The basic principle for carrying out conformity assessment procedures remains the same. However, under the MDR, the following products are now subject to a dual safety mechanism:
Implantable Class III products
Active Class IIb products intended to administer and/or remove medicinal products, body liquids or other substances to or from the body to which common specifications do not apply or if this is the first certification for such a product.
The dual safety mechanism consists of:
Pre-market clinical consultation procedure
Post-market control of the conformity assessments (scrutiny procedure)