The European Commission has Amended the Regulation (EU) 2017/745 on medical devices MDR and regulation (EU) 2017/746 on in Vitro Medical Devices IVDR, due to the existing limitations in the number and capabilities of notified bodies. These constraints have resulted in certification bottlenecks, particularly during the transitional period.
Changes in Regulation (EU) 2017/745:
Specifically Article 44, regarding the reassessment of notified bodies:
The timing of the first complete reassessment of a notified body after notification has been deferred to 5 years after notification instead of the original 3 years. The frequency of subsequent complete reassessments has also been changed to every 5 years. The authority responsible for notified bodies can conduct a reassessment earlier than the normal cycle if justified by the results of the annual assessment activities of the notified body or upon the request of the notified body. Complete reassessments that have already started should continue, but the authority responsible for notified bodies may suspend or terminate them, taking into account the resources already spent on the reassessment and the results of the annual assessments.
Changes in Regulation (EU) 2017/746:
Article 40 of the regulation currently requires a complete reassessment of notified bodies three years after notification, and every fourth year thereafter.
The timing of the first reassessment of notified bodies should be deferred to five years after notification.
Subsequent reassessments should also be changed to every five years, and the authority responsible for notified bodies may conduct earlier reassessments based on results of annual assessments or at the request of the notified body.
Complete reassessments that have already started should continue, unless the authority responsible for notified bodies decides to suspend or terminate them, taking into account resources already spent and results of annual assessments.
Key Points:
The amendment changes the timing of the first reassessment of notified bodies after notification from three years to five years, and subsequent reassessments should also be conducted every five years.
The authority responsible for notified bodies may conduct earlier reassessments if justified by results of annual assessments or requested by the notified body.
Complete reassessments that have already started should continue, unless the authority responsible for notified bodies decides to suspend or terminate them, taking into account resources already spent and results of annual assessments.
This Regulation enters into force as a matter of urgency to enhance the capacities of notified bodies in the interest of public health.