In the ever-evolving landscape of medical device regulations, it's crucial for manufacturers and stakeholders to stay updated and informed. Regulation (EU) 2017/745 on medical devices (MDR) has been subject to various amendments, and one of the significant changes comes in the form of Regulation 2023/607. To assist manufacturers and other relevant parties in deciphering the implications of these amendments, a valuable tool has been introduced - the MDR Flowchart.

This flowchart serves as a guiding light for those seeking to understand the extended transitional period provided by Article 120 of MDR, as amended by Regulation 2023/607. Its primary purpose is to help determine the eligibility, conditions, and deadlines for placing certain medical devices on the market or putting them into service. However, it's essential to remember that the flowchart is a supplementary tool and should be used in conjunction with the MDR text and the Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607.

A Two-Part Journey

The MDR Flowchart is thoughtfully divided into two distinct parts, each addressing specific categories of medical devices.

Part 1: Legacy Devices (Article 120(3a) and 120(3b) MDR)

This segment of the flowchart is dedicated to devices falling under Article 120(3a) and Article 120(3b) of MDR. Let's delve into these categories:

Article 120(3a) MDR: Refers to "legacy devices" covered by a certificate issued by a notified body in accordance with Directive 90/385/EEC (AIMDD) or Directive 93/42/EEC (MDD) prior to 26 May 2021. If your device falls into this category, the flowchart will guide you through the steps necessary to understand your device's status and any actions you may need to take.

Article 120(3b) MDR: Addresses "legacy devices" for which the conformity assessment procedure pursuant to Directive 93/42/EEC (MDD) did not require the involvement of a notified body. These devices should have had their declaration of conformity drawn up before 26 May 2021. If your device fits this description, and the conformity assessment procedure pursuant to the MDR now requires the involvement of a notified body, the flowchart will help you navigate the transition process smoothly.

Part 2: Class III Custom-Made Implantable Devices (Article 120(3f) MDR)

The second part of the flowchart focuses on a specific subset of medical devices - Class III custom-made implantable devices as defined in Article 120(3f) of MDR. These devices hold a distinct position in the regulatory landscape due to their unique characteristics. If your product belongs to this category, the flowchart will provide tailored guidance to ensure compliance and a smooth transition into the new regulatory framework.

A Valuable Resource

In conclusion, the MDR Flowchart is an indispensable resource for manufacturers and stakeholders in the medical device industry. It offers clarity and direction in navigating the complex web of regulations, ensuring that your devices meet the necessary criteria and deadlines for placement on the market or putting into service. Remember to use the flowchart in conjunction with the MDR text and the Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 to ensure complete compliance with the latest regulations.

As the medical device landscape continues to evolve, staying informed and utilizing tools like the MDR Flowchart will be key to success in this highly regulated industry. Embrace the guidance it provides, and chart a course to compliance and continued innovation in the field of medical devices.