IVDR Class D Diagnostics Transitional Provisions Q&A Updates
To support the diagnostics sector, the Medical Device Coordination Group (MDCG) has released an updated Q&A document regarding the transitional provisions for the certification of Class D diagnostics. This update is crucial for manufacturers and stakeholders navigating the complexities of regulatory compliance under the In Vitro Diagnostic Medical Devices Regulation (IVDR). Class D diagnostics are […]
Device Classification
Background and Problem A US based manufacturer of sample preparations reagents and instruments needed an outside opinion of their regulatory compliance regarding labeling certain devices as “Research Use Only (RUO)” in the United States and the European Union. The manufacturer also wanted assistance to develop an approach on how best to register and list a […]
EU Publishes Regulation (EU) 2024/1860 Amid Device Supply Chain Concerns
In response to increasing concerns over supply chain stability and its impact on healthcare delivery, on June 13, 2024 the European Union published Regulation (EU) 2024/1860 of the European Parliament and of the Council which amends both the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to introduce new obligations for companies facing […]
MDCG Revises Guidance on Classification for In Vitro Diagnostics
In a move poised to reshape the regulatory landscape for in vitro diagnostics (IVDs) across Europe, the Medical Device Coordination Group (MDCG) has released new guidance on classification rules. This July 8, 2024 update is the third revision of the guidance and aims to bring clarity and consistency to the classification of IVDs, ensuring that […]
The EU IVDR Impact on Clinical Trials
The European Union In Vitro Diagnostic Regulation (EU IVDR) stands as a pivotal framework shaping the landscape of medical device regulation within the EU. While primarily targeting in vitro diagnostic (IVD) devices, its ramifications extend beyond mere device certification. Among its ripple effects lies a significant impact on clinical trials, particularly those involving IVDs. Understanding […]
The MHRA Roadmap: Navigating the UK Market
While the European Union (EU) remains hard at work in developing its new regulatory framework for medical devices under the MDR and IVDR, the UK has extended deadlines for the use of currently CE-marked medical devices to be sold in Great Britain (GB) and provided information on transition timelines. Under this transition: Additionally, self-declared CE-marked […]
EU Commission proposes another extension for IVDR transition
On January 23rd, amid concerns that there is not enough time for manufacturers to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR), the EU Commission announced another proposal to extend the transition period. Previously extended at the end of 2021, this is the second time the Commission will look to provide additional time […]
MDCG UPDATES Q&A ON IMPORTERS AND DISTRIBUTORS
The Medical Device Coordination Group (MDCG), the regulatory body that works toward ensuring the safe and effective use of medical devices in Europe, recently updated a Q&A document on how both the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) apply to importers and distributors. Under both regulations, an economic operator is defined […]
MANAGING CHANGES AND MAINTAINING COMPLIANCE
Under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), devices need to meet the applicable “harmonized standards” to demonstrate conformity with the essential requirements. If a harmonized standard referenced in the technical documentation (including the DHF) is updated, manufacturers are expected to assess the impact and incorporate any necessary changes […]
