Peru joins IMDRF, updated clinical trial guidance in Denmark, Romania implements new compliance requirements for professionals users, and more in this week's medical device regulatory update.
Peru has been accepted as an affiliate member of the International Medical Devices Regulators Forum (IMDRF), marking a significant step forward in enhancing the nation's medical device regulatory capacity. This membership allows Peru, represented by its Ministry of Health and Digemid, faster access to cutting-edge medical technologies and aligns Peruvian regulatory standards with international benchmarks. The membership aims to boost public health through improved access to safe and high-quality medical devices across the country.
Learn more about DIGEMID Peru Medical Device Registration.
The Danish Medicines Agency has released an updated version (v2.0) of its guidance on risk-adapted recording and reporting of adverse events in clinical trials, aligning with EU Regulation 536/2014. Available in both Danish and English, this update offers enhanced clarification on requirements for risk-based adverse event management. Stakeholders are encouraged to review the changes and provide feedback through the agency’s website.
The ANMDMR has announced new obligations for professional users of medical devices in line with Art. 933 para. (1) of Law 95/2006. Effective October 24, 2024, professional users must ensure that medical devices are only employed for their intended purposes—diagnosis, prevention, monitoring, and treatment of diseases. ANMDMR will conduct checks on compliance across healthcare providers and distributors to enforce these regulations, safeguarding device safety and effectiveness in medical practices.
The Norwegian Medicines Agency now has broader powers to grant exemptions from Icelandic labeling on certain medicinal packaging under specific conditions. These exemptions apply primarily to H-marked medicines used exclusively in healthcare settings and small inner packaging, allowing labels in English or Scandinavian languages where Icelandic is not deemed essential. These changes aim to improve access to essential medicines within Icelandic healthcare institutions. Updated application procedures and forms are available on the agency’s website in both Icelandic and English.
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The IVDR transition includes structured processes IVD manufacturers must follow to engage with Notified Bodies. Many IVD manufacturers are interacting with Notified Bodies for the first time and must understand what is required to ensure a successful partnership. In this article, Dr. Oliver Eikenberg clarifies what manufacturers must prepare and when to engage a Notified Body for IVDR CE Marking.
Class D IVD manufacturers face fast-approaching IVDR transition deadlines, though some are more familiar with the regulatory process. In this article, Dr. Oliver Eikenberg discusses the difference between "new" and "old" Class Ds, and regulatory logistics they need to consider during the transition process.
Your IVD's intended purpose determines its classification, clinical evidence requirements, and clinical applications under the IVDR. Device companies will need a more robust intended purpose to fulfill IVDR criteria. In this article, Dr. Oliver Eikenberg explains the role of the intended purpose in IVDR compliance.
