A factsheet for manufacturers released by the European Commission (EC) outlines the regulation of Class I medical devices following the implementation of the European Union (EU) Medical Device Regulation (MDR).
In emphasising the importance of the new requirements for Class I devices under the MDR, the factsheet also notes the importance of the new classification rules being introduced. Consequently, manufacturers must determine whether their existing Class I devices have been upgraded to a higher classification.
A step-by-step approach to ensuring Class I medical device compliance is detailed in the factsheet:
- The applicable provisions of the MDR should be integrate into the manufacturer’s Quality Management System (QMS)
- It should be established that the product qualifies as a medical device in line with its intended purpose
- It should be established that the device is a Class I medical device in line with the MDR (Annex VIII)
- All applicable general safety and performance requirements must be met (Annex I) along with the inclusion of technical documentation (annexes II and III).
- The manufacturer must demonstrate compliance with the general obligations (Article 10)
- An EU declaration of conformity must be created by the manufacturer in line with Annex IV
- As per Annex V, the device should bear a CE mark
- Both the device and the manufacturer must be registered in Eudamed
- The manufacturer must conform to all necessary post market activities (e.g. post market surveillance, reporting of incidents and field safety corrective actions).
The factsheet ends with a brief FAQ section. It includes information on timelines, stating that the transition period in which Class I devices that will require the involvement of a notified body for the first time under the MDR can be placed on the market lasts until May 2024. Distributors can make available on the market, and end-users can put into service such devices until May 2025. All other Class I devices that remain in the same class under the MDR must comply with MDR requirements from the implementation date of 26 May 2021.
Further questions detail the instructions for use and their language requirements, along with the regulatory statuses of parts, accessories and components of Class I medical devices (some of which can be classified as devices in themselves).
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