Résultats de recherche
Le MDR (Medical Device Regulation (EU 2017/745)) remplace la MDD (Medical Device Directive (93/42/EWG)) à partir du 26 mai 2021. Beurer informe ses distributeurs sur les obligations et les étapes de la mise en oeuvre du MDR pour les dispositifs médicaux.
Soyez certifiés selon le règlement MDR (EU) 2017/745 avec DQS France : Approbation des dispositifs médicaux pour la vente ou la distribution en Europe.
22 mai 2024 · Téléchargez notre guide des meilleures pratiques MDR pour vous aider à préparer et à structurer votre documentation technique lors de la planification de votre demande d'évaluation de conformité MDR auprès de BSI.
16 déc. 2022 · EUDAMED is the European Commission's IT system to implement the MDR and IVDR on medical devices and in vitro diagnostics. It covers actors registration, UDI/devices registration, notified bodies and certificates, and more.
- What Is The Medical Device Regulation (MDR)?
- When Did The MDR Take Effect
- How Do The Requirements in The MDR Differ from Those in The Mdd/Aimdd?
- What Are The Implications of The MDR For Medical Device Manufacturers?
- Do I Need to Recall Class I Reusable Devices to Re-Label them?
- Where Can I Get More Information About MDR?
- How Do I Prepare For The MDR?
- What Is The MDR Impact on Certification Cost?
- How to Request For TÜV Süd MDR Services?
The Medical Device Regulation (MDR) replaced the EU’s original Medical Device Directive (93/42/EEC MDD) and the EU’s Directive on active implantable medical devices (90/385/EEC AIMDD).
The EU’s MDR requirements were originally scheduled to take full effect in May 2020, providing manufacturers with a three-year transition period to bring existing medical devices into compliance with the MDR’s requirements. Due to the challenges presented by the global COVID-19 pandemic, the MDR was amended in April 2020 to extend the Date of Appli...
Notable changes include: 1. Product scope expansion—The definition of medical devices and active implantable medical devices has been significantly expanded to include devices that were not previously covered under the MDD and AIMDD. Specific examples of newly covered medical devices include those that do not have a medical intended purpose, as wel...
The complexity in developing new and advance medical devices, combined with the rigorous requirements embodied in the EU’s MDR, are likely to make the regulatory approval process challenging for many device manufacturers. Even manufacturers of medical devices that were previously approved under the MDD or the AIMDD are not exempt from the MDRs requ...
No, there is no requirement to recall Class I reusable devices which are placed on the market under the MDD before the Date of Application of the MDR. In general, devices that have been lawfully placed on the market under the MDD or the AIMDD before the MDR Date of Application can be made available and put into service until 31 December 2028, subje...
Download our guide on the expected changes of the MDR here. You can also follow the TÜV SÜD LinkedIn showcase pagefor Healthcare & Medical Devices for the latest information.
It is highly advisable to stay informed about the requirements and deadlines of the MDR. A guide on the key changes of the MDRis available here. Additionally, it is important to perform an assessment of how your current product portfolio may be impacted by the regulations.
The MDR application and the auditing and designation processes require an extensive effort on the part of Notified Bodies, creating various unexpected costs that are reflected in the pricing for relevant services. Moreover, Notified Bodies have been required to restructure their organisations and increase resources to provide relevant services, thu...
Since receiving designation and notification as a MDR Notified Body, TÜV SÜD has received a large number of requests for MDR certification. We take our responsibility as a designated Notified Body seriously and make every possible effort to support a smooth implementation of the regulation and avoid any negative impact on the European healthcare sy...
Request for a MDR service registration today. TÜV SÜD can support manufacturers seeking to certify their medical devices for compliance with the European Union’s Medical Device Regulation (MDR).
TÜV Rheinland LGA Products GmbH est votre partenaire de confiance pour la transition des directives 93/42/CEE (MDD) et 90/385/CEE (AIMDD) vers les nouvelles exigences MDR, ainsi que pour la certification de vos dispositifs médicaux sous MDR. En savoir plus sur le processus MDR.
