The challenges that both manufacturers and notified bodies must meet can be summarized as follows:
- The impact of a completely new risk-based classification system for IVD devices will increase dramatically the number of IVD devices subject to notified body scrutiny. This will imply substantially greater resource needs for both the manufacturers and the notified bodies as well as an increased cost burden for the manufacturers
- The increased emphasis on quality systems, performance evaluation and post-market surveillance will affect IVD devices in all classes, although the Regulation includes an element of proportionality that is likely to be understood as being a function of the risk class. It is also likely that the practical application of the principle of proportionality will raise many issues of interpretation
- The potential for adoption of implementing acts by the Commission that could bring about further changes in the classification system
Immediate actions to be taken
You should carry out the following actions as soon as possible with respect to each of your IVD devices:
- Consider mapping out the basis for your claims (see Article 7) made because each product is likely to be subject to greater scrutiny than before. This would involve reviewing and critically assessing:
– the intended purpose of your products
– the performances for achieving the intended purpose
– available scientific and clinical evidence for supporting the claimed
– if you find any gaps in the evidence, take action to fill them
- Identify the applicable risk class of each of your products
- Identify the new compliance requirements resulting from the new classification system
- Carry out a gap analysis between your current compliance and the new requirements
- Develop an action plan to deal with the new compliance requirements
At the latest when your notified body is designated under the IVDR:
- Ensure that you have a common understanding between you and your notified body on any issues of interpretation regarding classification and the relevant compliance requirements. Please note that your notified body may require you to have a contract with them before they will comment on your compliance solutions or assess them
- Come to an agreement with your notified body on an implementation timeline
You should understand that there may be fewer notified bodies under the IVDR than there are currently under the directives. There are presently 21 notified bodies able to certify IVD devices (58 for medical devices). There could be as few as seven notified bodies designated under the IVDR. Because of the possibility that timely access to the assessment and certification by notified bodies will become a scarcer resource, it is important to prepare now for compliance. It is also important to establish early relations with the notified body with which you intend to form a relationship and resolve any potential disagreements about classification as early as possible. This process may involve approaching the relevant national competent authority for an opinion.
Class A IVD devices that do not require certification by a notified body need to achieve compliance and be self-certified by May 2022.
This is an excerpt from the BSI medical devices white paper: Explaining IVD classification issues. To browse our collection of medical device white papers, please visit the Insight page on the Compliance Navigator website.