๐ต๐๐ ๐น๐๐๐๐๐๐๐๐๐ ๐จ๐๐๐๐!
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.
๐๐๐ง๐ฎ๐๐๐๐ญ๐ฎ๐ซ๐๐ซ๐ฌ ๐๐ง๐ ๐๐ฎ๐ญ๐ก๐จ๐ซ๐ข๐ฌ๐๐ ๐๐๐ฉ๐ซ๐๐ฌ๐๐ง๐ญ๐๐ญ๐ข๐ฏ๐๐ฌ (๐๐ฎ๐๐ก ๐๐ฌ ๐๐ง๐ญ๐๐ซ๐ง๐๐ญ๐ข๐จ๐ง๐๐ฅ ๐๐ฌ๐ฌ๐จ๐๐ข๐๐ญ๐๐ฌ ๐๐ข๐ฆ๐ข๐ญ๐๐)
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 (legislation.gov.uk)
For amended guidance, refer to: Regulation of devices in Northern Ireland – GOV.UK (www.gov.uk)
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