eIFU Requirements Under the MDR 

The Medical Device Regulation (MDR) introduces a comprehensive framework that integrates multiple electronic instructions for use (eIFU) requirements, further supplemented by Implementing Regulation (EU) 2021/2226, the successor to Commission Regulation (EU) 207/2012. In the realm of EU medical device regulation, the provision of eIFUs has been a longstanding requirement. Commission Regulation (EU) 207/2012 laid the foundation for these requirements over a decade ago. However, with the advent of the MDR, the landscape has evolved significantly. In this article, we delve into essential considerations surrounding eIFU requirements for both devices CE marked under the MDR and legacy devices, providing expert insights into navigating this complex regulatory terrain.

eIFU Requirements for Legacy Devices Under MDR

According to Medical Device Coordination Group (MDCG) guidance, legacy devices refer to those devices that, as per the transitional provisions outlined in Article 120 of the MDR, enter the market following the MDR’s date of application until the relevant deadlines based on classification, as specified in Article 120. GSPR 23.1(f) stipulates that the provision of an eIFU is permissible only to the extent and under the conditions outlined in Regulation (EU) 207/2012 or any subsequent implementing regulations introduced under the MDR.

Upon the release of Implementing Regulation (EU) 2021/2226 and the subsequent repeal of Regulation (EU) 207/2012 in December 2021, numerous manufacturers erroneously assumed that adherence to Regulation (EU) 207/2012 would become obsolete for legacy devices entering the market. This misconception stemmed, in part, from the extension of conformity deadlines for legacy devices under the MDR. However, Article 10 of Implementing Regulation (EU) 2021/2226 clarifies that Regulation (EU) 207/2012 remains applicable to devices placed on the market or put into service in accordance with Article 120(3) of the MDR, up until May 26, 2024.

Hence, irrespective of any deadline extensions outlined in Article 120(3) of the MDR beyond May 26, 2024, it is imperative for manufacturers of legacy devices providing eIFUs to ensure full compliance with Implementing Regulation (EU) 2021/2226 effective from this pivotal date.

Applicability of eIFU Requirements under MDR

A prevalent misconception among manufacturers concerning Regulation (EU) 207/2012 and Implementing Regulation (EU) 2021/2226 is the belief that these regulations solely pertain to cases where device instructions for use (IFUs) are exclusively provided in electronic format (eIFUs).

However, Article 9 of both regulations stipulates that if the eIFU is offered alongside a complete IFU in paper format, it must align in content with their paper counterparts. Moreover, if the eIFU is accessible through a website, the website must meet specific requirements as outlined in the regulations.

Therefore, manufacturers of devices offering both paper-based IFUs and eIFUs accessible via a website must ensure that the respective websites adhere to the outlined requirements.

Although GSPR 23.4.1(y) mandates the inclusion of the issue date of the IFU or, if revised, the date along with the identifier of the latest revision, it’s crucial to highlight that the regulations specified demand the availability of both previous versions and their respective publication dates on the website. Hence, compliance with GSPR 23.4.1(y) does not automatically ensure conformity with this additional requirement under the mentioned regulations.

Compliance Beyond eIFUs

Directive 95/46/EC was replaced by the General Data Protection Regulation (GDPR) (Regulation (EU) 2016/679) on May 25, 2018. It’s imperative for manufacturers, whether dealing with legacy devices or those CE marked under the MDR, to guarantee GDPR compliance for their websites. This entails particular attention to aspects such as the organization’s privacy policy and the handling of cookies.

Learn More About eIFU Requirements Under the MDR with MedEnvoy

In this article, we have provided a brief overview of eIFU requirements for both devices CE marked under the MDR and legacy devices. However, should you have any inquiries regarding labeling or require specialized training or consulting services, please don’t hesitate to reach out to us. We’re here to assist you further.

MedEnvoy’s regulatory experts can help manufacturers in staying compliant with the latest requirements including assistance with eIFU requirements for both devices CE marked under the MDR and legacy devices.

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