MDD to MDR: The transition to (EU) 2017/745

The Medical Device Regulation (MDR, officially: (EU) 2017/745) replaces the Medical Device Directive (MDD) and has been legally binding since May 2021. Medical devices according to MDD that have not been converted accordingly may only be distributed until the expiry of the CE certification, i.e., five years after registration.

There has been set an extended transition period: end of 2027 (for higher risk products) and end of 2028 (for medium to low-risk products). However, this extension is subject to certain conditions.

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The MDR has some differences compared to the MDD. In general, the requirements are similar, but the MDR requires more detailed and concrete technical documentation. The following areas go beyond the requirements of the MDD:

• Reference to similar products and predecessor products
• Toxicology
• Biological materials
• Unique Device Identification (UDI)

We can assist you with the transition of existing products to the MDR or the registration of new products under the MDR. We have technical documentation experts in our consultancy portfolio to shorten the time to market for your products and eliminate potential rework.