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In vitro diagnostic medical device manufacturers will soon have to comply with major changes in the European Union’s (EU) long-standing regulatory framework which governs market access to the EU.
EU Regulation 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices (IVDR) was published in the official Journal of the EU on 5 May 2017, and entered into force on 26 May 2017. It will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC).
The proposed IVDR differs in several important ways from the EU’s current directive on in vitro diagnostic 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.
Although the IVDR entered into force, several amendments may apply via Implementing and Delegated Acts which are stipulated in the text of the regulation. IVD device manufacturers are well-advised to stay current regarding amendments of the IVDR by these acts.
The complex development process for most types of in vitro diagnostic medical devices, combined with the need to address new regulatory requirements and obtain Notified Body approval for a reasonably increased number of products, is making the transition a complicated and time-consuming process for device manufacturers. Further, currently approved devices are not exempted from the requirements of the new Regulation and will need to be re-evaluated and re-approved.
In addition, since most IVD devices will now require Notified Body review and approval, potential delays in the review and approval process by Notified Body should be considered. Therefore, it is recommended that manufacturers consult with their respective Notified Body to evaluate potential issues related to currently approved devices and to develop a plan to address them promptly. Advanced preparation and early action will be critical in ensuring a smooth transition to the new requirements.
Although the text of the IVDR is approved, several amendments may apply via Implementing and Delegated Acts which are stipulated in the text of the regulation. IVD device manufacturers are well-advised to stay current regarding amendments of the IVDR by these acts.
The complex development process for most types of in vitro diagnostic medical devices, combined with the need to address new regulatory requirements and obtain Notified Body approval for a reasonably increased number of products, is likely to make the transition a complicated and time-consuming process for most device manufacturers. Further, currently approved devices are not exempted from the requirements of the new Regulation and will need to be re-evaluated and re-approved.
In addition, since most IVD devices will now require Notified Body review and approval, potential delays in the review and approval process by Notified Body should be considered. Therefore, it is recommended that manufacturers consult with their respective Notified Body to evaluate potential issues related to currently approved devices and to develop a plan to address them promptly. Advanced preparation and early action will be critical in ensuring a smooth transition to the new requirements.
As the world’s largest EU Notified Body for all types of medical devices covered by EU directives and regulations, TÜV SÜD Product Service is designated as a Notified Body under the new IVDR. Under the new regulations, stricter requirements will be imposed on Notified Bodies and all existing Notified Bodies will have to receive new notification. Therefore, it is essential for manufacturers to have a Notified Body who will retain their status under the new regulations take effect.
Be confident of IVD medical device market approval
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