The new MDR deadline extension brings a new definition for legacy devices, and a list of conditions now applies for them to remain in the market.

Total Product Lifecycle is the competitive advantage to uncertainty in terms of ever changing regulatory landscapes and new fast developing technologies. It will keep your device on a straight path of continued success.

Much confusion exists regarding the use of medical devices in clinical trials and which rules apply to what. In case a medical device is involved in a clinical trial, then three possibilities arise...

MDR/IVDR deadlines extension proposal: higher risk devices until December 2027; and, medium and lower risk medical devices until December 2028. Manufacturer needs to have started the Notified Body application process before 26 May 2024.

The depth, breadth and scrutiny on clinical data is much more rigorous; and, it needs to be backed by a thorough literature search.

Regardless of a medical device class, or it's intended use, design, or even the safety history, the Technical File file is a live document of transparency and safety.

FDA latest guidance for 510 (k) regulatory submissions in an electronic format: eSTAR.

How to improve your Clinical Evaluation Report (CER) for MDR compliance and Notified Body certification, here are some tips...

Explain your device to your health-care users and patients with an updated Summary of Safety and Clinical Performance (SSCP).

Clinical Evaluation Report (CER) updates according to the MDR (EU) 2017/745

EU IVDR 2017/746 will enter into force on the 26th of May 2022: here is all the important juice...

The German Federal Institute for Drugs and Medical Devices, has given a workshop about the Oligonucleotide CMC Strategies for Quality Control. For oligonucleotides, starting materials are very important for the overall control strategy...