UK Medical Device Regulations Delayed for 1 Year
The post-Brexit regulatory body said it will now introduce new medical device regulations in July 2024……
State-of-the-Art:Unpacking MDR’s Evolving Requirements
Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk management and clinical data may allow a clearer understanding of regulatory expectations to emerge…….
Would the New CMS Rule Harm Medtech?
Centers for Medicare and Medicaid Services (CMS) unveiled its 2023 payment proposal. Here's how it would impact some medical device companies and sectors……
A Haystack with No Needle: Is an Extractables Study Appropriate for Limited-Contact Devices?
Based on ISO 10993-18, some medical device manufacturers to wonder if an extractables study is required for all devices, regardless of duration of contact. Experts at Nelson Labs share their knowledge on the matter……
In Vitro Diagnostic Medical Devices Regulation Takes Effect
The deadline impacts new devices but amended regulation grants most IVDs (depending on their risk class) three to five more years to comply……
Exploring Valve Technology Requirements Under the New MDR
Among the many standards and regulations affecting the medical device industry is the European Parliament (EU) 2017/745 standard, also known as the Medical Device Regulation……
