Essentials of European Medical Device Regulatory Affairs - June 2020

Clinical Evaluation

CER needs to be updated based on • Information from PMCF • Post market surveillance plan

The PMCF evaluation report and summary of safety and clinical safety and clinical performance (article 32) for Class III and implantable devices needs to be updated annually.

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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)

TheOrganisation for Professionals in Regulatory Affairs

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