As a MedTech star-up, securing funding for a clinical investigation involves several steps and requires a well-structured approach, so don't rush and think on these tips...

The clinical performance and clinical benefit of a medical device have different definitions according to the MDR and MDCG guidance.

Complying with the MDR does not remove the obligation of sponsors to comply with other relevant legislation issued by the European Union or Member States in relation to clinical investigations.

The European Commission is proposing measures to enhance transparency in the Medical Device sector by speeding up the launch of some elements of EUDAMED.

Strong clinical evidence is needed for medical devices and in vitro diagnostics, through the implementation of clinical investigations and performance studies to achieve certification and market approval by a Notified Body (NB).

A Medical Device manufacturer needs to justify the choice of a Clinical Evaluator for a Clinical Evaluation Report (CER). So, who is a Clinical Evaluation Specialist according to MDR?

Don’t forget to assess and mitigate any clinical evidence gaps on a yearly regular basis, so your product doesn’t end up falling through the gaps.

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...