In vitro diagnostic medical device manufacturers will soon be expected to comply with major changes in the European Union’s (EU) long-standing regulatory framework which governs market access to the EU.
After intensive discussions and negotiations between Parliament, the Council and the Commission, the EU Regulation 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices (IVDR) was finally approved on 5 April 2017, published in the official Journal of the EU on 5 May 2017, and entered into force on 26 May 2017.
The new In vitro diagnostic medical device regulation (IVDR) 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 proposed regulation include:
The IVDR was officially published on 5 May 2017 and entered into force on 26 May 2017. Manufacturers of currently approved medical devices will have a transition time of five years until 26 May 2022 to meet the requirements of the IVDR. Under certain conditions, products already certified by a Notified Body might be placed on the market for additional 2 years. It is important to note that, as an EU regulation, the IVDR will have the force of law throughout the EU when it comes into effect. This approach should eliminate country by country interpretations of the requirements permitted under current directives.
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.
TÜV SÜD Product Service is closely evaluating the developments related to the IVDR, and will provide in the coming months, resources for medical devices manufacturers to help them stay informed about the anticipated changes and prepare for the transition.
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 prepared and working closely with the Authorities to get notification 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 after the new regulations take effect.