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At Reed Tech Life Sciences, we know the challenges of locating and securing important documentation for both internal and external downstream users. In a recent webinar presentation, Reed Tech Alliance member, Greenlight Guru, showcased how their solution empowers...
LexisNexis® Reed Tech has teamed up with Greenlight Guru, the leading Medical Device Success Platform for medical device companies. Horsham, Pa., USA – February 24, 2022 – In response to the needs expressed by medical device manufacturers for ways to effectively...
Determining Software as a Medical Device is essential for regulatory compliance. This involves classifying software as a Device Component, Accessory, or Standalone Device, and understanding FDA’s UDI requirements and the implications of software changes on device identification.
A frequent question on medical devices concerns determining ‘if’ a product is defined by US FDA as a ‘medical device’. Intended Use and Indications for Use are key determiners and FDA provides clear guidance. Packaging and accessory definitions can be reasons for...
Unique Device Identification is a globally unique, unambiguous identification comprised of a Device Identifier (DI) and a Production Identifier (PI). UDI is specific to a device model and version of that device on the market.
The European Union (EU) requires manufacturers to supply ‘implant cards’ for patients with implanted medical devices, as prescribed in Article 18 of Regulation (EU) 2017/745 on medical devices. The requirement’s purpose is to give patients easy access to important...
Polls conducted May 20, 2021 Survey ResultsAre you as a medical device manufacturer, in the middle of preparing for the EU Medical Device Regulation (MDR)? Many are trying to figure out their response to the European Commission's notice that the EUDAMED launch was...
Did you know there are multiple health authorities around the globe with current or future requirements for medical device product data specifically for Unique Device Identification (UDI) standards? The list continues to grow (US FDA, EU EUDAMED, South Korea MFDS,...
For medical device manufacturers and distributors, UDI product data submission to Health Authorities/Regulators is a multi-step process with rules and goals, much like a ‘team sport’.
Are UDI requirements in South Korea similar to other health regulators? The short answer is 'not exactly'. In this episode of Reed Tech Insights, we discuss the legislation, policy, timing and data attributes involved in the South Korean Unique Device Identification...