Module 18 2021

Classification

If it is a Medical Device..

• Is it an IVD, MD or AIMD?

• How long is it intended to be used for? • Is it invasive? • Is it implantable? • Is it ‘active’? • How does it work? (physically?) • Does a ‘special’ rule apply?

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Other Factors influencing classification

- Does the Device contain a medicinal substance? - Does the Device contain animal derived tissue? - Does the Device contain tissue derived from TSE susceptible species? - Does the Device contain a human blood derivative?

Classification rules : General medical devices (Part II): Regulation 7 and Annex IX

IVD (Part IV): Regulation 40 and Annex II AIMD (Part III): All the same class – Class III

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