IVD Manufacturers, its time to get ready for IVDR
How can we leverage PMCF survey experience for IVDR submissions?
By Marcus Torr, PMCF/PMPF Lead
EU-MDR & EU-IVDR
Both the EU Medical Device Regulation (EU MDR) and the EU In-Vitro Diagnostics Regulation (IVDR) are new and updated sets of regulations, following on from the Medical Device Directive (MDD) and the In-Vitro Diagnostics Directive (IVDD) respectively. The EU-MDR comes into force in May 2021, while the IVDR follows a year later in May 2022.
Not only are there similarities in the naming of the regulations, but they both also share extensive commonalities in their guidance and documentation. In this article, we will aim to highlight these similarities, particularly surrounding Post Market Surveillance (PMS) and its data collection, building upon learnings taken from the EU-MDR process that can be applied for the IVDR.
Key similarities
MDR:
IVDR:
Article 83 of the MDR and Article 78 of the IVDR set out the requirements for PMS. PMCF (for devices) is covered in Annex XIV Part B of the MDR and PMPF (for IVDs) in Annex XIII Part B of the IVDR. Both PMCF and PMPF are addressed within the PMCF/PMPF plan, which in turn is part of the Post Market Surveillance (PMS) plan. They are both described as a continuous process that updates the clinical/performance evaluation and can be used to provide additional evidence to that previously collected.
How can PMCF experience help with your PMPF approach?
In simple terms, PMCF and PMPF outline how the manufacturer will proactively collect and evaluate the clinical and performance data related to their CE-marked device/diagnostic. The objectives are to:
Confirm the safety and performance of the device/diagnostic throughout its expected lifetime.
Identify previously unknown risks or limits to performance and contraindications.
Identify and analyse emergent risks on the basis of factual evidence.
Ensure the continued acceptability of the clinical evidence and of the benefit-risk ratio.
Identify possible systematic misuse or off-label use
As stated in Article 78, the post-market surveillance system shall be suited to actively and systemically gathering, recording and analysing relevant data of the quality, performance and safety of a device throughout its entire lifetime
With May 2022 fast approaching, it is time for IVD manufacturers to look closely at their PMPF planning. We can leverage our experience with the earlier implementation of EU-MDR, for which PMCF data collection has been underway for the last two years as manufacturers ready for the May 2021 deadline. PMCF data has been collected via multiple routes, from literature reviews, and user surveys, through to clinical studies and there is no reason why PMPF data collection cannot follow suit.
When weighing which approach(es) to take, it is vital that the balance between the level of evidence required and the time and effort to collect this evidence is considered. While clinical studies provide a higher level of evidence, they are often time consuming and expensive; end-user surveys, on the other hand, provide slightly lesser evidence but are much lower effort, cost-effective and have a much quicker turnaround.
The justification for end-user surveys will depend on the type of device/diagnostic, including the risk classification and previous data obtained. They can be used alongside other PMCF/PMPF methods to strengthen the evidence of data for all risk classes.
How can we help implement PMPF End-User Surveys?
Purdie Pascoe has conducted over 100 PMCF surveys over the last couple of years for several of the leading medical device manufacturers, aiding them with both the design and the execution of the surveys themselves. With this vast experience in PMCF surveys and the similarities between the two regulations, Purdie Pascoe can help assist with any upcoming PMPF planning and survey implementation.
With few Notified Bodies available, and a large number of IVDs to review (in addition to medical devices currently under review), it is key for IVD manufacturers to plan ahead of May 2022. Based on the classification under which your IVD falls, the PMPF will need to be updated at various frequencies. Most companion diagnostics will fall under Class C (and some under Class D), for which the Performance Evaluation Report (PER) that includes PMPF data will need to be updated at least once yearly.
At Purdie Pascoe, we can help with the survey process, from PMPF plan design through to reporting, taking the load from your shoulders, turning your IVDR PMPF plan into an online survey, managing the recruitment, collecting the data and turning this into visual and informative deliverables. Our approach is also compliant with both GDPR and data privacy regulations.
So make sure that you have everything in place to be compliant with the EU-IVDR, today.