MDD (Medical Device Directive) and Medical Device Regulation (MDR) Transitional Provisions

If you have CE marked products in Europe, you may already be aware of the change from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR).  Currently, the MDD is no longer but if you have products that are CE marked under the MDD, Article 120 of the MDR may allow you to continue to place the CE mark (under the MDD) for a limited time. However, there are some restrictions e.g., one restriction is that you cannot make any significant design changes to the product.

This seems doable but changes will always come up. What if one of your components need to change due to obsolescence? What if one of your contract manufacturers can no longer supply parts to you? These changes may require a significant design change and you could be looking at transitioning into the MDR sooner than you may think.

The differences between MDR and MDD are significant and can be daunting. While MDD is about 60 pages long, MDR is much more comprehensive and is over 170 pages long and contains about a hundred more articles and annexes. Experts at Conformity Tech can help you with your transition from MDD to MDR.

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