Harmonised standards for sterilisation of health care products.

On 4th July, the European Commission issued a new?Commission Implementing Decision (EU) 2023/1410,?which amends Implementing Decision (EU) 2021/1182 as regards harmonised standards for sterilisation of health care products and biological evaluation of medical devices. The new decision comes into force on 20 July 2023 and introduces a number of new requirements for medical device manufacturers and developers.

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A refresher?on Harmonised Standards?- A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN or CENELEC. It is created following a request from the European Commission to one of these organisations. Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation.

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The references of harmonised standards must be published in the Official Journal of the European Union (OJEU). The purpose of this website is to provide access to the latest lists of references of harmonised standards and other European standards published in the OJEU.

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Going back to 4th July’s update, our experts could present the following takeaways:

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• The document amends Implementing Decision (EU) 2021/1182, which sets out the harmonised standards that must be used for the sterilisation of healthcare products and the biological evaluation of medical devices.
• The amendments include the addition of new harmonised standards, the removal of outdated standards, and the revision of some existing standards.
• The amendments are intended to ensure that the harmonised standards reflect the latest scientific and technical developments in the field of sterilization and biological evaluation of medical devices.
• Manufacturers and developers of medical devices must ensure that their devices comply with the amended harmonised standards.
• They must update their risk assessments and post-market surveillance plans to reflect the changes to the harmonised standards.
• They must notify the relevant authorities of any changes to their devices that may affect their compliance with the amended harmonised standards.

The deadline for compliance with the new requirements is 20th July 2023. However, if you are unable to comply with the new requirements by this date, you may be able to apply for an extension from the relevant authorities.

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The following standards were added to the list of harmonised standards:

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• EN ISO 10993-10:2023 Biological evaluation of medical devices – Part 10: Tests for skin sensitisation

The following standards were revised :

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• EN ISO 25424:2019/A1:2022, Sterilisation of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilisation process for medical devices.

What You Need to Do?

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If you are a medical device manufacturer or developer, you must take steps to ensure that your devices comply with the new requirements. This includes:

• Reviewing the amended harmonised standards and identifying any changes that affect your devices.
• Updating your risk assessments and post-market surveillance plans to reflect the changes to the harmonised standards.
• Amending your Regulatory Strategy.
• Notifying the relevant authorities of any changes to your devices that may affect their compliance with the amended harmonised standards.

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Our Experts can support you with

• Harmonised Standard Compliance
• Regulatory Strategy Alignment
• Transition assistance - smoothly transitioning from the previous directives (90/385/EEC and 93/42/EEC) to Regulation (EU) 2017/745, including updating documentation, conducting assessments, and ensuring compliance with the new regulations.
• Risk Management Analysis
• And when the regulators find you non-compliant and take action against your medical device, we can provide you with Product Recall Management Support.

Early prevention and adaptation of regulatory requirements can save your Medical Products from going ‘off the shelves!’

Engage with our RAQA experts today!

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Drop us an email – [email protected]

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