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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

Accelerated assessment

Many countries offer a regulatory pathway that will expedite the evaluation of certain medicinal products so that they reach patients faster. In the EU, the accelerated assessment procedure reduces the timeframe for the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to review a marketing authorisation (MA) application from 210 to 150 evaluation days. Applications may be eligible for accelerated assessment if the CHMP decides the product is of major interest for public health and therapeutic innovation. In the UK, the Medicines and Healthcare Regulatory Agency (MHRA) offers a 150-day assessment timeline for all high-quality new MA applications in an effort to accelerate the availability of new medicines for patients in the UK. The MHRA evaluates the application for a UK, Great Britain (England, Wales and Scotland) or Northern Ireland MA and reaches its opinion on whether to approve the licensing of new medicines within 150 days of submission of a valid application. See also: marketing authorisation (MA).

Active implantable medical device (AIMD)

Generally, active implantable medical devices (AIMDs) are powered devices (other than from the human body or gravity) that are inserted into a patient’s body partially or fully through a natural orifice or by surgical means, and are intended to remain in the patient’s body. For example, coronary pacemakers, cochlear hearing implants, infusion pumps or neurostimulators. The UK and EU legislative definitions differ and are as follows: The UK Medical Devices Regulations 2002 (MDR 2002), SI 2002/618, which implement Directive 90/385/EEC, the Active Implantable Medical Devices Directive in the UK, define AIMD as: ‘…a medical device which— • relies for its functioning on a source of electrical energy or a source of power other than that generated directly by the human body or by gravity; and • is intended to be totally or partially introduced into the human body (whether surgically or medically, including being introduced into a natural orifice) and which is intended to remain in the human body after completion of the surgical or medical procedure during which it is introduced, even if it is intended to administer a medicinal product or incorporates as an integral part a substance which, if used separately, would be a medicinal product.’ Under Regulation (EU) 2017/745, the Medical Devices Regulation (EU MDR), an active device and an implantable device are separately defined: ‘…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.’ ‘…implantable device means any device, including those that are partially or wholly absorbed, which is intended: • to be totally introduced into the human body, or • to replace an epithelial surface or the surface of the eye by clinical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device.’ Specific requirements for AIMDs are set out in Annex I of the EU MDR at Chapter 2, section 19.

Off label

The intentional use of an authorised medicinal product outside the terms of its authorisation'>marketing authorisation (e.g. for a different indication, different dose or in a different patient population). It is considered off-label use of a medical device if the device is used differently from how the manufacturer has instructed.
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