19 September 2019
TÜV SÜD Product Service has issued their first Medical Device Regulation (MDR) certificate since receiving notification in May 2019. The MDR which came into force in May 2017, must be implemented by late May 2020.
The new Medical Device Regulation (MDR, EU 2017/745) of the European Union replaces Directives 93/42/EEC on medical devices (MDD) and 90/385/EEC on active implantable medical devices (AIMDD). It is a significant regulation change which imposes stricter demands on medical device manufacturers and notified bodies. To date, 4 of the 41 notified bodies who have applied for designation under MDR have received designation and are published on the NANDO webpage.
TÜV SÜD is pleased to announce that the first TÜV SÜD MDR certificate has been issued, a certificate for a Class III (high risk) device.
“Since receiving designation and notification, TÜV SÜD has been working hard on shifting and preparing resources to provide services under the new legislative framework. We have had and continue to clarify open questions and implement newly published information about the MDR into our processes. The release of our first MDR certificate is a significant milestone. The challenge now lies in balancing our existing MDD and AIMDD projects with the strong demand for MDR services in this transition period”, says Dr Royth von Hahn, Senior Vice President / Global Head of Medical & Health Services (MHS) at TÜV SÜD Product Service.
"We take our responsibility as a designated notified body very seriously and make every possible effort to support a smooth implementation of the regulation and avoid any negative impact on the European healthcare system. It is critical that a continued supply of safe and effective medical devices is available for patients”, adds Dr Bassil Akra, Vice President, Global Strategic Business Development of Medical & Health Services (MHS) at TÜV SÜD Product Service.
TÜV SÜD is one of the world's leading notified bodies providing conformity assessment services related to medical devices. Its 750-plus medical device professionals can be found at more than 30 locations throughout the world. Manufacturers benefit from both TÜV SÜD's technical expertise and its extensive international accreditations and recognitions, including NRTL, INMETRO and the Medical Device Single Audit Program (MDSAP). These benefits considerably reduce the efforts involved in accessing international markets and time to market.
Further information about the EU Medical Device Regulation, the key changes it involves and TÜV SÜD's services in this context can be found at https://www.tuv-sud.com/mdr.
Press-contact: Dirk Moser-Delarami
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Bosnia and Herzegovina