New battery regulations in Europe, which were set to take effect from July 2023, will introduce significant changes for medical device manufacturers in the UK. The new regulations aim to reduce the impact on the natural environment and work towards achieving the EU’s climate neutrality by 2050.
The regulations will come into force on February 18, 2024, and will apply to all EU member states. They not only apply to EU companies but also to any UK companies that introduce batteries and battery-powered products to the EU market.
Medical device manufacturers can expect changes in design as the new regulations require batteries to be replaceable. This means ensuring that batteries in medical devices can be easily replaced by end-users during the product’s lifespan. The aim of these regulations is to extend the lifespan of battery-operated devices, so they do not automatically become obsolete once the batteries are depleted.
Medical device manufacturers are advised to conduct an internal assessment to determine whether the new regulations apply to their products and whether they can benefit from any exceptions or derogations. Design changes may be necessary and sometimes considered “significant” in the context of transitional provisions for medical devices. This is particularly relevant for devices that have obtained CE certificates under previous directives and rely on transitional provisions to remain on the EU market.
Battery regulations require medical manufacturers to publish guidelines that facilitate the harmonization of battery interchangeability principles. While exceptions to battery interchangeability are limited, there are also exemptions for certain products used in wet environments or requiring professional handling.
The new battery regulations in Europe will have significant implications for medical device manufacturers in the UK. Design changes and assessment of product compliance with the new regulations will be necessary. It is important to consult with relevant regulatory authorities to understand how they impact specific products and what exemptions and derogations are available. The implementation of these regulations aims to enhance environmental protection and promote a more sustainable value chain in the medical sector.
FAQs on Battery Regulations for Medical Device Manufacturers in the EU
The source of the article is from the blog publicsectortravel.org.uk