Essentials of European Medical Device Regulatory Affairs

Clinical Investigations Article 62

• Need a legal representative in the EU if sponsor is from outside the EU • if trial in a single EU country the member state may allow a local contact • Ethics review is required (per national requirements) • A trial can start once the CA and ethics approval is obtained • Vulnerable populations are protected • The benefits of the CI justify the risks • Consent is obtained (special pops see articles 63-68) • Personal data is protected • Study as pain free and comfortable as possible • Conducted by a medical doctor/dentist, qualified staff and in suitable facilities • No undue pressure (including financial) to take part • The device conforms to Annex I except the end points in the CI • Annex XV needs to be followed (protocols etc) • If a patient withdraws the information can still be used • Compensation /insurance per national law (article 69)

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Applications for CIs

Non CE marked devices (article 70)

and

CE marked devices outside of scope of intended purpose (article 74)

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