How Will Brexit Affect the Implementation of Human Factors Engineering for Your Device?

Introduction

The UK’s adoption and implementation of the new EU Medical Device Regulation (MDR)1 is one of the key challenges posed by Brexit. The MDR makes significant stipulations for the implementation of Usability Engineering throughout the Total Product Life Cycle. In April 2019, the British Parliament formally signed into law special amendments and affirmations to the Medical Device Directive (2002) and the MDR (2017), as both bodies of law will have jurisdiction in the UK through at least 2025. It is important to understand that, as this regulation relates to Human Factors Engineering, there are very few differences between the UK and the EU at the moment.

Much of the Brexit legislation issued to align with MDR helps conform the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) with the requirements for reporting and registration prescribed in the EU's notified bodies scheme. There is one notable change in the regulation pertaining to usability; this particularly pertains to patient information for implanted devices.

Amendments to Body of Medical Device Regulations (Regulation 10)

The following is the text from MDR Article 18: Implant card and information to be supplied to the patient with an implanted device:

“The information...shall be written in a way that is readily understood by a lay person and must be updated where appropriate..."

The following is the amended text from the Brexit legislation:

“The information...must be written in a way that is readily understood by a lay person and must be updated where appropriate, such updates being made available to the patient on the manufacturer’s website..."

The MDR phrasing of this clause implies that readability of implant cards and associated information must be determined pre-market. The MDR does not emphasize the need to update implant cards and information based on post-market data. This rephrasing implies that post-market data related to usability should be incorporated in implant cards and information supplied to the patient. The UK regulation also notes that any updates to information, made post-market, must be readily available to the patient on the manufacturer’s website.

A Note on Post-market Surveillance

The MDR requires that:

“data gathered by the manufacturer’s post-market surveillance system shall in particular be used... for the identification of options to improve the usability, performance and safety of the device.”

This stipulation broadly shows a fairly monumental change in regulatory oversight of post-market surveillance, as data must now be gathered prospectively with the aim of continuous usability improvement. This requirement is reiterated in the UK regulation.

It should be noted that the 2017 MHRA guidance on human factors placed emphasis on “post-market vigilance.” It states that:

“Manufacturers should actively and systematically seek views of users and also ensure they are aware of any issues on related device types that they would need to take into account.”

Furthermore, the MHRA holds that this “ongoing review of data” should serve as an iterative input to the use-related risk analysis. Taken with the MDR, this shows a global trend towards the integration of post-market surveillance into human factors engineering in the total product life cycle.

Conclusion

Overall, the most notable impact of Brexit legislation on human factors engineering is the continuity it provides as the UK leaves the European economy. Keeping your HFE process up to date with MDR compliance should also maintain compliance with the MHRA.

ClariMed is an expert in MDR and will continue to stay up to date with the regulatory landscape of the UK and the EU to help you achieve CE mark.

References:

EU MDR - Regulation (EU) 2017/745

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, UK

UK’s EU exit legislation, http://eumdr.com/uk-exit/

Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products, September 2017, MHRA