Medical device definition

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Life sciences divergence tracker 2021–2023 [Archived]

Life sciences divergence tracker 2021–2023 [Archived] ARCHIVED: This Practice Note has been archived and is not maintained. This Practice Note served as a reference guide to monitor relevant EU-UK divergence in the legislation and guidance of interest to the life sciences sector from the end of the Brexit implementation period (eg 31 December 2020) following the UK’s decision to withdraw from the EU through 2023. Where applicable, it also includes key points of divergence within the UK (between Great Britain (GB) and Northern Ireland (NI)). In this Practice Note, the term ‘divergence’ refers to differences in the legislation, guidance or required standards which arise following IP completion day (11 pm on 31 December 2020). A parallel but identical or substantially similar regime would not constitute ‘divergence’. See also related Practice Notes: • Post-Brexit transition period—the regulation of medicinal products • What does IP completion day mean for Life Sciences? [Archived] • Medicines and Medical Devices Act 2021 • What does IP completion day mean for medicinal products?...

US—IP protection comparison for literary works; marketing images, characters, and slogans; product designs; and inventions

US—IP protection comparison for literary works; marketing images, characters, and slogans; product designs; and inventions This Practice Note was originally written for Lexis Practice Advisor®, in the US. This Practice Note compares and contrasts the types of protection that are available for common types of IP, including literary works (copyright and trade secret); marketing images, characters and slogans (copyright and trademark); product designs (design patent, copyright and trade dress) and inventions (patent and trade secret). Literary works—copyright versus trade secret protection For something to qualify as a trade secret, it must actually be a secret, the owner must expend efforts to protect the secrecy, and it must provide the owner with a competitive economic advantage. Trade secrets generally tend to include commercial or business information and can last indefinitely, as long as the secret is not disclosed. Copyright protection, on the other hand, covers such matter as literary works, audiovisual works, and sound recordings and merely requires that the work be fixed in a tangible medium of expression. Copyright...

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Medical devices due diligence questionnaire

Medical devices due diligence questionnaire Introduction This medical devices regulatory due diligence questionnaire relates to the proposed purchase by [insert buyer name] (the Buyer) of the [entire share capital of [insert name of target company] Limited incorporated in England and Wales under number [insert company number] (the Company) OR [insert description of the business to be acquired] (the Business) as a going concern, together with certain assets used in the Business ] from [insert seller name] (the Seller) (the Proposed Acquisition). This questionnaire is designed to enable the Buyer, the Buyer’s solicitors and other professional advisors to obtain the legal information relating to the medical devices regulatory compliance of the [Company OR Business] which the Buyer requires to assist in the valuation of the [Company OR Business] and with the negotiation of the Proposed Acquisition. Please answer every question fully. Please provide your answers in italics underneath each question and provide copies of all relevant documentation, ensuring that...

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Which laws and regulations govern health care apps (mHealth)?

Which laws and regulations govern health care apps (mHealth)? Regulation as a medical device An app may, depending on the specific characteristics and intended use, fall within the definition of a medical device. Practice Note: An introduction to the regulation of medical devices—EU Directives regime provides a useful starting point. The regulatory regime imposes obligations on manufacturers of medical devices and in vitro diagnostic medical devices to ensure that their devices are safe and fit for their intended purpose. In order to be placed on the market in the EU, all medical devices must meet the 'essential requirements' set out in the relevant medical device directive. To determine whether the app would fall subject to the medical device regulatory framework, the section ‘An introduction to the regulation of medical devices—EU Directives regime—What is a medical device?’ from the aforementioned Practice Note provides the definition of a medical device as: 'any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its...

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TMT weekly highlights—5 June 2025

Welcome to this week’s edition of the TMT weekly highlights: a hand-picked summary of news analysis, updates and new content from across the technology, media and telecoms sectors. These highlights focus on key topics including new technologies, software, cloud computing, internet, outsourcing, music, film & television, publishing, defamation and telecoms.

International Trade weekly highlights—5 June 2025

This week's edition of International Trade weekly highlights includes: the EU moving to curb Chinese access to public procurement medical device contracts, Subsidy Control (Subsidy Database Information Requirements) (Amendment) Regulations 2025, the Trade Remedies Authority proposing a five-year extension of India Polyethylene Terephthalate countervailing duties in a transition review, and weekly roundups of HMRC import, export and customs guidance.