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 23 and 30 April 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 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
PRRC Academy Welcome in the PRRC Academy, the home of the Training Services of Boumans Regulatory Consulting. PRRC announcements New trainings curriculum for 2024 2022, November 26 Our curriculum Our courses PRRC Academy 2024 02-19 & 26 | In-house manufacturer PRRC starter training PRRC Academy 2024 03-05 & 12 | In-house authorized representative PRRC training … Read more
Privacy policy Boumans Regulatory Consulting is responsible for the processing of personal data as reflected in this privacy statement. Stadserf 114, 3112 DX Schiedam NL +31 6 3928 0403 ronald@boumansconsulting.com Chamber of Commerce 86140671 Personal data that we process Boumans Regulatory Consulting processes your personal data because you use our services and/or because you provide … Read more
Your free document Freebie 1 €0 Remove Personal info Email address * We will send the purchase receipt to this address. First name * We will use this to personalize your account experience. Last name * We will use this as well to personalize your account experience. Your organisation* Number of employees Optional Your role … Read more
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