PDI International, a manufacturer of innovative and sustainable infection control solutions, has announced 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).
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."
