{"id":491,"date":"2025-11-05T10:29:26","date_gmt":"2025-11-05T10:29:26","guid":{"rendered":"http:\/\/www.cpsl.com\/?page_id=491"},"modified":"2025-12-04T10:52:45","modified_gmt":"2025-12-04T10:52:45","slug":"white-paper__ready-eu-regulations","status":"publish","type":"page","link":"https:\/\/www.cpsl.com\/en-GB\/white-paper__ready-eu-regulations\/","title":{"rendered":"CPSL Landing EU Regulations 2022 UKEN"},"content":{"rendered":"

In May 2017, it was announced that the Medical Device Directive (MDD), the In Vitro Diagnostic Medical Devices Directive (IVDD), and the Active Implantable Medical Device (AIMD) Directive would be replaced by the new MDR and IVDR standards in order to improve clinical safety for patients and users, standardise and harmonise information, and provide a level playing field for both healthcare professionals and manufacturers. In 2024, updates to the MDR and IVDR regulations were introduced.<\/em><\/strong><\/h3>\n

The MDR came into force in May 2021<\/a>, closely followed by the In Vitro Diagnostic<\/a> Regulation (EU) 2017\/746 (IVDR), the new EU legislation applicable to in vitro diagnostic (IVD) medical devices that replaced the EU In Vitro Diagnostics Directive 98\/79\/EC (IVDD). The IVDR became applicable on 26 May 2022, but the length of the transition period now depends on the class of the device, following amendments introduced by Regulation (EU) 2022\/112<\/a> and further refined by Regulation (EU) 2024\/1860.<\/a><\/p>\n

These updates extend the transitional timelines for many IVD devices, giving manufacturers additional time to obtain certification under the new rules, whilst continuing to adhere to existing safety and performance requirements. This flexibility seeks to prevent shortages of essential devices and reduce pressure on the notified bodies that conduct conformity assessments.<\/p>\n

According to the European Commission, these measures were necessary due to the \u201cimminent risk of shortages of medical devices and the associated risk of a public health crisis<\/em>\u201d.<\/p>\n

At the same time, the rollout of the EUDAMED database is progressing. Under Regulation (EU) 2024\/1860, EUDAMED modules \u2014 such as actor registration, UDI\/device registration, and notified bodies and certificates \u2014 will become mandatory six months after being declared fully functional and published in the Official Journal of the EU, with full operational use expected during 2026\u20132027.<\/a><\/p>\n

The European Commission has also announced that it will conduct a comprehensive evaluation of the MDR and IVDR frameworks by May 2027 to assess implementation challenges and explore potential improvements.<\/p>\n

Under the IVDR, manufacturers of IVDs wishing to place their products on the European market are required\u00a0to:<\/p>\n