Product regulation continues to advance at a fast pace and there are a number of recent pieces of legislation that manufacturers of goods need to consider. The wearables industry continues to boom and we look at some of the key regulatory and legal risks arising for manufacturers in this space. We also consider some recent and upcoming reforms, including the Accessibility Directive and the Single Use Plastics Directive.

Fitness trackers & wearables – what are the regulatory risks?

Fitness trackers, bodytech, wearables and associated apps, also known as “Wearables”, range from basic recording of activity levels like step counts, to more advanced physiological indicators like heart rate and blood pressure. No matter the type of information recorded, the legal risks are largely the same for all players in this market.

Is it a ‘medical device’?

The first question to ask is whether the Wearable is a medical device. Put simply, is the device intended to be used for medical purposes i.e. diagnosis, treatment, etc.? If it falls within the definition of a medical device, it will be subject to the Medical Devices Directive, or the Medical Devices Regulation (MDR) from May 2020 and compliance with numerous requirements will be required, including those related to:

  • Clinical investigations

  • Conformity assessments

  • CE marking

  • Post market surveillance

The consequences of selling or promoting a Wearable, which is actually a medical device, without regulatory compliance could result in monetary fines or even imprisonment depending on what legislation the enforcement action is brought under. Associated software, including related apps or algorithms, also require careful consideration as these aspects may be considered software medical devices or in some circumstances, accessories to the hardware product. If so, they will also be subject to certain requirements under the medical devices framework.

How safe is the hardware and the software?

Wearables, including the accompanying software, cannot be placed on the market if they are not considered ‘safe’ according to EU and Irish product safety rules. This will apply to a watch, bracelet or wrist device (as ‘products’) and is something manufacturers need to be mindful of.

What about reliability?

Reliability and accuracy of the data generated by Wearables comes into sharp focus when the Wearable is being used for health reasons and the manufacturer knows this. If the Wearable is unreliable in how it records data, the question arises as to whether that makes it unsafe under EU product safety rules when used for these purposes. Manufacturers should always consider their obligations and duties to users, including appropriate disclaimers and warnings.

Wearables are subject to significant regulatory regimes and compliance needs to be considered very carefully to prevent these products from falling foul of conformity with safety and consumer protection requirements.

The Single-Use Plastics Directive

The new Single-Use Plastics Directive (EU) 2019/904 bans certain single-use plastic products and imposes measures to reduce consumption, extend producer responsibility and design requirements for beverage containers. This covers disposable products that are designed to be used only once, or for a short period of time before being thrown away.

Some of the key elements of the Single-Use Plastics Directive are:

Prohibited products: 10 single-use plastic products for which alternatives are readily available on the market are banned. Examples include cotton bud sticks, cutlery, plates, straws, drink stirrers and balloon sticks, as well as food and beverage containers made of expanded polystyrene.

  • Reduced consumption: measures to reduce consumption of food containers and beverage cups made of plastic.

  • Labelling requirements: specific clear and standardised labelling of certain products indicating how the waste should be disposed, the negative environmental impact of the product and the plastics contained in the product.

  • Separate recycling collections: EU Member States must take measures to ensure separate recycling collections for single-use plastic beverage bottles. Plastic bottles will have to contain at least 25% of recycled content by 2025 and 30% by 2030.

  • Extended producer responsibility: Producers will be responsible for supplementary costs associated with certain single-use plastic products. Supplementary costs include costs of awareness raising measures, waste collection costs and litter clean-up costs

EU Member States must bring laws, regulations, and administrative provisions necessary to comply with this Directive into force by 3 July 2021. This timeframe can be extended to 3 July 2024 to apply measures to ensure that certain single-use beverage containers that have caps and lids made of plastic may only be placed on the market if the caps and lids remain attached to the containers during the products’ intended use storage.

The Accessibility Directive

The new Accessibility Requirements for Products and Services Directive (EU) 2019/882 introduces accessibility requirements for specific products and services such as phones, computers, payment terminals, banking services and e-commerce services.

The key requirements include:

  • Consumer products must be capable of being operated by persons with disabilities and have packaging, installation instructions and other product information that is accessible

  • Manufacturers of products must demonstrate compliance with the applicable accessibility requirements by drawing up an EU declaration of conformity and affixing a CE mark

  • Websites and apps must be easily operable and understandable for persons with disabilities and include accessibility information, which must be made available by more than one sensory channel, presented in an easily understandable and perceivable way

EU Member States must bring laws, regulations, and administrative provisions necessary to comply with this Directive into force by 28 June 2025.

The New Safety Standard IEC 62368-1 for ICT and AV Equipment

Those who manufacture audio-visual products or computing/communications equipment in the EU should take note that the safety standards that have traditionally applied to these products, IEC 60065 and IEC 60950-1 respectively, will be superseded by a single standard IEC 62368-1. The date from which these standards will cease to apply is 20 December 2020.

The new standard will introduce a new hazards-based testing method, and from 20 December 2020, existing products using either of the current two standards may have to be re-tested to achieve conformity with the new standards, along with preparing new declarations of conformity for such products placed on the market after 20 December 2020.

Conclusion

As we look ahead to 2020 there are a lot of regulatory changes coming down the track that manufacturers of products need to be aware of and plan for accordingly. In particular, with less than six months to go until the new MDR comes into force, medical device manufacturers (including app developers) need to ensure regulatory compliance, and should be preparing now for the impact of the MDR on their business. It remains to be seen whether a deal will be reached on Brexit and how this will impact the product regulatory sphere.