Systems and procedure packs In other articles I discussed grouping devices into the Basic UDI-DI, and also the strategic importance of the Basic UDI-DI from a regulatory perspective. This article sets out how UDI is used for the identification of systems and procedure packs. Article 22 defines a system of procedure pack as a combination … Read more
The strategic consequences of specific Basic UDI-DI groupings As can be read elsewhere, a Basic UDI-DI groups devices with the same intended purpose and the same essential design and manufacturing characteristics into device families. Within this context a company can chose to apply various levels of granularity. This freedom should be used with great caution, … Read more
Basic UDI-DI MDCG guidance 2018-1 Rev. 4 starts with: ‘The Basic UDI-DI is the main key in the database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) to connect devices with same intended purpose, risk class and essential design and manufacturing characteristics.’ In order to help … Read more
EUDAMED is the IT system established by Regulation (EU) 2017/74) on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices and developed by the European Commission. A device identification system based on a unique device identifier (UDI) allows easier traceability of medical devices. Really, EUDAMED and UDI are in essence quite straightforward … Read more
This training is specific for PRRCs that are working in-house at manufacturers of medical devices and IVDs. This NOT for outsourced PRRCs and PRRCs working for an authorized representative. When This training will be provided on 19 and 26 February 2024 at 16:00 – 18:00 CET (Amsterdam time) Who should participate This training is for … Read more
This training is specific for PRRCs that are working in-house at authorized representatives. This NOT for outsourced PRRCs and PRRCs working for a manufacturer. When This training will be provided on Tuesday 5 and 11 March 2024, 16:00-18:00 CET (Amsterdam time) Who should participate This training is for PRRCs that want to work within an … Read more
This training is specific for PRRCs that are working in-house at authorized representatives. This NOT for outsourced PRRCs and PRRCs working for a manufacturer. When This training will be provided on Tuesday 23 and 30 April 2024 at 10:00 – 12:00 CET (Amsterdam time) Who should participate This training is for PRRCs that want to … Read more
Short description This training is specific for PRRCs that are outsourced to manufacturers of medical devices and IVDs. This NOT for in-house PRRCs and PRRCs working for an authorized representative. When This training will be provided on Tuesday 14 and 21 May 2024 at 16:00 – 18:00 CET (Amsterdam time) Who should participate This training … Read more
Short description This training is specific for PRRCs that are outsourced to manufacturers of medical devices and IVDs. This NOT for in-house PRRCs and PRRCs working for an authorized representative. When This training will be provided on Tuesday 8 and 15 April 2024 at 16:00 – 18:00 CET (Amsterdam time) Who should participate This training … Read more
Short description This training is specific for PRRCs that are outsourced to manufacturers of medical devices and IVDs. This NOT for in-house PRRCs and PRRCs working for an authorized representative. When This training will be provided on Tuesday 20 and 27 February 2024 at 16:00 – 18:00 CET (Amsterdam time) Who should participate This training … Read more
Boumans Regulatory Consulting BV
