European MDR Regulation

MDD 93/42/EEC refers to the Medical Device Directive which was the former regulatory requirement for medical devices in the EU. The Medical Devices Directive (MDD) set forth the safety and performance standards for medical devices being marketed within the EU. This directive was in effect for nearly 25 years until it was superseded by the new MDR regulation in the year 2017.

EU 2017/745, is the Medical Device Regulation that has taken the place of the MDD from 26th May 2022. This current framework enforces more rigorous regulations and criteria to guarantee the safety, quality, and efficacy of medical devices available in the European market.

The application timeline for the MDR Regulation to devices previously under the Medical Devices Directive (MDD) was extended from March 2023 to the end of 2027 or 2028, based on device classification. This extension aims to provide manufacturers, notified bodies, and stakeholders ample time to adapt to the new regulations. Additionally, it grants manufacturers additional time to ensure their devices meet the stricter requirements and complete the necessary conformity assessments.

The extension of the MDR aims to minimize disruptions in the availability of medical devices in the European market and to ensure a smooth transition from the previous regulatory framework (MDD) to the new one. It also allows a more phased and controlled implementation process, ensuring that all stakeholders are well-prepared and can meet the new obligations outlined in the MDR.

The extension is to ensure sure availability of CE-certified devices in the European market and facilitate a seamless shift from MDD to new MDR. It also enables a gradual and managed implementation, ensuring that all parties are adequately prepared to comply with MDR regulations and practices.

The current number of Notified Bodies under MDR is insufficient for manufacturers operating from Europe itself beyond the huge demand from foreign countries. Moreover, these notified bodies do not have the full technical scope of CE Certifying all types of devices. Considering the huge demand for recertification of MDD-certified products within transitional provisions end, not possible as anticipated. Acknowledging this issue, the EU Commission has identified the potential for a medical device shortage if manufacturers cannot migrate into MDR 2017/745.

Due to this reason, the EU Commission has extended the transition period from May 26, 2024, to December 31, 2026, for implantable Class III devices, December 31, 2027, for Class III and Class IIb implantable devices, and December 31, 2028, for all other devices.