16 October 2024
There is currently a lack of guidance on what constitutes a substantial change to a PMCF / PMPF plan. To address this gap and to provide clarity for our clients, BSI has issued this communication setting out our expectations.
MDR (Annex IX Section 2.4 & Annex XI Section 6.4) and IVDR (Annex IX Section 2.4 & Annex XI Section 3.4) require the manufacturer to inform BSI of plans to make substantial changes to your quality system or product range covered. Such changes must be implemented only after review and approval by BSI.
MDR (Annex IX Section 4.10 and Annex X Section 5) and IVDR (Annex IX Section 4.11) requires you to inform BSI of any modification made to the approved device. Supplementary approval must be obtained for any modification affecting conformity with the general safety and performance requirements or conditions prescribed for the use of the device. Such changes must be implemented only after review and approval by BSI.
In the context of PMCF / PMPF plans, BSI expects that substantial changes are notified for assessment. Non-substantial changes need not be notified separately but will be subject to sampling during future technical documentation assessments and QMS audits.
Examples of substantial and non-substantial changes are listed below, however please note the list is not exhaustive.
What is considered a substantial change in the context of PMCF / PMPF?
• The need for conducting PMCF / PMPF has changed (e.g., PMCF / PMPF plans are changed in response to issues identified in the CER/PER, risk management, safety related concerns, etc.)
• Removal or ceasing of any ongoing or planned specific / proactive activities
• Delays or deviations (protocol, timelines, etc.) from the plan
• Changes to specific methods and procedures that could impact the overall quantity and quality of clinical data:
- Reduction in sample sizes, the number of sites or number of respondents
- Changes to objectives or endpoints
- Changes to statistical analysis plans
• PMCF / PMPF activities determined to be insufficient to fulfil the specific objectives set out.
What is a non-substantial change?
• Administrative changes to the PMCF / PMPF plan that impact legal manufacturer name, addresses, etc. that do not require further clinical evaluation.
• Changes to general methods such as screening of scientific literature, complaint trending, etc.
• New activities are added based on marketing interests, investigator-initiated studies, etc. which are supplemental and not meant to replace current activities. Please note that the adequacy of any such activities will be subject to assessment by the notified body during the next review (renewal, substantial / significant change notifications, technical documentation surveillance etc.).
How should the substantial changes to PMCF / PMPF plans be notified to BSI?
Manufacturers should notify their Scheme Manager of planned changes using the appropriate Notification Form (MDF4900) via the centralized mailbox: bsirsnotifications@bsigroup.com
Please be aware that it is not appropriate to notify BSI of substantial changes to the PMCF / PMPF plan solely within the PSUR document. The PSUR is a summary of all PMS data from a specific data collection period which is reviewed as a standalone document. The acceptability of a change to the PMCF / PMPF plan needs to be assessed in detail with supporting documentation (CEP, CER or PEP, PER etc.) and in a timely manner, and not subject to the delay which may arise linked to the submission schedule of the PSUR.
In cases where certification was granted contingent upon post-certification commitments (e.g., PMCF commitments including any interim PMCF reporting, etc.) failure to provide adequate documentation to meet such commitments within the agreed upon timescales may lead to certificate scope reduction, suspension or cancellation as appropriate.
Yours faithfully,
Richard Holborow Alex Laan
Head of Clinical Compliance Head of IVD, Notified Body
