Module 16 2022

9/2/2022

Interactive Case Study – Mobile Medical App

Device Description and Regulatory Status:

The Mobile Medical App is intended to detect, record, store and transfer electrocardiogram (ECG) rhythms from external contact sensors for vital sign monitoring. The Mobile Medical App displays ECG rhythms and output of ECG analysis on iOS and Android Smartphones.

• The medical SmartPhone App is a Class IIa SaMD • The from external contact sensors for vital sign monitoring are Class IIa devices. • The Medical SmartPhone App is offered for sale from Apples and Androids App Stores • The vital signs monitoring sensors are offered for sale from Amazon. • Current MDD:M5 CE-Mark Certificate expires in March 2023 • Involved EU Notified Body is not able to start an MDR Conformity Assessment in acc. with Annex IX prior November 2022 .

9/2/2022

The Organisation for Professionals in Regulatory Affairs

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Interactive Case Study – Mobile Medical App

• The medical SmartPhone App is a Class IIa SaMD • The from external contact sensors for vital sign monitoring are Class IIa devices. • The Medical SmartPhone App is offered from Apples and Androids App Stores

• The vital signs monitoring sensors are offered from Amazon. • Current MDD:M5 CE-Mark Certificate expires in March 2023 • Involved EU Notified Body is not able to start an MDR Conformity Assessment in acc. with Annex IX prior November 2022 .

Questions:

1) What should the legal manufacturer consider to commercially distribute the SaMD SmartPhone App and the vital signs sensors after 26 May 2021 in EU and EFTA States?

The legal manufacturer wants to continue commercial distribution of the SaMD SmartPhone App and the vital signs sensors post MDD:M5 CE- Mark certification expiry date.

2) What is a MDR compliant regulatory strategy ? 3) What MDR Regulatory Requirements do apply ? 4) What are the business risks and implications for the regulatory strategy?

9/2/2022

The Organisation for Professionals in Regulatory Affairs

48

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