Module 18 2021

Guidance Documents

MHRA Guidance:

https://www.gov.uk/guidance/borderline-products-how- to-tell-if-your-product-is-a-medicine https://www.gov.uk/guidance/borderline-products-how- to-tell-if-your-product-is-a-medical-device https://www.gov.uk/government/publications/borderlines -between-medical-devices-and-medicinal-products https://www.gov.uk/government/publications/borderlines -with-medical-devices

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Guidance Documents

Classification:

• MEDDEV 2.4/1 - classification • MEDDEV 2.1/1 - definitions

• MEDDEV 2.1/5 – measuring function • MEDDEV 2.1/2 - Active Implantables

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