The Basic UDI-DI provides the basis to your regulatory approach. If done well, it can drive the structure of the technical documentation and registrations in EUDAMED. Find out what such strategy should look like and how I can help.
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 section is about: Regulation (EU) 2023/607 Regulation (EU) 2023/607 on MDR transitional arrangements allows for manufacturers of devices that were certified under the ‘old’ Directives to remain certified as such for some years to come, while they wait until they become certified under the MDR. In general, this will require the manufacturer to prepare … Read more
This section is about: Regulation (EU) 2023/607 Regulation (EU) 2023/607 on MDR transitional arrangements allows for manufacturers of devices that were certified under the ‘old’ Directives to remain certified as such for some years to come, while they wait until they become certified under the MDR. In general, this will require the manufacturer to prepare … Read more
Note: new text is in bold Article 120 Transitional provisions Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void at the … Read more
how this may (not) work for you Elevator pitch The new amendment to the MDR is nicknamed the ‘MDR Extension Regulation’. This has some truth in it, but it does not cover the whole story. It may also create incorrect expectations with stakeholders. So here is the one-sentence elevator pitch I would recommend preparing, in … Read more
Expiring certificate At this moment AIMDD or MDD certificates may expire before a new MDR certificate is issued. In that case, a manufacturer may lose access to the EU market. MDCG 2022-18 provides guidance about how the Competent Authorities will handle the specific situation when a non-conformity is created by the expiration of a certificate … Read more
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