Smridula Hariharan

Ask the Expert: PMCF implementation under EU MDR

By MTI Marketing Staff
Smridula Hariharan

Smridula Hariharan leads a team of medical writers who work on CEPs, CERs, PMS Plan, Post-Market Surveillance Reports, Periodic Safety Update Reports, Post-Market Clinical Follow-up Plan and Reports, for devices spanning a wide range of therapeutic areas. Here, she shares secrets to cost-effective PMCF strategies in the dynamic landscape of the European Medical Device Regulation (MDR).

MTI Ask the Expert

In a recent webinar titled Strategies for Successful PMCF under EU MDR: Unlocking the Mystery, medical device industry experts Smridula Hariharan and Parvathi Nambiar engaged in an illuminating discussion. They explored cost-effective PMCF strategies, discussed how to adeptly address Notified Body comments, and presented real-world case studies to illustrate successful PMCF implementations.

Following the presentation, MTI asked Smridula Hariharan, Manager, Medical Device Services at Celegence to answer a few additional questions from attendees. 

Featured Expert: Smridula Hariharan, Senior Manager Regulatory Services, MDR/IVDR, Celegence

Can we submit interim safety (and, potentially performance) data to NB with PMCF commitment that goes out to the functional or expected lifetime of the device?

Smridula: Yes, provided the PMCF is being maintained to establish safety/performance throughout lifetime and is not being done to fill gaps in clinical data. If it is to address gaps in clinical data, it will have to be completed within a fixed timeframe/specific sample size. 

Can you use data from a clinical investigation for a new indication for the PMCF/Clinical Evaluation for the approved indications?

Smridula: If the collected data has data on already approved indications for which the PMCF is necessary, then yes. 

Could you utilize these PMCF strategies for PMPF for IVDs?

Smridula: Most of the strategies listed here are applicable to IVDS as well. Data from public safety databases for IVDs is limited or unavailable, but the rest of the strategies would be applicable. The setting of the surveys/registries would be tuned to IVDs (labs rather than hospitals) but the basic essence or principals would remain the same.

Do you have any recommendation for systematic collection of data regarding off-label use outside of pre-market clinical investigation pathway? 

Smridula: Surveys, especially targeting healthcare providers charged with prescribing/administering the device. 

For a Class IIb legacy device with direct benefit that does not have enough clinical evidence, does a PMCF survey strategy suffice, or is a clinical study required? 

Smridula: A survey could suffice as long as it is well planned and focused on the outcomes of interest. A low quality survey focusing on multiple datasets to be recollected or data on ease of use, etc. would not be considered sufficient. 

How is clinical data of similar devices reviewed and taken into consideration? Only via literature review? 

Smridula: published literature, examination of freely available IFUs/technical information available on the similar devices, data from the public safety databases, data from public clinical trial databases. 

Have you used Truveta and Datavant to acquire RWD?

Smridula: So far no, but if there is sufficient data related to the outcomes of interest captured on the EHRs, then yes, they can be successfully leveraged as a source of RWD. 

You noted that one of the circumstances requiring PMCF clinical investigations is “new indication or claim.” According to MDR, PMCF are for CE devices placed in the market WITHIN its intended purpose. Is this contradictory? How can this only apply where there is already a clinical evidence captured in a CER? Similarly, if I list a claim/clinical benefit on my marketing brochure but there are no literature papers to back this up, can I use positive PMCF surveys to back up my claim/clinical benefit, which shows that patients do see a positive effect? 

Smridula: Anything already on your marketing documents needs to have data available to support it, it need not all be good quality/measurable but something has to be available. If they currently do not have ANY data at all and you intend to collect all data from the PMCF, they should not be in the marketing documents. Once proof is collected and evaluated, they can go back into the marketing documents. 

PMCF cannot be used for a new indication, but can be used for a new claim. For instance, in a device that “provides shock converting ventricular fibrillation to sinus rhythm,” this is an existing claim/indication. If I now claim it does this better than available technologies in the market, the performance objective for conversion is higher. There is no new indication but the claim is new. To support this claim I can use PMCF provided as there is already clinical data to show that my device does, in fact, convert Vfib to sinus rhythm. 

If you find an off-label usage in PMCF, would it be easy to use the obtained data to certify the specific usage?

Smridula: yes the data can be leveraged

Once you have gathered data on residual risks that prompted specific PMCF, can you then revert to general PMCF methods? 

Smridula: Yes

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