Regulatory Outlook

Products | Regulatory Outlook June 2022

Published on 20th Jun 2022

This month we cover the EU's agreement on a common charger, an OPSS report on the impact of artificial intelligence on safety, new MHRA guidance on notifications about clinical investigations medical devices, and more

Row of people all holding and looking at their phones

Common Charger agreed by European Commission

On 7 June 2022, the European Parliament and Council announced that they had agreed that USB type-C will become the common charging port for all small and medium sized electronic devices in the EU by Autumn 2024.

The press release also states that fast charging speeds will be harmonised, and laptops will need to be adapted forty months after the entry into force, which differs from previous updates that noted devices already on the market would not be affected by these amendments. 

We await further details on these new amendments. The final version agreed by the Parliament and Council will be made publicly available after the summer recess.

UK government launches consultation on units of measurement

On 3 June, the Office for Product Safety and Standards (OPSS) and Department for Business, Energy & Industrial Strategy (BEIS) launched a consultation inviting views on the choice over the units of measurement used in consumer transactions. The consultation is in line with the government's plan to review the law on units of measurement following the UK's exit from the EU. The consultation will explore the appetites of businesses and consumer to buy and sell in imperial units. 

The consultation is specifically seeking views from those who are affected by the legislation, including:

  • Businesses – the consultation would like to understand the likely uptake of selling solely in imperial measures, or in imperial units with a less prominent metric equivalent; and the costs and benefits related to both options. It also asks for businesses views on potential impacts to their customer base and suppliers.
  • Consumers – whether the introduction of imperial unit as the only or primary unit of measurement would change their shopping habits.
  • Local Authority Trading Standards – interested in knowing if there will be any potential impact on their regulatory activity, including any costs or benefits.

The consultation closes on 26 August. 

It should be noted that the consultation has been wildly criticised by retailers for the burdens this initiative could introduce, as products would need to be relabelled, and could also push up the price of goods for consumers. Moving away from metric measurements and reintroducing imperial is also likely to confuse consumers who have been bought up with metric units and are unfamiliar with imperial measurements. With the consultation already facing a lot of backlash from stakeholders, it will be interesting to see whether the government takes further steps to make any changes.

OPSS: Study on the impact of artificial intelligence on product safety

On 23 May, the Office for Product Safety and Standards (OPSS) published a research report, Study on the Impact of Artificial Intelligence on Product Safety. The report focuses on the current and future impacts of artificial intelligence (AI) on consumer products and product safety.

The paper highlights that the use of AI brings both opportunities, as well as challenges and risks. For example, AI technology can advance products by making them more efficient and effective, which can improve product safety. Other indirect opportunities include improved data collection, improved cyber security protection, AI powered product design and an increasing potential for personalised products.

On the other side, the report notes the potential challenges around robustness and predictability, transparency and explainability, security and resilience, fairness and discrimination, and privacy and data protection. It also sets out the potential harms, which includes "material harms", such as an AI-driven robot causing physical injury, and "immaterial harms" such as the replacement of human contact for older people with autonomous products causing mental health issues.

The regulatory challenges are also explored. The report highlights that the more complex AI products challenge many of the definitions detailed in the current regulatory regime, and that this legal uncertainty will need to be addressed.

MHRA updates medical device clinical investigations guidance

The MHRA has updated its guidance on notifications about clinical investigations for medical devices. A new section on study deviations has been added to the guidance outlining that medical device manufacturers must give notice to the MHRA of all deviations as soon as they have been made aware of them. The notice should include details about the nature of the deviation, when it occurred, where it occurred, and the corrective and preventative actions proposed by the manufacturer. Manufacturers should use this excel template when reporting deviations and keep this as a "live" document so that new deviations can be added.

MDCG issues guidance on application of IVDR to 'legacy' and 'old' devices

The Medical Device Coordination Group (MDCG) has published guidance on the application of Regulation (EU) 2017/746 on in vitro diagnostic devices (IVDR) to "legacy" and "old" devices.

The document outlines that under 110(3) of the IVDR, "legacy" devices are those that:

  • Are placed on the market or put into service after 26 May 2022 and up to the end of the relevant transition periods.
  • Were authorised under Directive 98/79/EC on in vitro diagnostic devices (IVDD), meaning that they are the subject of either a valid EC certificate issued by a notified body or a declaration of conformity without notified body involvement (but in a situation that would require notified body involvement under the IVDR).
  • Comply with the further requirements of the IVDR specified by Article 110(3); that is, they continue to comply with the IVDD and have not undergone any significant changes in their design and intended purpose.

"Old" devices are those that were placed on the market or put into service prior to 26 May 2022, and are still on the market or in use after 26 May 2022 The guidance outlines that the IVDR requirements are in principle not applicable to "old" devices. However, IVDR provisions should generally apply if they do not directly impact the device, its documentation or the conditions for the placing or making available of devices on the market. 

Guidance issued on new extended producer responsibility for packaging

Please see Environment.

Single use plastics in Scotland 

Please see Environment

Commission launches call for evidence on prohibiting products produced using forced labour

Please see Modern Slavery


* This article is current as of the date of its publication and does not necessarily reflect the present state of the law or relevant regulation.

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