Medical devices

Copyright © 2026 LexisNexis
This Overview guides you to core materials on medical devices within the Life Sciences practice area, explaining the regulatory framework, key processes and issues practitioners must navigate.

In Great Britain, the principal regime is the UK Medical Devices Regulations 2002 (as amended) administered by the MHRA, with UKCA/CE marking recognised under transitional arrangements. Northern Ireland applies EU rules under the Windsor Framework. Practitioners should understand device classification, conformity assessment via Approved Bodies or self‑declaration, clinical investigations, applicable labelling and information requirements, and the roles of manufacturers, authorised representatives, importers and distributors.

Post‑market obligations are central: vigilance and reporting of serious incidents and field safety corrective actions, post‑market surveillance planning, device identification and traceability, and recall coordination. Borderline determinations (for example, devices–medicines, cosmetics or IVDs), software as a medical device and AI‑enabled functionality merit assessment; the MHRA’s Software and AI as a Medical Device Change Programme and guidance remain important references. Advertising and claims substantiation engage the UK MDR, consumer protection law and the CAP Code.

The Overview also highlights EU MDR/IVDR requirements relevant to cross‑border supply and Northern Ireland, product liability considerations, data protection for devices, procurement and market...

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

Existing user? Sign-in TAKE A FREE TRIAL
Powered by Lexis+®
Latest Life Sciences News

EMA launches pilot of revised pre-submission interactions model for marketing authorisation applications

The European Medicines Agency (EMA) has launched an 18-month voluntary pilot of a revised pre-submission interactions (PSI) model for initial...

The interpretation of the SPC manufacturing waiver reaches the CJEU—preliminary ruling in case c-371/26

Life Sciences analysis: The request for a preliminary ruling that gave rise to Case C-371/26 was made in the context of proceedings before the Danish...

EAHP and EFPIA publish joint guidance on single unit barcoding for medicines

The European Association of Hospital Pharmacists (EAHP) and the European Federation of Pharmaceutical Industries & Associations (EFPIA) have published...

MHRA updates NICE real-world evidence dialogue programme with cycle dates

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its MHRA-NICE Real-World Evidence Scientific Dialogue programme to add...

View Life Sciences by content type :  
News
Practice notes
Precedents
Q&As

Popular documents

If a rentcharge is shown as being informally exonerated on title information, does this apply to the

If a rentcharge is shown as being informally exonerated on title information, does this apply to the current registered owner? Or does the informal exoneration only apply to the parties to the document which informally exonerated the rentcharge?This Q&A considers the situation where, at some point

Strike out—making an application to strike out a statement of case

Strike out—making an application to strike out a statement of caseA strike out order can be made either following an application by the parties or on the court's own initiative. This Practice Note deals with the scenario of the order being made following a party's application.Making an application

Contributory negligence in personal injury claims

Contributory negligence in personal injury claimsContributory negligence is a partial defence which can lead to a discount in damages.Other defences may also be relevant. See Practice Notes: Did the claimant consent to the risk of injury? and Was the claimant involved in an illegal activity?If a

Glossary—Latin legal terms

Glossary—Latin legal termsDespite attempts in recent years to simplify the language used in legal cases, there are still a number of Latin phrases commonly used in personal injury claims. The following Latin phrases are listed in alphabetical order:Latin termDefinitionMeaningActa iure imperiiLegal
If a rentcharge is shown as being informally exonerated on title information, does this apply to the

If a rentcharge is shown as being informally exonerated on title information, does this apply to the

If a rentcharge is shown as being informally exonerated on title information, does this apply to the current registered owner? Or does the informal exoneration only apply to the parties to the document which informally exonerated the rentcharge?This Q&A considers the situation where, at some point

Strike out—making an application to strike out a statement of case

Strike out—making an application to strike out a statement of case

Strike out—making an application to strike out a statement of caseA strike out order can be made either following an application by the parties or on the court's own initiative. This Practice Note deals with the scenario of the order being made following a party's application.Making an application

Contributory negligence in personal injury claims

Contributory negligence in personal injury claims

Contributory negligence in personal injury claimsContributory negligence is a partial defence which can lead to a discount in damages.Other defences may also be relevant. See Practice Notes: Did the claimant consent to the risk of injury? and Was the claimant involved in an illegal activity?If a

Glossary—Latin legal terms

Glossary—Latin legal terms

Glossary—Latin legal termsDespite attempts in recent years to simplify the language used in legal cases, there are still a number of Latin phrases commonly used in personal injury claims. The following Latin phrases are listed in alphabetical order:Latin termDefinitionMeaningActa iure imperiiLegal