Changes to Exemptions for Well-Established Technological Devices Information and Training

This training comprehensively addresses the recent changes made by Delegated Regulations (EU) 2026/1451 and (EU) 2026/1359 to the exemptions applicable to certain implantable, Class III, and Class IIb devices under the Medical Devices Regulation (EU) 2017/745 (MDR).

The training program examines in detail the differences between the clinical evaluation and clinical investigation requirements under Article 61 of the MDR and the conformity assessment procedures under Article 52; the exemption approach for well-established and mature technologies; the device categories added to the exemption lists under the new regulations; and the impact of these changes on the processes of manufacturers and notified bodies.

Participants will learn about the changes introduced by (EU) 2026/1451 and (EU) 2026/1359 in a comparative manner, enabling them to assess which devices are eligible for which exemptions, the limits of these exemptions, and the current requirements that must be considered in clinical evaluation and technical documentation processes.

Training Topics

• Clinical Evaluation and Clinical Investigation Requirements Under the MDR
• Key Differences Between Exemptions Under MDR Articles 61 and 52
• The Exemption Approach for Well-Established and Mature Technologies
• Rationale and Evaluation Criteria for Expanding Exemption Lists
• Changes Under Delegated Regulation (EU) 2026/1451
• Clinical Trial Exemptions for Implantable and Class III Devices
• New Device Categories Added to the Exemption List by (EU) 2026/1451
• The Difference Between a Clinical Trial Exemption and a Clinical Evaluation Obligation
• Changes Under Delegated Regulation (EU) 2026/1359
• Exemptions from Technical Documentation Assessment for Class IIb Implantable Devices
• New Device Categories Added to the Exemption List Under (EU) 2026/1359
• Comparison of Regulations (EU) 2026/1451 and (EU) 2026/1359
• Impact of Exemptions on Manufacturer and Notified Body Processes
• Documentation and Implementation Requirements for Quality and Regulatory Teams

Who Is This Course For?

• Medical device manufacturers

• Professionals working at notified bodies
• Quality management system staff and managers
• Regulatory and compliance professionals
• Staff involved in clinical evaluation processes
• Experts involved in technical documentation preparation and evaluation processes
• Staff involved in product conformity assessment processes
• Professionals providing consulting services in the medical device sector
• Managers and experts responsible for implementing MDR requirements

What Will You Gain from This Training?

• You will learn about the latest changes to exemptions under the MDR as per (EU) 2026/1451 and (EU) 2026/1359.

• You will be able to correctly interpret the difference between the clinical investigation exemption and the clinical evaluation obligation.

• You will learn the current exemption approach regarding the technical documentation assessment for Class IIb implantable devices.
• You will understand the key criteria to consider when determining under which exemption a device can be assessed.
• You will be able to compare the newly added device categories and the differing scopes of the two exemption lists.
• You will be able to assess the impact of exemptions on manufacturers’ clinical evaluation and technical documentation processes.
• You will understand how changes should be taken into account in the conformity assessment and technical documentation review processes of notified bodies.
• You will learn the necessary approach for reviewing quality, regulatory, and product classification documentation in accordance with current regulations.