Policies & Regulations
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2023.01.10
European Commission endorses MDR transition delay
An MDR transition delay is one step closer to reality following concerns that the current timeline could lead to medical device shortages.
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2022.11.01
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……
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2022.10.25
FDA efforts to prioritize medtech innovation pay dividends
A decade ago, medical device companies often turned to Europe to score initial regulatory approval for new products. Even though the U.S. is a larger market, many companies looked to Europe to win regulatory approval for their medtech innovation efforts……
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2022.08.15
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…….
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2022.08.04
FDA eases UDI compliance requirements for some low-risk medical devices
The U.S. Food and Drug Administration has exempted low-risk medical devices considered consumer health products from some Unique Device Identification compliance requirements in accordance with least burdensome principles……
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2022.07.13
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……
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2022.06.27
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……
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2022.05.31
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……
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2022.05.23
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……
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2022.04.28
Moody’s warns of cybersecurity, antitrust and supplier risks for medical device companies
Medical device companies face heightened cybersecurity burdens, antitrust enforcement and supplier risks, according to a new report out of Moody’s…….
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