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Europe: The Urgency to Grouping IVD Registrations Correctly Under EU IVDR
- ARQon
- Sep 20, 2021
- 3 min read
The European In Vitro Diagnostic Regulation (IVDR) will be enforced in May 2022. Once it takes into effect, a Notified Body will be required to CE-certify 80%-90% percent of all IVDs, a significant increase from the IVDD's requirements which is about 10%-20%. This massive increase has worried the industry, particularly among those who are unfamiliar with the new IVDR rules.
IVDR Classification of IVD Devices
The In Vitro Diagnostic Regulation (EU 2017/746) divides items into four classes based on their risk level: Class A, B, C, and D. Article 47 mentions the classification rules, which are detailed out in Annex VIII, as per below.
Class A IVD Classification – Refer Rule 5
Class B IVD Classification – Refer Rules 1-5 and then Rules 6-7
Class C IVD Classification – Refer Rules 2-4
Class D IVD Classification – Refer Rules 1-2
Annex VIII's classification rules are quite broad. Most IVD manufacturer who’s IVDs were previously designated as List A or B (greater risk) under the IVDD will now be classified as higher-risk Class C or D under the IVDR. Besides, many self-test IVDs will be reclassified as Class C. All of these require intervention from a Notified Body, yet they only account for around 20% of all IVDs. The real difference is happened to any IVD that is not in List A or B (referred as General List, hence self-certified). Under the IVDR, around 80-90% of these self-certified IVDs will be subject to a Notified Body assessment and audit.
Due to arising of many questions regarding this IVDR classification rules, Medical Device Coordination Group has published a guidance document, MDCG 2020-16 in November 2020.
The Significance of the Intended Purpose Statement
Section 1.1 of Annex VIII of the IVDR states that “Application of the classification rules shall be governed by the intended purpose of the devices.” This is significant because IVD companies are unique in that a single technology or platform can easily be incorporated into hundreds of distinct products, necessitating the requirement for separate CE Marking certificates for each intended use. It follows by Section 1.8 that states that “Where a manufacturer states multiple intended purposes for a device, and as a result the device falls into more than one class, it shall be classified in the higher class.” By looking at these 2 points, you can see that intended purposes statement is very crucial and companies must carefully consider what need to be included and how particular it needs to be.
Categorize Product Into Families
Rather than submitting a single IVD, an IVD system, IVD sets, or test kits to the NB, you can see if multiple in vitro medical devices can be combined as a family, group, or cluster in one product registration application with one technical documentation.
If multiple products can be grouped into families, your Notified Body will be able to assess them more quickly, resulting in lower costs and an easier road to CE Marking. Even though members of an in vitro diagnostic medical device family may have varied characteristics, they must all serve the same intended purpose and come from one legal manufacturer. However, if the products are manufactured by many manufacturing facilities, the company headquarters may be recognized as the legal manufacturer.
Challenges to Manufacturer
External
· Competent Authorities have taken a long time to designate European Notified Bodies to perform IVDR audits. Until now, only a few bodies have been approved (see NANDO IVDR database) and it is expected that demand will exceed supply considering the large number of IVDs that will need intervention by a Notified Body.
Internal
· Manufacturers may be unable to cope with the influx of new needs due to a lack of personnel or experience.
Unlike the transition of medical devices to the EU MDR, the huge majority of IVDs will be reviewed for the first time by a Notified Body. Hence, get advice from your chosen NB and start your internal planning. The NB can help to decide whether or not you can go. Devices that already have CE certification under List A, List B, or Self-Test may benefit from Article 110's transitory clause, which permits an IVDD CE-certified device to be on the market until May 2024. Thus, you will be able to prioritise products that must comply with the IVDR requirement by May 2022. This will aid in the organisation of technical documentation updates and the preparation of products for CE marking.
All manufacturers are advised keep in touch with your chosen notified body to understand more on the compliance to EU IVDR.
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