Be confident of medical device market approval in the European Union
Medical device manufacturers will soon be confronted with major changes in the EU's decades-old regulatory framework, which governs market access to the European Union (EU). The MDR will replace the EU's current Medical Device Directive (93/42/EEC) and the EU's Active Implantable Medical Devices Directive (90/385/EEC).
The Medical Device Regulation was officially published on May 5, 2017 and came into force on May 25, 2017. Manufacturers of currently approved medical devices will have a transition time of three years until May 26, 2020 to meet the requirements of the regulation. For some manufacturers, the new EU MDR provides additional time after the date of application, allowing them to place new products for a maximum of 4 more years on the market. More requirements will apply for this extended transition period. Click here to access the published MDR on the Official Journal of the European Union. The corrigenda for the MDR and IVDR have also been made public in this official journal.
The new EU MDR imposes strict demands on medical device manufacturers and the Notified Bodies whom they must involve in the approval process of medical devices other than self-declaration class I devices.
TÜV SÜD Product Service is among the world's first certification bodies to receive designation as a Notified Body for the new Medical Device Regulation by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG).
With more than 750 medical device professionals in more than 30 locations worldwide, we are the largest EU Notified Body globally authorized to provide certification services under the new regulation.
The EU MDR differs in several important ways from the EU’s current directives for medical devices and active implantable medical devices. The most significant changes in the regulation include:
The complex development process for most types of medical devices, combined with the need to address new regulatory requirements and obtain Notified Body approval, is likely to make the transition a complicated and time consuming process for most device manufacturers. Further, currently approved devices are not exempt from the requirements of the new regulation and will need to be re-evaluated and re-approved.
As manufacturers need to apply for an applicable conformity assessment procedure based on their product classification, a step by step information guide on each of the procedures is provided here.
Since a large number of medical devices will now require Notified Body review and approval, delays in the review and approval process by Notified Body should be expected. Therefore, it is recommended that manufacturers of currently approved devices consult with their respective Notified Body to evaluate potential compliance issues and to develop a plan to address them promptly. Advanced preparation and early action will be key to ensuring a smooth transition to the new requirements.
Understand the new regulation aesthetic manufacturers must follow and the steps to achieve compliance
Comply with MDR Article 117
Learn the need and requirements for single fault safety
Understand the requirements outlined in Annex II and the elements that need to be included in the Technical Documentation
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