What is the MDR? When did it come into force? Where exactly does the MDR apply and what are the Usability requirements for your medical device? How do you ensure that these Usability requirements are also compliant with the MDR?
In this basic terms article, you will find clear answers to these questions. We would like to give you a clear introduction to the topic, so that after reading you know what the MDR is and what it means for the Usability of your medical device.
What is the MDR?
The MDR is the European Medical Device Regulation. MDR stands for Medical Device Regulation. It was published under the name “Regulation (EU) 2017/745 on medical devices”. It regulates the requirements for medical devices in Europe. Its aim is to guarantee the best possible safety and high standards for medical devices. The regulation is relevant for manufacturers, distributors, but also for notified bodies, which are significantly involved in the clearance of the product.
The MDR came into force on May 25, 2017. The transition periods for the predecessor regulation MDD expired after four years on May 26, 2021. Since this date, the MDR is valid for all medical devices cleared in Europe.
For a few exceptions, there is a “grace period” until (at the latest) December 31, 2028 (however, only for already cleared products that have a certificate from a European notified body). For further information on the new grace periods check out our article about the “Extension of the MDR transition periods“.
You can find the complete regulation available on this link.
Why is the Medical Device Regulation so important for your product?
To place a medical device on the market in Europe, you must meet the requirements of the MDR.
Compared to the MDD, the entry into force of the Medical Device Regulation results in stricter and more detailed requirements for:
- The medical devices themselves and their safety
- The technical documentation of the manufacturing processes
- The quality management
- The classification of medical devices
- The marketing authorization
- The placing on the market
- The post market surveillance, i.e. the surveillance after the launch of a medical device on the market
Important! Even products that have already been cleared must be re-certified and thus adapted to the requirements of the Medical Device Regulation! However, only after the expiration of their certification period (source: MDR Article 120 (2)), but no later than May 27, 2024. Alternatively, you can of course decide to remove your product from the market then.
Usability Engineering is not explicitly mentioned by the MDR (but the word “Usability” appears twice), but should be done to comply with the essential safety and performance requirements of the regulation.
What are the Usability requirements of the Medical Device Regulation for your product?
The MDR requires you to exclude or best manage risks from use errors. Considering its intended purpose, the product must meet the general safety and performance requirements set out in Annex 1 of the MDR. (MDR Annex 1, paragraph 1)
These include:
- The safety of the patient, the user and any third parties during use must be ensured. (Annex I, Chapter 1, Paragraph 1).
- Foreseeable use errors must be identified, analyzed and minimized. (MDR Annex I, Chapter 1, paragraph 3 b, c and d)
- Risks due to the ergonomic features of the product must be minimized. (MDR Annex I, Chapter 1, paragraph 5 a)
- Consideration of the user’s skills, abilities, and physical requirements (or limitations) (MDR Annex I, Chapter 1, paragraph 5 b).
- Display and monitoring screens must be able to be interpreted quickly and without error in the relevant context of use. All indications and displays must be understandable to the user and, where appropriate, to the patient (MDR Annex I, Chapter 2, paragraph 21.3)
- The safe use of the product by lay persons (if they are a user group) (MDR Annex I, Chapter 2, paragraph 22).
- Any instructions and directions for use supplied with the product must also be clearly worded and demonstrably understandable to the intended users. (MDR Annex I, Chapter 3, paragraph 23)
You will find more information on those requirements and what they mean for you in our “Deep Dive: MDR and Usability” article.
How do you achieve the Usability requirements of the MDR for your product?
First and foremost, you should familiarize yourself with the processes and content of the Medical Device Regulation. For existing products, a gap analysis is recommended (i.e., asking, “What needs to be brought up to date?”).
The Medical Device Regulation requires the designation of a person responsible for regulatory compliance. This person should also be responsible for your efforts to ensure appropriate Usability of your product.
To meet the above Medical Device Regulation requirements for the Usability of your medical device, it is recommended to use the Usability Engineering process according to IEC 62366-1, which is not only recognized by the MDR, but also by the FDA.
You can get an in-depth overview of the process in our article “Usability Engineering for medical devices according to IEC 62366-1- We explain the process step by step“.
Conclusion
The MDR has regulated the requirements for medical devices in Europe since 2017. The general safety and performance requirements for medical devices set out in Annex I for manufacturers include some points relating to the Usability of the product.
Usability Engineering is assumed (although not explicitly required) by the MDR in order to comply with the regulation’s general safety and performance requirements. Thus, the appropriate Usability of a medical device is an essential part needed to get clearance for the European market in the first place.
How does the MDR affect your product? Feel free to comment on this post or get in touch via our contact form.
