The following Life Sciences practice note Produced in partnership with Reuben E Jacob and Dr Edward Rainsford provides comprehensive and up to date legal information covering:
On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a Member State for many purposes. As a third country, the UK can no longer participate in the EU’s political institutions, agencies, offices, bodies (except to the limited extent agreed), but it continues to be subject to EU law and must submit to the continuing jurisdiction of the Court of Justice of the EU in accordance with the transitional arrangements in Part 4 of the Withdrawal Agreement. For further reading, see: Brexit—Life Sciences and News Analysis: Brexit Bulletin—key updates, research tips and resources.
‘Medical device’ is a broad term that covers a wide range of products involved in human or animal health and encompasses very simple devices, such as tongue depressors, to complex products, such as pacemakers.
The Medical Devices Regulations 2002, SI 2002/618 (as amended) define a medical device as:
‘an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which is intended by the manufacturer to be used for human beings for the purpose of:•diagnosis, prevention, monitoring, treatment or alleviation of disease,•diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,•investigation, replacement or modification
‘an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which is intended by the manufacturer to be used for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
investigation, replacement or modification
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Tipping off and prejudicing an investigationIt would undermine the benefit to the authorities if, a suspicious activity report (SAR) having been made, the alleged offender were to be made aware of the interest in their activities so that they could take steps to cover up their misdeeds or disappear.
ContractWhere a contract is made by two or more parties it may contain a promise or obligation made by two or more of those parties. Any such promise may be:•joint•several, or•joint and severalWhether an undertaking is joint, several, or joint and several in contract is a question of construction
You may apply simplified customer due diligence (SDD) measures in relation to particular business relationships or transactions which you determine present a low risk of money laundering or terrorist financing, having taken into account:•your organisation-wide risk assessment—see Practice Note:
Brexit: The UK's departure from the EU on exit day ie Friday 31 January 2020 has implications for practitioners dealing with provisions in the CPR relevant to cross border matters, including CPR 5.4C (discussed below). For guidance on the impact of Brexit on the CPR, see Cross border
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