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PPE Authorised Representative

PPE (Personal Protective Equipment) regulations are comprehensive frameworks designed to ensure the safety, quality, and efficacy of PPE products while safeguarding consumers.

PPE Regulations

The European Union (EU) and the United Kingdom (UK) have established stringent regulations to ensure the safety and performance of Personal Protective Equipment (PPE).

EU

In the EU, PPE is regulated under Regulation (EU) 2016/425, which outlines the essential health and safety requirements (EHSR) for design, manufacturing, and marketing of PPE. Products must undergo conformity assessments and bear the CE marking to demonstrate compliance. The regulation covers all types of PPE, from simple protection (e.g., gloves) to more complex equipment protecting against life-threatening risks (e.g., respirators).

UK

In the UK, the regulation is now governed by the Personal Protective Equipment (Enforcement) Regulations 2018, which requires PPE sold in the UK to carry the UKCA (UK Conformity Assessed) marking post-Brexit. While the technical requirements remain largely aligned between the EU and UK, the main difference is in the labeling and conformity marking. Both markets mandate that the PPE products meet rigorous testing standards, undergo third-party certification for high-risk equipment, and ensure proper documentation, such as the technical file and Declaration of Conformity, are in place for market entry.

EU Authorised Representative Role

An EU PPE Authorised Representative (AR) plays a crucial role for non-EU manufacturers who wish to market Personal Protective Equipment (PPE) within the European Union. The AR acts as the manufacturer’s legal liaison within the EU, ensuring that the PPE complies with Regulation (EU) 2016/425 and meets all necessary safety and performance standards. This representative is responsible for maintaining and making available the product’s technical file, including test reports, risk assessments, and the Declaration of Conformity, to the relevant authorities. The AR also assists in managing regulatory communications, particularly during market surveillance activities or if any issues arise with the product’s compliance. Additionally, the AR’s role includes ensuring that the correct CE marking is applied and that the product is registered where necessary. While the AR facilitates market access, the ultimate responsibility for product safety and compliance remains with the manufacturer. However, failure to appoint an AR can prevent the PPE from being legally sold in the EU market.

UK Authorised Representative Role

A UK PPE Authorised Representative (UK AR) is essential for non-UK manufacturers who want to sell Personal Protective Equipment (PPE) in the UK. Following Brexit, the UK introduced its own conformity assessment system, and PPE sold in the UK now requires the UKCA (UK Conformity Assessed) marking. The UK AR acts as the manufacturer’s legal entity within the UK, ensuring compliance with the Personal Protective Equipment (Enforcement) Regulations 2018. Their responsibilities include holding and maintaining the technical documentation, such as the technical file, risk assessments, and the Declaration of Conformity, to demonstrate that the PPE meets UK regulatory standards. The UK AR also facilitates communication between the manufacturer and UK enforcement authorities, ensuring that any issues with compliance are addressed promptly. Additionally, they are responsible for making sure the correct UKCA marking is applied to the product. While the manufacturer is ultimately responsible for product safety, appointing a UK AR is a legal requirement for non-UK manufacturers to access the UK market.

Patient Guard

Patient Guard, as a regulatory consultancy with offices in both the UK and EU, is uniquely positioned to serve as a PPE Authorised Representative (AR) for manufacturers looking to enter these markets. Acting as a customer’s AR, Patient Guard ensures that products, such as Personal Protective Equipment (PPE), comply with relevant regulations, including Regulation (EU) 2016/425 in the EU and the Personal Protective Equipment (Enforcement) Regulations 2018 in the UK. With local expertise in both regulatory frameworks, Patient Guard can manage all aspects of compliance, including maintaining technical files, facilitating communication with market surveillance authorities, and ensuring correct CE and UKCA markings are applied. By offering representation in both regions, Patient Guard simplifies the process for manufacturers, providing a seamless route to market access while ensuring full regulatory compliance in both jurisdictions.

The Benefits of using Patient Guard

Here are the benefits of using Patient Guard as a regulatory partner:

Expertise: In-depth knowledge of both UK and EU regulatory landscapes, ensuring compliance with complex standards.
Qualified professionals: A team of highly qualified experts who specialize in regulatory compliance for products like PPE.
Well-established: Operating since 2017, with a proven track record of helping clients achieve market compliance.
Cost-effective solutions: Offering affordable services that allow manufacturers to access top-tier regulatory support without excessive costs.
Diligent approach: Ensuring that all technical documentation, risk assessments, and conformity processes are handled meticulously to minimize the risk of non-compliance.
Dual presence: Offices in both the UK and EU, providing seamless support for clients needing compliance in both regions.

This comprehensive approach makes Patient Guard a reliable partner for manufacturers entering these regulated markets.

Our Track Record

Patient Guard has an impressive track record, having successfully worked with over 400 customers since its inception in 2017. This extensive experience has enabled the consultancy to develop a deep understanding of the diverse regulatory challenges that manufacturers face when bringing products to market in the UK and EU. By providing tailored, expert advice and comprehensive support, Patient Guard has helped a wide range of businesses achieve compliance with local regulations, including those governing Personal Protective Equipment (PPE). The consultancy’s ability to manage the complexities of regulatory processes efficiently and cost-effectively has earned the trust and loyalty of clients across various industries, reinforcing its position as a leading regulatory partner.

Patient Guard have been a great support service to Cormed, providing help and advice promptly whenever requested. They have become a virtual department within Cormed enabling us to keep up to date and comply with the regulatory requirements whilst ensuring our QMS works for us at the same time.

Tracey Slater, Cormed