Regulatory & More, Author at Regulatory and More

The Investigational Device Exemption (IDE)

Conformity Assessment Options for Products Failing under the MDR

Beyond the MDR and the IVDR: The WEEE Directive, the RoHS2 Directive, the REACH Regulation and other requirements

Trend Reporting under the MDR and IVDR (Art. 88/83)

Procedure for Dealing with Devices Presenting an Unacceptable Risk to Health and Safety under the MDR and the IVDR (Art. 95/90)

Evaluation of Devices Suspected of Presenting an Unacceptable Risk or other Non-Compliance under the MDR and the IVDR (Art. 94/89)

The Periodic Safety Update Report (PSUR) under the MDR and the IVDR (Art. 86/81)

The Person Responsible for Regulatory Compliance (PRRC) under the MDR and the IVDR (Art. 15/15)

The Field Safety Notices under the MDR and the IVDR (Art. 89(8)/84(8))

The Post-Market Surveillance (PMS) Plan under the MDR and the IVDR (Art. 84/79)