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About Life Sciences Law

Lexis®+ Life Sciences is an online practical guidance product for contentious and non-contentious lawyers providing advice to and supporting the UK’s Life Sciences sector.

Research and development

Highly regulated, with strict compliance rules, work can be in-house or in collaboration with another entity. Guidance includes practice notes on UK and EU regime for clinical trials and various precedents.

Intellectual property

Patents and supplementary protection certificates are significant to many life sciences businesses. We have practice notes on pharmaceutical patents, biotechnology patents, IP protection for medical devices and more.

Medicinal products

This content includes guidance on marketing authorisations, orphan and paediatric medicines, pharmacovigilance, manufacturing, unlicensed and off-label medicines.

Medical devices

Covering key areas of medical devices regulation including classification, conformity assessments, clinical and performance evaluation as well as post-market surveillance.

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Associated legal terms

Active device (or active medical device)

Generally, active devices refer to medical devices powered by electricity or any source of power other than that generated by the human body or gravity. Examples are examination lights, surgical microscopes, gas pressure regulators or blood pumps for heart-lung machines or devices for viewing diagnostic images such as ultrasound images. Under Regulation (EU) 2017/745 (EU MDR), ‘active device means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device’. UK legislation compounds the definition of an ‘active’ device with implantable devices.

Bioequivalence

Two medicinal products containing the same active substance are considered bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and their bioavailabilities (rate and extent) after administration in the same molar dose lie within acceptable predefined limits.

In-vitro diagnostic medical device

Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in-vitro for the examination of specimens derived from the human body.
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