IVD Regulations

In vitro diagnostic devices subject to significant changes under proposed regulation

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 (IVD) 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).

Key changes

The proposed IVDR differs in several important ways from the EU’s current directive. The most significant changes in the proposed IVD regulation include:

Product scope expansion - The scope of in vitro devices covered under the regulation will be significantly expanded to include 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 will impose 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 IVDs according to their level of risk instead of lists.
Identification of 'a person responsible for regulatory compliance' - Device manufacturers will be 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 will likely require the involvement of a Notified Body for the approval of all but Class A devices. As a result, it is expected that more than 70 percent of all IVDs will now 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 will be considerably tightened.
Implementation of unique device identification - The proposed regulation mandates the use of unique device identification (UDI) mechanisms. This requirement is expected to increase the ability of manufacturers to trace specific devices through the supply chain, and to facilitate the prompt and efficient recall of IVDs 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 will be reasonably increased. The IVDR will require device manufacturers to conduct clinical performance studies and provide evidence of safety and performance proportionate with a device’s assigned risk class. Device manufacturers will also be required 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 may 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 may 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 will have five years to demonstrate compliance with the IVDR's new requirements.

Regulation timeline

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.

How To 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.

TÜV SÜD's Services

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.