Industry Insights

: 31 July

Everything you need to know about a Summary of Safety and Clinical Performance (SSCP) in one page!

: 29 July

ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice is now officially published !

The revised standard introduces various new requirements in an effort to establish a risk-based clinical investigation process and therefore take a step closer to harmonization with the new Medical Device Regulations.

: 28 July

Resources for Clinical Practice Guidelines

Discussion of Clinical Practice Guidelines is one of the most important parts of a MDR-compliant SoTA section because they collect and interpret all alternative treatment options for a given medical field and intended purpose from a clinical perspective.

Here are some sources to make your searches easier!

: 28 July

Summary of the main points of MDCG 2020-13

MDCGroup has published one of the most anticipated documents for the industry, namely the Clinical Evaluation Assessment Report (CEAR). Access the MDCSg 2020-13 document here
We have summarized the main points of interest for Manufacturers !

: 28 July

Conformity Assessment Routes applicable to EU-MDR

Content: We have prepared an overview of the available conformity assessment routes for each class device according to EU-MDR!