Article 61(10) within the EU MDR | Notified Body Insights & the Role of PMCF Surveys

Webcast

Jul 31

In this session, Breda Kearney, Clinical Regulatory Lead from BSI and Chris Webb, Research Manager and PMCF expert from Purdie Pascoe explore the correct application of Article 61(10) under the EU MDR and the critical role of PMCF surveys in supporting compliance.

Many manufacturers misapply Article 61(10), risking non-compliance. This session clarifies when and how it should be used, what documentation is still required, and how PMCF surveys can support your regulatory strategy—especially when pre-market data collection is not feasible or ethical.

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Lauren Poole

Article 61(10) within the EU MDR | Notified Body Insights & the Role of PMCF Surveys

In this session, Breda Kearney, Clinical Regulatory Lead from BSI and Chris Webb, Research Manager and PMCF expert from Purdie Pascoe explore the correct application of Article 61(10) under the EU MDR and the critical role of PMCF surveys in supporting compliance.

Complete the form below to watch the webcast:

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