Notified Bodies are allowed to apply first-time since November 26, 2017 for designation under the Medical Device Regulation (MDR) 2017/745. We are glad to inform you, that our application is already filed and covers a comparable scope as currently maintained by us.
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Manufacturers of medical devices are facing new requirements with MDR 2017/745, which took effect May 25, 2017 with an application date of May 26, 2020. During the transition period, medical device manufacturers must plan, prepare and implement strategies for compliance, as this regulation is a prerequisite for access to European markets.
Our solid track record in the field of medical devices is underpinned by our solid reliability and extensive expertise. As a well established Notified Body, we have actively verified compliance under the Medical Device Directive 93/42/EEC (MDD) and the Active Implantable Medical Device Directive 90/385/EEC (AIMDD), both of which are now being replaced by the new regulation. Our capacity and competence in the field is already in place and we look forward to sharing our knowledge with existing clients and new partners alike.
With our experience and solid status as a Notified Body under current legislation governing medical devices, we are perfectly positioned to support you in the transition to the new regulation .
Contact us to learn more about the specifics and timing of MDR 2017/745 and how it affects your business.
With the replacement by MDR 2017/745 of existing rules governing medical devices in the EU, manufacturers will soon be required to reassess their products for compliance. An MDR conformity assessment procedure provides companies the chance of achieving the necessary certification required to place products on the European market. Compliance access, your prerequisite for regulatory success.
On your path to compliance we can inform and ultimately carry out any necessary technical documentation review and auditing. We are backed by a global network of industry experienced specialists and facilities and offer a one-stop shop of medical device-related services.
Currently, our services focus on the transition period and the timeline for compliance with MDR 2017/745. Our experts can assist you in meeting deadlines and addressing all issues relevant to maintaining access for your medical devices to European markets.
As a test house and specialist for market access throughout the world, we offer the medical device industry comprehensive services all under one roof. In addition to enabling you to navigate the transition to compliance with the new European Medical Device Regulation, our services include QM system auditing for medical device manufacturers, suppliers and sales offices as well as medical device testing. We are innovative and prepared for future topics in the area of digitalization, such as wireless connections, telemedicine, medical apps, cyber security, personal data protection, and more.
Ask our experts to get an early start on MDR compliance. Make an appointment today.
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