12th August 2024

PDI International Achieves MDR Certification

PDI International, a trusted European manufacturer of innovative and ever-growing sustainable infection control solutions proudly announces its seamless transition from the Medical Device Directive (MDD 93/42/EEC) to the more stringent requirements of the Medical Device Regulation (MDR 2017/745). This significant milestone underscores PDI International’s commitment to excellence, innovation, and, above all, patient safety. The Medical […]

PDI International Achieves MDR Certification

PDI International, a trusted European manufacturer of innovative and ever-growing sustainable infection control solutions proudly announces its seamless transition from the Medical Device Directive (MDD 93/42/EEC) to the more stringent requirements of the Medical Device Regulation (MDR 2017/745).

This significant milestone underscores PDI International’s commitment to excellence, innovation, and, above all, patient safety.

The Medical Device Regulation (MDR 2017/745), which came into full effect in May 2021, is a new set of regulations that governs the production and distribution of medical devices in Europe.  Compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.

These regulations are designed to enhance patient safety and provide greater transparency and traceability throughout the entire lifecycle of medical devices. By adhering to the MDR standards, PDI International is proactively addressing evolving regulatory landscapes and ensuring compliance with the most stringent safety and quality standards.

“PDI International’s transition to the Medical Device Regulation marks a significant milestone in ensuring the highest standards of patient safety and product quality,” said Chris Hill, RA/QA/NPD Director at PDI International. “Since 2019, many stakeholders, including regulatory, quality, and marketing teams, have worked tirelessly to ensure a seamless transition. I want to take this opportunity to thank them for their dedication in getting us over the line within the required timeline.  We look forward to future opportunities and challenges, confident in navigating the evolving regulatory landscape while maintaining our commitment to excellence.”

The transition to MDR brings several key benefits for PDI International and its stakeholders:

Enhanced Patient Safety: By adhering to more stringent regulatory requirements, PDI International is further strengthening the safety and efficacy of its infection control solutions, ultimately improving patient outcomes and well-being.

Greater Transparency and Traceability: The MDR mandates comprehensive documentation, traceability, and post-market surveillance, enabling PDI International to guarantee greater transparency and accountability throughout the entire lifecycle of its medical devices.

Global Market Access: Compliance with the MDR not only ensures market access within the European Union and the UK  but also strengthens PDI International’s position in global markets by demonstrating its commitment to the highest quality and safety standards.

Continued Innovation: The transition to MDR has further stimulated a culture of continuous improvement and innovation within PDI International, driving the development of sustainable technologies that meet or exceed regulatory requirements whilst supporting carbon net zero goals.

David Gueundjian, President and CEO of PDI International added: “We are proud to be the first company in our field to achieve MDR certification, as this reflects our commitment to delivering innovation with agility.  This milestone opens the door for us to now share our latest product initiatives, which meet the evolving needs of the healthcare industry, the people we serve, and the environment while ensuring patient safety remains at the forefront of everything we do. We are excited about the opportunities this certification brings and look forward to continuing our mission to provide sustainable and cutting-edge solutions that enhance patient care and safety.”

More Articles

PDI International Celebrates 5th Annual Be the Difference Day® with Community Support in the UK and Italy
Corporate

PDI International Celebrates 5th Annual Be the Difference Day® with Community Support in the UK and Italy

PDI International, a global leader in infection prevention and control solutions, proudly marked its 5th annual Be the Difference Day® [...]

Driving Positive Change: PDI International Earns Bronze Level Social Value Accreditation
Corporate

Driving Positive Change: PDI International Earns Bronze Level Social Value Accreditation

PDI International is proud to announce it has been awarded the Social Value Bronze Quality Mark®, in recognition of its [...]

PDI International Receives FSC® Trademark Approval for FSC-Certified (FSC-C212093) Products
Press Release

PDI International Receives FSC® Trademark Approval for FSC-Certified (FSC-C212093) Products

PDI International is proud to announce that it has received official approval to use the Forest Stewardship Council® (FSC®) trademark [...]

PDI International launches ground-breaking sustainable sanitising wipes for UK hospitality industry
Sani Professional

PDI International launches ground-breaking sustainable sanitising wipes for UK hospitality industry

PDI International, renowned leaders in delivering clinically proven infection prevention solutions, have launched an innovative range of biodegradable sanitising wipes [...]

Thank you for visiting .

We notice that you are visiting us from . This site only services -based visitors. Would you like to visit the site that is appropriate for your location?

*By selecting “yes” we will redirect you to and remember your choice for future visits.