Compliance & Regulations

MHRA – Medicines and Healthcare products Regulatory Agency

The MHRA is the UK’s national authority responsible for regulating medicines, medical devices, and blood components for transfusion. It plays a central role in ensuring that medical products meet applicable standards of safety, quality, and efficacy before and after they reach the UK market.

The MHRA is an executive agency of the UK Government, operating under the Department of Health and Social Care (DHSC). It oversees the registration, conformity assessment, post-market surveillance (PMS), and incident reporting for medical devices in Great Britain (England, Scotland, and Wales).

LifeVac, in its ongoing commitment to safety and regulatory compliance, continuously reviews its clinical evaluation and ensures that its post-market surveillance activities are kept fully up to date. These documents remain available to all regulatory authorities upon request. Additionally, continuous monitoring, regular risk management reviews, and the integration of feedback from users and regulatory bodies help ensure that the device remains safe and effective.

All of this outlines the rationale, the clinical advantages over existing treatment methods, and most importantly the safety profile, which LifeVac has already demonstrated to numerous regulatory authorities worldwide.

Post-Market Surveillance

In both the United Kingdom and the European Union, manufacturers of Class I medical devices are required to implement a Post-Market Surveillance (PMS) system in accordance with the UK Medical Devices Regulations 2002 (as amended) and the EU Medical Device Regulation (EU MDR 2017/745). These systems are designed to ensure ongoing monitoring of device safety, performance, and compliance once the product is placed on the market.

LifeVac established a comprehensive PMS process prior to market deployment, in line with regulatory expectations in both jurisdictions. This includes vigilance procedures to detect, assess, and respond to adverse events, use errors, and emerging risks, as well as to determine whether corrective or preventive actions are required.

The PMS system includes structured data collection following each use of the device, enabling LifeVac to systematically evaluate real-world performance. Recognising the unique nature of choking incidents, LifeVac also identified an opportunity to gather broader data beyond standard PMS requirements. This has led to the publication of multiple peer-reviewed, independent medical studies documenting lives saved, assessing safety and effectiveness, and comparing LifeVac to traditional methods and other airway clearance devices (ACDs).

These studies consistently demonstrate LifeVac’s effectiveness in emergency scenarios, reinforcing its value as a life-saving intervention and supporting its continued compliance with both UK and EU regulatory frameworks.

UKCA & CE Marking

LifeVac Europe Ltd. is both UKCA and CE marked. This means, as a Class I medical device we are fully compliant to all relevant regulatory requirements under UK MDR 2002 and EU MDR 2017/745.

This gives our customers  the peace of mind that their LifeVac Airway Clearance Device (ACD) is regulated and safe to use in the event of a choking emergency.

Additionally, here at LifeVac every manufactured device goes through a strict quality control inspection process, in accordance with our fully document manufacturing procedures.

CLASS I

The LifeVac ACD is a Class I medical device as defined in Part II of the UK Medical Devices Regulations 2002 (SI 2002 No. 618), in accordance with the classification rules set out in Annex IX (as modified by Part II of Schedule 2A to those Regulations).

UK MDR 2002 & EU MDR 2017/745

In the UK, the Medical Devices Regulations 2002 (UK MDR 2002, as amended following the UK’s departure from the EU), form the basis of national regulation. These regulations have evolved independently from the EU framework. LifeVac continues to meet all applicable requirements under the UK MDR and remains compliant with current UK regulatory obligations.

The EU Medical Device Regulation (EU MDR 2017/745) was established to harmonise medical device laws across EU member states, ensuring high standards of safety and performance. LifeVac remains fully compliant with the EU MDR and all applicable EU regulations governing medical devices.