EU IVDR: Get your documentation ready now and stay ahead of the game!

Find helpful information in this paper, put together by our specialists, and open the regulatory gateway to Europe by complying with soon-to-be mandatory laws. Is your company ready?

In May 2017, it was announced that the Medical Device Directive (MDD), the In Vitro Diagnostic Medical Devices Directive (IVDD), and the Active Implantable Medical Device Directive (AIMD) — would be replaced by new MDR and IVDR standards in order to improve clinical safety for patients and users, standardize and harmonize information, and provide a level playing field for both healthcare professionals and manufacturers.

The MDR came into force in May 2021, and it will shortly be the turn of the In Vitro Diagnostic Regulation (IVDR) 2017/746, the new EU legislation applicable to in vitro diagnostic (IVD) medical devices that replaces the EU In Vitro Diagnostics Directive (IVDD) 98/79/EC. The new IVDR regulation, which affects the manufacturers of these devices and any party involved in the supply chain or providing related services, will become mandatory as of May 26, 2022. The length of the transition period now depends on the type of device: on 16 February 2023, the European Parliament voted to amend the transitional provisions in Regulation (EU) 2017/745 on medical devices (“MDR”) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVDR”).

The amendment, the result of pressure exerted by the medical device sector and member states, will not introduce substantive revisions to the quality, safety, and performance requirements established in the MDR and the IVDR. However, it will give manufacturers some additional time to comply with the Regulations and will take some of the pressure off notified bodies, which are conducting conformity assessments in accordance with the regulations.

According to the Commission, the measure is justified by the “imminent risk of shortages of medical devices and the associated risk of a public health crisis”.

In addition to the aforementioned changes, the European Commission has announced that it will conduct a comprehensive assessment of the MDR by May 2027 to identify structural problems and analyze potential solutions. The European Commission also intends to fund actions to support implementation of the MDR, including notified body capacity and orphan medical devices. These actions will be funded under the EU4Health program beginning in early 2023.

Under the IVDR, IVD device manufacturers wishing to place their products on the European market, are required  to:

• obtain a CE mark to prove they are compliant with the new rules
• define the class of every device
• implement a quality system
• designate a notified body to audit all relevant documentation.

This latter aspect implies important imperatives in terms of the language of the documentation, including the labeling and the instructions on how to use the devices. Are you up to speed and able to manage this before the May deadline?

Download our White Paper and drop us a line to plan for a successful transition to IVDR and deliver compliant multilingual content.