MHRA Decision Aid: MDR Extended Transitional Period Coverage Assessment
This decision aid flowchart has been designed to aid manufacturers and relevant stakeholders in determining the applicability of the extended transitional period outlined in Article 120 of Regulation (EU) 2017/745 on medical devices (MDR), as modified by Regulation 2023/607. The flowchart is a valuable tool for assessing whether a specific device qualifies for the extended transitional period and offers insights into eligibility, conditions, and deadlines concerning the market entry or deployment of certain devices in alignment with Article 120 MDR. While utilizing the flowchart, it's recommended that users consult the MDR text, which holds precedence over this tool, as well as the Q&A section addressing practical facets of implementing Regulation (EU) 2023/607.
Extended Transitional Period
The Extended Transitional Period refers to a specific timeframe during which certain medical devices are allowed to continue being placed on the market and put into service under the regulatory requirements of the previous regulations, even after new regulations have been introduced. This period is established to provide manufacturers, regulatory authorities, and other stakeholders with additional time to adjust to the new regulatory framework and ensure a smooth transition.
The flowchart is segmented into two main sections:
Part 1: Legacy Devices under Article 120(3a) MDR
This section covers devices that fall into two subcategories:
Devices that were encompassed by a certificate issued by a notified body following the stipulations of Directive 90/385/EEC (AIMDD) or Directive 93/42/EEC (MDD) prior to 26 May 2021.
Devices that were considered "legacy devices" as per Article 120(3b) MDR:
This refers to devices subject to the conformity assessment procedure according to Directive 93/42/EEC (MDD) that didn't necessitate the participation of a notified body.
The declaration of conformity for these devices was prepared before 26 May 2021.
Furthermore, the devices' conformity assessment procedure under the MDR mandates the engagement of a notified body.
Part 2: Class III Custom-Made Implantable Devices under Article 120(3f) MDR
This part pertains to a specific category of devices:
It encompasses Class III custom-made implantable devices in accordance with Article 120(3f) MDR.
In conclusion, this decision aid flowchart serves as a guide for determining whether a device qualifies for the extended transitional period outlined in Article 120 MDR. It is a resourceful tool for manufacturers and relevant stakeholders to comprehend the intricate eligibility criteria, associated conditions, and pertinent deadlines concerning the introduction or utilization of specific medical devices as defined by the regulations. Nonetheless, users are advised to give due consideration to the authoritative MDR text and the provided Q&A for practical insights linked to the execution of Regulation (EU) 2023/607.