Peters Surgical, a leading manufacturer of surgical medical devices, is proud to announce that it has obtained its first EU certificates under Regulation (EU) 2017/745, also known as MDR (Medical Device Regulation). This achievement represents a major milestone for our company. In addition to proving that our products comply with the world’s most stringent regulatory requirements, it testifies to the commitment and sustained mobilization of our teams at all levels of the company over the past few years.
MDR regulation, which comes into force in May 2021, sets out the detailed requirements with which manufacturers must comply in order to obtain EU certificates. It significantly strengthens the previous regulations (Medical Device Directive) for the marketing of medical devices in the European Union, to ensure that they are safe, efficient and effective, offering maximum protection to patients and healthcare professionals.
Compliance with the MDR regulation is therefore of crucial importance to manufacturers, and few companies to date have succeeded in achieving this grail, making this achievement all the more significant.
The GMED, a renowned French Notified Body, assessed and certified our first Class III Absorbable Surgical Sutures (OPTIME®, GLACTIME®, SINUSORB® PGA and ADVANTIME®), as well as our Titanium Hemostatic Clip Appliers.
Similarly, our US entity has turned to BSI, another renowned Notified Body, for the assessment and certification of the entire VTO (Vascular Temporary Occlusion) range : Clamps, Cygnet, Bulldogs, Inserts and Enclose II.
Achieving MDR certification from these two recognized Notified Bodies is a proof of Peters Surgical’s ongoing commitment to excellence and dedication to providing patients with high-quality, reliable medical devices that make a difference.
This achievement has been made possible by the incredible hard work and determination of our teams, and we would like to express our deepest gratitude to them. Throughout this complex process, in Regulatory Affairs, Quality, R&D, Clinical Affairs, Validation, Industrialization, Production, Control, Logistics, Marketing and Sales, our employees have demonstrated perseverance and a tremendous team spirit, strengthened their ability to collaborate closely and effectively, shared their technical expertise while collectively deepening their regulatory and scientific knowledge.
All in all, no less than 2,000 hours of work by all our teams, more than 400 hours of auditing and evaluation by the Notified Bodies, and an average of 150 additional requests per file were required to achieve this prestigious goal !
We invite our customers and interested parties to find out more about our MDR-certified medical devices on our website, as our compliance process continues.
There are still products in the certification process, and we are determined to finalize our regulatory transition as quickly as possible.
We are proud of this achievement. MDR certification marks a new stage in our journey, but it is not an end in itself. Today, we are more determined than ever to maintain the highest standards of quality and innovation to improve patients’ lives, but also to advance the Medical Device Industry in terms of sustainable development by tackling the challenge of minimizing our environmental impact and acting in a socially responsible manner. We look forward to sharing our future successes.
Marie Compagnon-Riobé – Chief Sustainability and Regulatory Officer