Dear Valued Partners & Distributors,
We are writing to formally update you on the critical timeline changes of EU medical device certification, the current industry status of MDR certification application, as well as our company’s comprehensive qualification advantages, to help you reasonably arrange product registration, market sales and business layout in advance.
As is well known, all CE MDD certificates globally for high-risk medical devices will expire on December 31, 2027; this is a mandatory regulatory deadline stipulated by the EU. After this date, if a company fails to obtain a valid EU MDR certificate, it will be unable to meet the official registration requirements of the EU and related overseas countries. This will directly lead to obstructed market access, interrupted sales qualifications, and irreparable business losses—the impact is particularly severe for countries with long product registration cycles. Therefore, preparing sufficient registration materials in advance is crucial to ensuring a seamless transition in marketing and sales.
Given the saturation of auditing capacity and stringent review standards, completing a new EU MDR certification application typically takes at least 2 to 3 years. Many companies in the industry are stuck in the audit queue and may not be able to obtain a valid MDR certificate before the 2027 deadline, meaning their products face the risk of being withdrawn from the European and global markets.
Faced with such a challenging industry environment, we are honored to emphasize our core competitive advantage to all our new and existing partners:
Our company has already successfully obtained a complete and valid standard CE MDD certificate. To my knowledge, no more than five companies have obtained this certificate so far, and we are fortunate to be one of them. We have already obtained FDA certification in the United States, including the registration certificate and serial number. Furthermore, we have also obtained ISO certification, Free Sale Certificate, and Declaration of Conformity.
To effectively manage business risks and plan your market strategy, we recommend that you review your product registration progress as soon as possible and prioritize cooperation with qualified suppliers who have advantages in the MDR certification process to mitigate market risks arising from supplier certificate expiration.
We sincerely hope to maintain a long-term, mutually beneficial relationship with all partners and, with our reliable qualifications and forward-looking strategy, help you solidify your market share and mitigate regulatory risks.
Best regards,
Foshan Adelson
Guangdong Yadeng Medical
