All In vitro diagnostics articles
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JournalIVDs and medical devices — post-market surveillance and clinical follow-up requirements
Written by Kirsten Van Garsse from Qarad (part of the QbD Group) based on an online seminar presentation, made in collaboration with TOPRA and QbD, given on 6 December 2022 by Kirsten Van Garsse and Anne-Sophie Grell from QbD.
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![[FROM LEFT] Claudia Popp, Olga Tkachenko and Marta Carnielli](https://ds982gbwnvyso.cloudfront.net/Pictures/100x67/4/4/1/441_5m4a4767_toprasymposium2022_day3_20221019_816643.jpg)
Meeting ReportIVD1: Current state –
and update on IVDR implementationThis session focused on the implementation of the IVDR which went live on 26 May 2022.
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Meeting ReportIVD2: Clinical Performance Evaluation Challenges
We are in a transition phase until EUDAMED is fully functional. Local Agency procedures must still be followed despite the IVDR go-live – this is administratively challenging.
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Meeting ReportIVD3: IVDR for small companies and start-ups
When developing novel products, small companies and start-ups must understand the regulatory pathways to market. NBs are providing support to industry in its transition to the EU Medical Device Regulation, but NBs are in high demand.
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JournalHarmonising regulation of medicinal allergen products throughout the European Union – the historic situation and subsequent CMDh guidance
Allergen products in the EU are defined as goods ‘intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent’. Historically, allergens were authorised under the national frameworks of member states (MS) with some legislation pre-dating the Treaty of Rome in 1957. This led to regulatory problems, such as pharmacovigilance monitoring standards. The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) addressed these authorisation issues and published a document on recommendations to common regulatory approaches for medicinal allergen products. This article provides an overview of the CMDh guidance, including a summary of some of the responses received during its consultation phase.
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Meeting ReportMD4: Clinical investigations – Is coordinated CA assessment the future?
The first speaker was Amy Bennet, who highlighted that any coordinated clinical assessment requires sound data gathered from preclinical development, especially in class IIa, IIb and above devices.
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Meeting ReportMD2: Global development strategy, which market should you go to first?
Michelle Lotte started the session. She summarised considerations of the MDD/MDR transition against submission to the FDA.