EU MDR

Being a medical device manufacturer involves more than the actual manufacturing of the medical devices. A manufacturer's job is not only to come up with a device that will be beneficial to the patient [...]

The MDCG Guidelines recommend the application of the International Medical Device Regulators Forum (IMDRF) risk categorization framework to help with risk classification of new or unknown software through an understanding and analysis of two critical [...]

The new clinical trial regulations that are in place right now will streamline applications and increase transparency.   The current clinical trials regulatory framework for the European Union (EU) has entered into effect this [...]

For any medical device, there must be sufficient clinical evidence to corroborate compliance with relevant essential requirements for safety and performance. One of the most crucial components for a thorough and complete Clinical Evaluation [...]

  Making a medical device means you're in the business of saving lives—and that's nothing to sneeze at. As if that wasn't enough pressure, you now have to deal with the labyrinthine EU certification process. [...]

 The European medical device regulations (MDR) provide a minimum standard in Europe for health equipment manufacturing or exporting. We know it is hard enough to remember the new changes and guidelines when it comes to MDRs. Keeping [...]

The work of a literature review is not merely to be submitted as a part of the submission document. A good literature review can do half of the job for the marketers developers alike, all [...]

Medical device manufacturers conduct clinical investigations to ensure that products meet the rules. To most, it is simply a necessity in order to get their medical devices approved. However, in some cases, the clinical [...]

This document intends to cover a comprehensive framework for each of your products. Use it as a guide to direct your staff in the various parts of Post Market Surveillance (PMS) for MDR compliance! [...]

  No matter how hard you try as medical device manufacturer to make sure your device is safe and efficient, adverse events can still happen. Even the most vigorously tested medical devices have adverse [...]

MDCG’s Guidance document, released in July 2020, introduces and details the key requirements and format of a Clinical Evaluation Assessment Report (CEAR) to be documented by Notified Bodies (NBs) as a part of its [...]

    For manufacturers, clinical trials or at least the protocol are already planned and set to go for up to 2023. However, a new development in the clinical trials regulation means what you [...]