27 November 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.
For MDR and IVDR devices on Quality Management System (QMS) certificates (Annex IX, Chapter I and III) there is a requirement that the manufacturer must inform their Notified Body (BSI) of plans to make substantial changes to their quality system or product range covered.
For MDR and IVDR devices on a product certificate (Annex IX, Chapter II) the manufacturer is required to inform BSI of any changes to the approved device, where such changes could affect the safety and performance of the device, or the conditions prescribed for use of the device. Approval must be obtained from the Notified Body prior to the implementation of such changes.
For devices listed on QMS Certificates (Annex IX, Chapter I and III) any changes to PMCF/PMPF plans will be subject to review during any future technical documentation assessments and QMS audits.
In the context of PMCF/PMPF plans for both MDR and IVDR devices on product certificates, (Annex IX Chapter II), BSI expects that substantial changes are notified to BSI for assessment prior to their implementation. This is to ensure that the changes made to the PMCF or PMPF plans are both applicable and valid to address the unanswered questions of the original clinical/performance evaluation assessment performed by the notified body. Non-substantial changes need not be notified separately, but will be subject to future technical documentation assessments, recertification 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
