A number of regulatory requirements must be taken into account when introducing medical devices into…
Medical devices and healthcare
GDPR and clinical investigations: who is the data controller?
Understand who qualifies as the data controller in clinical investigations under the EU MDR and GDPR. Learn the roles of sponsors and investigators, the implications of joint controllership, and the legal responsibilities tied to personal data processing in clinical trials.
Distribution of Medical Devices in Global Markets
The global medical device industry operates within an increasingly intricate regulatory web. As healthcare innovation…
EU PMS requirements for medical devices under scrutiny of Dutch authority
Dutch audits reveal non-compliance with EU post-market surveillance (PMS) requirements for medical devices. Learn how to strengthen PMS systems for compliance and safety.
Anticipating and notifying supply interruptions or discontinuations under article 10a MDR and IVDR
Learn about the new Article 10a under EU MDR and IVDR, requiring manufacturers to notify authorities and stakeholders of potential medical device or IVD supply interruptions. Understand the scope, notification process, and exemptions, as well as how to comply with these regulations to ensure patient safety and continuity of care.
Distance sales devices: a look at EU requirements
Distance sales devices, sold through online platforms, must meet specific regulations outlined in Article 6 of the MDR and IVDR to ensure safety and performance. This includes devices used for remote healthcare services, even if not directly sold within the EU.
Mutual recognition of regulations between the EU and Switzerland
Discover how the EU and Switzerland maintain strong trade relations through mutual regulation agreements, enabling smoother market access for many products.
How to carry out clinical investigations of medical devices in the EU
To market medical devices in the EU, manufacturers must provide clinical data specific to the European population.
Selling Medical Devices in Europe as a Chinese manufacturer?
Stay informed on upcoming cosmetic regulatory changes. Learn about the deadlines and new requirements for compliance in 2024.
How to prepare for the proposed extension for IVD medical devices
The EU’s proposed extension for IVD medical devices aims to prevent shortages. Manufacturers must prepare by meeting IVDR requirements promptly.