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.
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 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.
Following the publication of Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022, the transition period depends on the class of the IVD device under the current Directive and future Regulation as well as additional conditions:
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.
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.