedTech Europe Survey Results for October 2022. This report can be found on the MedTech Europe website. The results demonstrate that there are still bottlenecks occurring throughout the IVDR implementation, and indicates where additional attention is needed.    
admin
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…
admin
March 9, 2023
Membership NewsMembership News Archive

BIVDA reacts to the IVDR legislation coming into effect on Thursday

Thursday marked the date of application of the in vitro diagnostic regulation. This regulation applies to IVDs placed on the market in the European Union and Northern Ireland, bringing with it a heightened regulatory regime. BIVDA have released a full press release to celebrate this new chapter of IVD regulation. Please see the text below: BIVDA welcomes the In Vitro…
Natalie Creaney
May 27, 2022
Membership NewsMembership News Archive

New paper highlights overlap in EU and US requirements to support efficient compliance

Members may find this white paper useful in ascertaining EU IVDR clinical evidence requirements and how manufacturers can efficiently comply. It is imperative that manufacturers do not underestimate the time required to source the right clinical evidence for their products. As the risk to individual and public health increases with each device classification under the IVDR, the corresponding conformity assessment…
Ben Kemp
April 8, 2022
Close Menu