Change evaluation

Reacting to the pressure from industry, hospitals and medicine the commission adapted and extended the transition period between MDD and MDR. Manufacturers now have more time to implement new or expanded MDR requirements into the technical documentation of their existing products. Meanwhile, reliable products are still available on the market. However, products cannot be frozen on a technical level indefinitely. Changes of materials or suppliers, adjustments to product descriptions or instructions for use are not the only possible alterations and 2028 is often too far away to postpone these alterations.
This begs the questions of how a changed product is covered by the extended MDD certificate.

We apply the requirements of the change evaluation to your products and discuss how/if planned changes have an influence on the validity of the original MDD certificate.

Our services regarding change evaluation include:

• Transfer of knowledge: We illustrate which criteria come into effect for the change evaluation in a workshop format.
• Document creation: Together with you we develop the change evaluation and make a well-founded statement regarding the feasibility in the context of the existing MDD-certificate.