On 14 December 2021, the European Commission published a new Implementing Regulation, (EU) 2021/2226, explaining the rules regarding the application of the Medical Device Regulation (MDR). Specifically, this document highlights the provision of electronic instructions for use (eIFU) for medical devices, which came into force on 4 January 2022.
As detailed in Article 10 of (EU) 2021/2226:
- Devices placed on the market under the MDR should comply with this new regulation, which replaces regulation (EU) 207/2012.
- For devices placed on the market under Article 120(3), ‘transitional provisions’ of the MDR, (EU) 207/2012 remains applicable until 26 May 2024.
The EU Commission reiterated the benefits of providing eIFUs for certain devices, which include reducing environmental burdens and costs. However, the requirement to maintain or improve the level of safety remains.
When comparing the new regulation, (EU) 2021/2226 with (EU) 207/2012, there are many common elements that are identified within ‘correlation table’ provided as an Annex of
(EU) 2021/2226.
The proceeding section outlines notable changes introduced by (EU) 2021/2226:
Article 3 of both regulations provides a list of devices that may be supplied with eIFUs rather than paper IFUs. Aside various formatting changes, including consistent reference to ‘devices covered under the MDR’, the devices within scope are unchanged and are comprised of:
- Implantable and active implantable medical devices and their accessories
- Fixed installed medical devices and their accessories
- Medical devices and accessories fitted with a built-in system to visually display the IFU
A new subsection, Article 3(3), includes software covered by the MDR and replaces ‘stand-alone software covered by Directive 93/42/EEC’. Article 3(2) pertaining to conditions under which eIFUs can be provided for the aforementioned devices are unchanged, including that ‘devices and accessories are intended for exclusive use by professional users’.
Article 4 covering the requirement for manufacturers to undertake a documented risk assessment if an eIFU has been expanded slightly includes two additional requirements:
- ‘Assessment of the website’s compatibility displaying the electronic instructions for use with different devices which could be used to display those instructions’
- ‘Management of different versions of the instructions for use, where applicable in accordance with Article 5(8)’
Article 5 describes the conditions that must be met for manufacturers to provide an eIFU. There is one notable amendment and three additions within the new regulation.
Article 5(9) has been amended to include an additional requirement that the eIFU shall be made available ‘for 10 years after the last device has been placed on the market’. Three new subsections of Article 5, 11-13 address various procedural aspects for manufacturers maintaining eIFUs on their websites, including language requirements, alerting device users to updates or corrective actions to eIFUs and availability of historical versions of eIFUs.
It remains to be seen if the previous MDD regulation requirement for implantable device manufacturers (without a defined expiry date) to ensure that eIFUs are available for 15 years after the last device has been placed will continue.
Article 6 has attracted a number of minor amendments including reference to software (6(1)), the requirement to include Basic UDI-DI and/or UDI-DI to allow identification of the device, and examples of what constitutes the manufacturers contact details (6(3)).
By virtue of additions made to preceding articles, including language requirements – Article 5(11), Article 7 has been amended accordingly. Furthermore, the current regulation covering processing of personal data, (EU) 2016/679 is included in Article 7(2(d)).
Article 8 has been simplified, with reference to Class I devices removed and reads, ‘Where applicable, the fulfilment of the obligations laid down in Articles 4-7 of this Regulation shall be reviewed by a notified body during the procedure applicable for conformity assessment as referred to in Article 52 of Regulation (EU) 2017/745’.
In conclusion, the new Implementing Regulation, (EU) 2021/2226, builds on the requirements covered in the previous regulation provided under the MDD. It provides manufacturers with important information regarding the provision of eIFUs for their devices under the MDR. Manufacturers should review this new regulation to ensure that their procedures reflect the associated requirements.
How Can NAMSA Help?
- Do you have devices that utilize eIFUs, or should you be providing users with eIFUs?
- Do you host IFUs for your devices on your website?
- Are you unsure of the impact of Implementing Regulation, (EU) 2021/2226 on your organization’s medical device products?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of medical device and IVD development experts communicate with EU entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for manufacturers. In fact, many of our Associates have previously held positions within these organizations, which provides Clients the benefit of a clearer understanding on how to proactively plan for international requirements and expectations.
To learn about NAMSA’s full suite of Regulatory and Quality services and solutions, including MDR compliance planning, please visit: https://namsa.com/services/regulatory-and-quality-consulting/ .
We also invite you to access our complimentary MDR and IVDR Planning Resources, here.
David Mandley, PhD
David joined the Regulatory Consulting Team at NAMSA in 2021 and currently serves as a Principal Regulatory Consultant. Mr. Mandley has more than 20 years’ experience in the medical device industry working with a range of product types and organisations from university spin-outs to multinationals. Following completion of his doctoral research in Applied Photochemistry at Loughborough University, David held various roles for a UK-based SME, Tissuemed, including Research & Development, QA, RA—culminating into serving as CEO for eight years. During this period, David was pivotal in the development, regulatory approval and commercialisation of a range of implantable, resorbable surgical sealants indicated as adjuncts for the prevention of intra- and post-operative leaks, including air, blood and cerebral spinal fluid. More recently, Mr. Mandley has worked as a regulatory consultant for a range of multinational medical device manufacturers, leading MDR submissions for a variety of device types and classifications (I – III) from wound care devices and their accessories, combination products and radiofrequency ablation systems.