EU adopted the Medical Device Regulation On April 5, 2017, replacing the two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive. The new regulation entered into force on 26 May 2021.

The transitional period originally scheduled for 26 May 2024 was extended to 31 December 2027 or 31 December 2028 depending on the risk class of the device (proposed amendment to Regulation (EU) 2017/745)

The new EU 2017/745, MDR Transition Timeline is as follows

• 31 December 2027: class III medical devices and class IIb implantable medical devices; except sutures, staples, dental fillings, orthodontic appliances, screws, wedges, plates, wires, pins, clips and connectors
• 26 May 2026 : Class III implantable custom-made devices
• 31 December 2028: class IIb devices (other than those mentioned above), IIa and I

Despite the extended time for completing the MDR transition, I3CGLOBAL strongly advises manufacturers who have already made or planned their MDR applications and documentation submissions with notified Bodies to adhere to their plans. Additionally, they strongly urge other manufacturers who have not yet submitted their MDR applications to do so promptly for the following reasons:

• Only those devices transitioning to the MDR benefit from the longer transition timelines and extended MDR Certificate validity
• Delaying or changing your current planned technical file submission will lead to the risk of NB application acceptance due to bandwidth for conformity assessment
• ​​​​​​Manufacturers are not allowed to make significant changes to the design or intended purpose of their devices under the Directives even under the longer transition timelines

Preparing Technical Documentation and undergoing assessment by a notified body is a laborious process involving the efforts of numerous qualified individuals. Consequently, the lead time is contingent on several factors, highlighting the importance of early planning for MDR technical documentation and NB application.