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We are excited to announce that Med-Di-Dia has expanded its service offerings to include the role of EU Responsible Person, helping non-EU manufacturers comply with the General Product Safety Regulation (GPSR), which comes into effect on 13 December 2024.

 

As a trusted EU Authorised Representative (EU AR) for the medical industry, we have a proven track record of delivering regulatory support for time-critical services. Our expertise ensures manufacturers meet tight compliance deadlines without compromising quality or safety. Building on this foundation, our new EU Responsible Person service is tailored to help businesses confidently navigate the complexities of the GPSR and maintain uninterrupted market access.

 

Our regulatory expertise extends beyond the EU. Our services thrive in the UK as a UK Responsible Person (UK RP) and in the USA as a US Agent, delivered in partnership with Global Regulatory Services (GRS). With a proven track record of helping manufacturers navigate complex regulatory landscapes in these regions, we provide seamless support to ensure compliance, market access, and business growth across key global markets.

 

Why Appoint an EU Responsible Person Under the GPSR?

The GPSR introduces stricter requirements for consumer product safety in the EU, and non-EU manufacturers must appoint an EU-based Responsible Person. Their responsibilities include:

• Acting as the primary point of contact for EU authorities.
• Holding and maintaining technical documentation to demonstrate compliance.
• Supporting post-market surveillance to monitor product safety and address complaints.
• Managing incident reporting and coordinating product recalls when required.
• Ensuring compliance with labelling and traceability requirements under the GPSR.

Failing to appoint an EU Responsible Person by the 13 December 2024 deadline can lead to non-compliance, restricted market access, and potential legal or financial repercussions.

 

Why Choose Med-Di-Dia?

Med-Di-Dia specialises in handling time-sensitive regulatory services, making us the ideal partner for companies operating under tight deadlines. Our deep understanding of EU regulations ensures that your compliance journey is efficient and stress-free.

 

Our EU Responsible Person services include:

• Expert Guidance: Tailored support to meet GPSR obligations promptly and effectively.
• Proactive Communication: Acting as your point of contact with EU authorities to handle any inquiries or regulatory issues.
• Streamlined Documentation: Managing and maintaining technical files to ensure immediate availability during audits.
• Time-Critical Compliance: Fast-tracked processes to help you meet the 13 December 2024 deadline.
• Ongoing Support: Continuous monitoring of regulatory changes to keep your business ahead of new requirements.

Act Now – Don’t Miss the Deadline

With the GPSR deadline approaching quickly, manufacturers must act swiftly to appoint their EU Responsible Person and implement compliance measures. Early action can save valuable time and ensure uninterrupted market access.

 

📧 Contact us via email at mdd@mddltd.com or
🌐 Fill out our web form at https://med-di-dia.com/contact.php.

 

Let Med-Di-Dia’s expertise and time-critical services help you confidently meet your compliance deadlines. Partner with us today to secure your success in the EU market!