In vitro diagnostic devices subject to significant changes
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).
Key changes
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:
- Product scope expansion - The scope of IVD devices covered under the regulation will be significantly expanded to include among others high-risk devices manufactured for use within a single healthcare institution, as well as diagnostic (including internet based) services, genetic testing and other test that provide information about a patient’s predisposition for a specific disease or for susceptibility for a medical treatment.
- Re-classification of devices - The IVDR employs a classification structure for in vitro devices consistent with that of the Global Harmonization Task Force (GHTF). Risk classes will range from Class A for low risk devices to Class D for those devices that pose the greatest risk to patients and the public. The Regulation provides specific rules for properly classifying IVD devices according to their level of risk instead of lists.
- Identification of 'a person responsible for regulatory compliance' - Device manufacturers are required to identify at least one person within their organisation who is ultimately responsible for all aspects of compliance with the requirements of the new Regulation. The organisation must document the specific qualifications of this individual relative to the required tasks.
- Increased Notified Body involvement - The application of the IVDR’s risk classification scheme requires the involvement of a Notified Body for the approval of all but Class A devices. As a result, approx. 90 percent of all IVD devices will be subject to Notified Body review, compared with less than 15 percent currently. Concurrently, the requirements for designation and monitoring of Notified Bodies under IVDR are considerably tightened.
- Implementation of unique device identification - The regulation mandates the use of unique device identification (UDI) mechanisms. This requirement increases the ability of manufacturers to trace specific devices through the supply chain, and to facilitate the prompt and efficient recall of IVD devices that have been found to present a safety risk.
- More stringent requirements regarding technical documentation and clinical evidence - The level of detail regarding the contents of the technical documentation is increasing substantially. The IVDR requires device manufacturers to conduct clinical performance studies and provide evidence of safety and performance proportionate with a device’s assigned risk class. Device manufacturers have to collect and retain post-market clinical data as part of the ongoing assessment of potential safety risks.
- Greater Scrutiny of Notified Bodies – Competent Authorities and Reference Laboratories have to be involved in conformity assessment of high risk devices which will result in elongated conformity assessment procedures. Tighter designation rules for Notified Bodies lead to a reduced number of Notified Bodies available.
- No "grandfathering" provisions – Under the IVDR, all currently approved in vitro diagnostic devices must be recertified in accordance with the new requirements. Manufacturers with currently approved devices have to demonstrate compliance with the IVDR’s new requirements by 26 May 2022.
CONFORMITY ASSESSMENT PROCEDURES
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.
TRANSITION timeline
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.
How can you prepare?
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.
How can TÜV SÜD help you?
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.
Frequently asked questions on IVDR
