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 4 and 11 March 2025 at 16:00 – 18:00 CET (Amsterdam time) Who should participate This training … Read more
Be consistent, stay consistent With increased market surveillance focusing on the compliance and quality of authorized representatives, it’s crucial to be well-prepared. Recently, a survey conducted by the Dutch competent authority revealed issues with every sampled authorized representative. A significant number lacked a proper mandate, while the majority failed to effectively manage client compliance. Similar … Read more
A PRRC with experience You can study the theory for every job, and this should be part of your preparation, but the theory will not provide you with experience. Becoming an experienced PRRC means that you have to learn from mistakes. But that doesn’t mean that you have to make these mistakes yourself. You can … 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
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 March 2024 at 16:00 – 18:00 CET (Amsterdam time) Who should participate This training is for … 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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