Introducing the Medical Devices

Introducing the Medical Devices

𝑵𝒆𝒘 𝑹𝒆𝒈𝒖𝒍𝒂𝒕𝒊𝒐𝒏 𝑨𝒍𝒆𝒓𝒕!
Introducing the Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024.

Attention, manufacturers! This regulation, now in force, brings crucial updates to ensure the safety and quality of in vitro diagnostic devices (IVDs) and other medical devices.

Manufacturers, compliance is key! Here are the specific requirements mandated by these amendments:

  • Thorough documentation of product specifications.
  • Adherence to updated standards for development, testing, and distribution.
  • Implementation of robust testing procedures.
  • Establishment of comprehensive quality control measures.
  • Enhanced transparency and accountability throughout the manufacturing process.

𝐌𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐞𝐫𝐬 𝐚𝐧𝐝 𝐀𝐮𝐭𝐡𝐨𝐫𝐢𝐬𝐞𝐝 𝐑𝐞𝐩𝐫𝐞𝐬𝐞𝐧𝐭𝐚𝐭𝐢𝐯𝐞𝐬 (𝐒𝐮𝐜𝐡 𝐚𝐬 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐀𝐬𝐬𝐨𝐜𝐢𝐚𝐭𝐞𝐬 𝐋𝐢𝐦𝐢𝐭𝐞𝐝)

If you are manufacturing or placing a medical device on the Northern Ireland market, you must meet the applicable obligations set out in the respective regulations, including, but not limited to, ensuring that:

The device has been correctly classified against the risk classification criteria (Annex VIII of the MDR and IVDR)
General safety and performance requirements are met, including labelling, technical documentation and quality management systems (Annex I of the MDR and IVDR)
Requirements for clinical evidence are met (Annex XIV of the MDR and IVDR)
Requirements for the person responsible for regulatory compliance are met (Article 15 of the MDR and IVDR)

Stay informed and ensure your operations align with these regulations to uphold safety and quality standards in the healthcare industry.

Read the fill regulation text here: The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (

For amended guidance, refer to: Regulation of devices in Northern Ireland – GOV.UK (

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