26 May 2022 has now come and gone, bringing with it a new era of IVD Regulation in the EU. Unfortunately, the outgoing Directive was unable to keep up with the advances within the IVD sector, with many relatively high-risk products falling under the General IVD category, such as those detecting cancer within a sample. Such products have been allowed to enter the market with very little scrutiny and were generally passed through the self-declaration route.
Nevertheless, many of these devices registered as General IVDs under the IVDD will require Notified Body intervention under the IVDR, and may therefore benefit from the extended stepped transition period as provided by Article 110(3). These are referred to as legacy devices.
On the other hand, devices registered as General IVDs under the IVDD which will not require Notified Body intervention under the IVDR will need to transition to the Regulation in order to place product on the market after 26 May 2022. Although the industry has been provided 5 years in order to prepare for this transition, it will still come as a shock to many when their IVDD-compliant products are not allowed market entry.
The EU IVDR is a very complex regulation and presents a steep learning curve for the industry in general (that includes manufacturers, Notified Bodies, Competent Authorities, and consultants alike!). What can be agreed upon is that there is now a set of clear requirements which will need to be met, including:
- Technical documentation compliant with Annexes II and III of the EU Regulation.
- Quality Management System taking into account the points in Article 10.
- Appointing a Person Responsible for Regulatory Compliance (PRRC), in accordance with Article 15.
- Registration of Actors and Devices on Eudamed.
- UDI requirements.
Whichever classification your IVD falls under within the Regulation, there will be a lot of work involved in getting your product’s documentation in line with the new requirements. For those manufacturers who are struggling with compliance to the IVDR, our in-house consultants can be of help. The IVDR is, to say the least, a complex text to digest. Requirements relating to your obligations as a manufacturer and technical documentation can be difficult to understand. With years of experience in reviewing and putting together technical documentation, Advena Ltd. has the resources available to guide you through the requirements of the IVDR and ensure that you understand and comply with all the relevant requirements.
Contact Advena Ltd. today at info@advena.mt for more information.
