New battery regulations adopted by the EU will affect UK medical device manufacturers. The regulations aim to achieve climate neutrality and will require compliance from both EU and UK-based companies placing batteries and battery-powered products on the EU market.
New European Battery Regulations: Impact on UK Medical Device Manufacturers
( Credit to: Med-technews )
New battery regulations recently adopted by the European Union (EU) will have significant implications for medical device manufacturers in the UK. The Regulation (EU) 2023/1542 on batteries and waste batteries aims to achieve climate neutrality by 2050 and plays a crucial role in enabling a safe, circular, and sustainable batteries value chain.
The Batteries Regulation will come into effect on February 18, 2024, and will be directly applicable in all EU Member States. However, it is important to note that the new regime must be complied with not only by EU-based companies but also by UK-based operators who place or put into service batteries and battery-powered products on the EU market.
While the impact of the new regulations will be felt by various industries relying on batteries, including consumer technologies and electric cars, it will also affect manufacturers of battery-powered medical devices and in vitro diagnostic devices. This may lead to overlaps with the transitional provisions of the Medical Devices Regulation (MDR) or In Vitro Diagnostic Device Regulation (IVDR). Companies in these sectors will need to conduct internal assessments to determine if their devices are subject to the obligations of the Batteries Regulation and whether they qualify for any exemptions or derogations.
Removability and Replaceability Requirement: Implications for Medical Device Design
One key requirement of the Batteries Regulation is that portable batteries weighing less than 5kg and not designed for industrial purposes or electric vehicles must be "readily removable and replaceable" by end-users during the product's lifetime. This requirement aims to extend the lifespan of products incorporating batteries so that they do not become obsolete once the batteries run out. Article 11 of the regulation will be applicable from February 18, 2027, three years after the application of the Batteries Regulation.
For some devices, complying with this requirement may necessitate design changes to accommodate the removability and replaceability criteria. These design changes could be considered "significant," as defined in the transitional provisions of the MDR and IVDR. This is particularly important for devices certified under the former Device Directives that rely on the MDR and IVDR transitional provisions to remain on the EU market. Such devices can only continue to be placed on the market until 2025-2028 (depending on the devices) if there are no significant changes in design or intended purpose. Changes in the source of energy, such as batteries, could be deemed significant according to the Medical Device Coordination Group (MDCG) guidelines.
Design changes on devices covered by CE certificates issued under the former Device Directives may require manufacturers to comply with the MDR or IVDR before the applicable transitional periods expire. This would involve undergoing the relevant conformity assessments to place the devices on the EU market.
Derogations and Exemptions: Navigating the Removability and Replaceability Requirement
While the removability and replaceability requirement is a key aspect of the Batteries Regulation, there are limited derogations and exemptions available. Article 11 allows certain products to have batteries that can be removed and replaced only by independent professionals. This applies to products primarily used in wet environments that require washability or rinsability, professional medical imaging and radiotherapy devices, and in vitro diagnostic devices.
The definition of "independent professionals" is crucial to the practical implementation of this derogation. According to the Joint Research Centre (JRC), independent professionals are operators with the technical competence to repair devices with integrated batteries. They must conduct their business in commercial premises and comply with the applicable national regulations for repairers of electrical equipment in the EU Member States where they operate.
In addition to derogations, two narrow exemptions exist where the removability and replaceability requirement does not apply. The first exemption covers electrical and electronic equipment (EEE) subject to EU legislation imposing a higher level of environmental and health protection related to the removability and replaceability of portable batteries. The second exemption applies to products where a permanent connection between the device and the portable battery is necessary for safety reasons or data integrity reasons.
Manufacturers seeking to benefit from these exemptions should be aware that they will be interpreted narrowly. Safety concerns should primarily be addressed by making the battery removable and replaceable by independent professionals. The JRC suggests using the classification system under the MDR/IVDR to identify devices that qualify for the exemption based on safety reasons. Devices excluded from the scope of the Directive on Waste Electrical and Electronic Equipment (WEEE Directive) and active implantable devices should fall within the exemption for safety reasons. Regarding data integrity reasons, the JRC clarifies that the main function of the device must be data collection and supply, and the specific reason justifying the exemption must relate to data integrity.
Implications for Medical Device Manufacturers and Compliance
The Batteries Regulation will come into effect on February 18, 2024, with the removability and replaceability requirement and other obligations applying from February 18, 2027. Overall, the regulation will impose additional burdens on medical device manufacturers, potentially impacting device designs and requiring some manufacturers to transition their devices to comply with the MDR or IVDR earlier than planned.
EU and UK-based companies planning to place or put devices into service in the EU market should conduct internal assessments to determine if their devices qualify for any derogations or exemptions to the removability and replaceability requirement. They should also consider if design changes are necessary and initiate discussions with their Notified Body for the required evaluations.
