After the European Commission published Implementing Regulation (EU) 2021/2226, a new era began for manufacturers of implantable medical devices. But what is expected from manufacturers to comply with this regulation?
Regulation 2021/2226 highlights
The regulation specifies which medical devices can use e-IFU as the sole IFU – meaning no paper IFU is required. Article 3 specifies that implantable and active implantable medical devices and their accessories are covered, but only if devices are used by professionals and use by other persons is not reasonably foreseeable.
Medical device regulation (EU) 2017/745 highlights
The MDR provides detailed definitions including 'instructions for use', 'implantable device', 'active device', and accessories. For many manufacturers, the definition of 'accessory for a medical device' causes confusion. Not every instrument used during surgery is automatically an accessory – it must enable or assist the device in its intended purpose.
Conclusion
Even though the regulation is clear, it is not always clear for manufacturers if their device meets the definitions. Making sure the device meets the correct definition is the first step. The second step is to rationalise the exemption for having a mandatory paper IFU.
