On December 14, 2021, the European Commission adopted a new Implementing Regulation (EU) 2021/2226 for the use of electronic instructions for use (eIFUs) for medical devices. The Implementing Regulation applied on January 4, 2022, and adapts the conditions and requirements for manufacturers of medical devices, including software covered by the medical devices regulations, to go paper-free.
The use of eIFUs for medical devices is now common practice, and the benefits are obvious: E-labeling produces less paper waste and reduces costs and logistical challenges to provide each product with the correct IFU in the current version and the desired language.
IFUs are crucial to ensure medical device safety by giving users access to important information when needed. Therefore, the Implementing Regulation aims to ensure that the level of safety for eIFU is at least as high as for paper-based IFUs.
The Implementing Regulation applies to devices placed on the market under the Medical Devices Regulation (MDR) and repeals and replaces Commission Regulation (EU) 207/2012, which has allowed the use of eIFUs since 2013. The Implementing Regulation sets out the conditions under which eIFUs may be provided and the requirements concerning contents of and websites for eIFUs.
Below are some of the key points of the Implementing Regulation:
- The Implementing Regulation expands the use of eIFUs to a larger group of medical devices — in particular to all software falling within the scope of the MDR — and when it is not exclusively intended for professional users but for patients (e.g., apps).
- Manufacturers must take into account two new elements when performing the required risk assessment: (1) the assessment of the eIFU’s compatibility with different devices that could be used to display the instructions and (2) the management of different versions of the eIFU, where applicable.
- As the Implementing Regulation requires that websites containing IFUs should fulfill the transparency requirements under the EU General Data Protection Regulation (GDPR), consent being obtained for the processing of the personal data needs to be GDPR-compliant (including as it relates to the use of any nonessential cookies on the website).
Note that the previous rules, set out in the Commission Regulation (EU) 207/2012, still apply for devices that are placed on the market in accordance with Article 120(3) of the MDR.
Manufacturers that want to continue using eIFUs or consider switching to eIFU under the MDR framework should carefully review the new Implementing Regulation and examine how their current procedures comply with the new requirements.
 A prior Sidley Insight alert of May 19, 2021, also reviewed the proposed Implementing Regulation; read here: Digitalization Instructions for Use EU Issues Updated Framework for eIFUs of Medical Devices.
Sidley Austin LLP provides this information as a service to clients and other friends for educational purposes only. It should not be construed or relied on as legal advice or to create a lawyer-client relationship. Readers should not act upon this information without seeking advice from professional advisers.
Attorney Advertising—Sidley Austin LLP, One South Dearborn, Chicago, IL 60603. +1 312 853 7000. Sidley and Sidley Austin refer to Sidley Austin LLP and affiliated partnerships, as explained at www.sidley.com/disclaimer.
© Sidley Austin LLP