October 2024 WMA issued a new version of the Declaration of Helsinki. Most striking changes include:
Lees meerJuly 4th the EU Commission organised an information session on MDR/IVDR for international regulators. In case you missed it, please herewith find the presentation: https://health.ec.europa.eu/document/download/93e2d43c-9da8-40b1-b6d8-8f36962c92f9_en?filename=ev_20240704_presentation.pdf
Lees meerhttps://www.toetsingonline.nl/to/ccmo_web.nsf/CCMO.xsp?page=home New submissions to be done via the new Research Portal. Submissions in review will still be processed through the current system.
Lees meerhttps://www.nationalbreastcancer.org/about-breast-cancer/ Be aware of what you can do to be proactive with your breast health.
Lees meerNote the new Research Portal going live has been postponed until February 2025.
Lees meerhttps://www.iso.org/standard/83968.html A new version of ISO14155 is currently under development, and on 20-JUN-2024 ISO/DIS 14155, replacing ISO14155:2020 when ready, entered the voting phase that terminates on 12-SEP-2024. A couple of interesting elements are in (potentially) impacting riskmanagement and safety for medical device clinical investigations (note the scope seems to have widened no longer excluding IVDs), […]
Lees meerEU commission issues an updated planning for gradual roll out of the EUDAMED modules, however, the timeline for delivery of the clinical investigations / performance studies module has been set yet. In other words we are still stuck with local approaches when it comes to adverse event reporting to the regulatory bodies involved in clinical […]
Lees meerhttps://health.ec.europa.eu/document/download/daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en?filename=mdcg_2024-10_en.pdf By nature ‘orphan devices’ are intended for use in a small number of individuals. This leads to specific challenges for manufacturers and notified bodies on the clinical evidence requirements for the purposes of MDR certification. This MDCG guideline presents guidance on circumstances where it is acceptable to place an orphan device on the market […]
Lees meerReferencing Annex B of ISO14155:2020, MDCG issues guidance on the investigator’s brochure: https://health.ec.europa.eu/document/download/ee7ee8eb-841a-4085-a8dc-af6d55ebf1bd_en?filename=mdcg_2024-5_en.pdf
Lees meerhttps://health.ec.europa.eu/latest-updates/mdcg-2024-4-safety-reporting-performance-studies-vitro-diagnostic-medical-devices-under-regulation-2024-04-15_en
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