Be confident of medical device market approval
Be confident of medical device market approval
The IVDR is the current regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market.
It was published in the Official Journal of the EU on 5 May 2017, and entered into force on 26 May 2017, gradually replacing the EU’s former Directive on in vitro diagnostic medical devices (98/79/EC).
As a European regulation, it is effective in all EU member states and EFTA states immediately without need to be transferred into the law of respective states, however national laws may be adapted to back up some requirements in more detail.
Under Regulation EU 2023/607, the ‘sell off’ dates in article 110(4) of the IVDR are removed. This allows in vitro diagnostic medical devices which are already placed on the market, to remain on the market without having to be disposed of. This can only be done if the devices were originally compliant to previous legal requirements under In Vitro Diagnostic Directive (IVDD).
The transition period depends on the class of the IVD device under the current Directive and Regulation 2017/746 as well as additional conditions available below in the next section:
See graph below for a summary of the timeline of Regulation 2022/112 on IVDR Transitional Provisions.
The additional conditions are that no significant changes to the device design and intended purpose are done and the device continues to meet the requirement of the IVD Directive as per IVDR article 110(3).
However, some requirements of the IVDR (e.g. post-market surveillance, vigilance, registration of economical operators, market surveillance) will apply from IVDR DoA as per article 110 (3).
See below for a summary of conditions necessary to benefit from the transitional measures.
Although the IVDR Date of Application has passed, implementing and delegated acts as well as guidance documents are still being published. IVD device manufacturers are well-advised to stay current regarding the publication of these acts and guidance documents.
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, and ensure a smooth transition to the IVDR requirements.
As one of 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 IVDR. Under the regulations, stricter requirements are imposed on Notified Bodies and all existing Notified Bodies have to receive new notification. Therefore, it is essential for manufacturers to have a Notified Body who will retain their status under the regulation.
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, previously 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.
The purpose of a structured dialogue prior to lodging a formal IVDR application with TÜV SÜD is to clarify the timing, procedural, and regulatory aspects of the application process and forms, and the submission documents.
These structured dialogues are limited to meetings with clients before the application for a conformity assessment and are independent of the assessment. Therefore, and to show the utmost intention of being independent, impartial, and objective, the structured dialogue service shall be ordered independently from the IVDR framework agreement.
Expand the tabs below to find out the possible topics, process and how to apply for Structured Dialogue.
Application & Onboarding
Topics of manufacturer
Conformity Assessment Procedure
Existing clients with TÜV SÜD Notified Body:
The IVDR differs in several important ways from the EU’s previous directive on in vitro diagnostic medical devices. The most significant changes in the regulation include:
The scope of IVD devices covered under the regulation is 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.
The IVDR employs a classification structure for in vitro devices consistent with that of the Global Harmonization Task Force (GHTF). Risk classes 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.
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.
The application of the IVDR’s risk classification scheme requires the involvement of a Notified Body for the approval of all but Class A non-sterile 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.
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.
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 performance data as part of the ongoing assessment of potential safety risks.
Competent Authorities and Reference Laboratories (if designated) 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.
Under the IVDR, all in vitro diagnostic devices already approved had to be recertified in accordance with the new requirements. Manufacturers with previously approved devices had to demonstrate compliance with the IVDR’s new requirements by 26 May 2022, although under specific circumstances an extended transition period is possible for certain devices (see transitional timeline section below for more information on transition deadlines).
Placing on the market implies that the device is manufactured and sold by the Manufacturer or Importer to a different legal entity although not necessarily physically transferred. Any subsequent operation, for example, from a distributor to an end-user is defined as making available. Both placing on the market and making available on the market refer to each individual device, not to a type of device, and whether it was manufactured as an individual unit or in series.
Consequently, even though a device model or type has been supplied before the IVDR Date of Application, individual units of the same model or type, which are placed on the market after the Date of Application, must comply with the IVDR requirements.
The IVDR introduced many changes to the regulatory requirements for IVDs in the EU.
These changes will require strong investments (time, resources, budget) from Manufacturers to meet the new requirements. In addition, guidance documents, Implementing and delegated acts are still to be published. Manufacturers of in vitro diagnostic medical devices are well-advised to stay current on amendments to IVDR and work with their Notified Body to ensure a timely review and approval of their devices ahead of the IVDR Date of Application.
You can follow the TÜV SÜD LinkedIn showcase page for Healthcare & Medical Devices for the latest information.
Additional resources are available on TÜV SÜD website at in vitro diagnostic medical device regulation resources.
Guidance documents published by the Medical Device Coordination Group (MDCG) are available on the EU Commission Website.
Following the publication of regulation (EU) 2022/112, the IVDR will be rolled out gradually.
A quick guide to the IVDR and what to expect
Stay updated on the requirements for devices that were already on the market under IVDD and learn how to transition into IVDR.