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The four biggest IVDR changes that the industry NEEDS to know

EU MDD, EU MDR, Medical Device Regulation, IVDR, In-Vitro Device Regulation, CE marking, Notified bodies, Clinical investigation, approval, definitions, medical devices

The latest drafts of the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR) were consolidated as of June 2016 and now we are awaiting the officially published regulation which is due late this year or early next year.

Anecto wants to highlight four big changes in IVD.

1. The definition of in vitro diagnostic devices has been expanded to include ‘nutrigenetic tests and lifestyle tests’. These are currently not included in the IVD Directive.

2. IVDs are to be divided into ‘risk classes’ as was defined by the Global Harmonisation Task Force (GHFT). This is a move away from the list based system currently used in the IVD Directive. The risk classes into which the IVDs will now be divided are rated A (low-risk) to D (high-risk). There will be seven classification rules applicable to these classes.

Rule 1: (Blood Screening, High-risk disease),

Rule 2: (Blood or tissue compatibility, High-risk blood groups),

Rule 3: (Infectious disease, Cancer testing, Companion diagnostics, Genetic testing, Congenital screening),

Rule 4: (Self-testing, High risk near patient tests),

Rule 5: (Specific IVD reagents, Instruments, Specimen receptacles),

Rule 6: (None of the other rules)

Rule 7: (Controls no assigned values).

Only class A devices will not require conformity assessment under the new regulations meaning there will be much more file reviews and audits to be performed on devices pre- and post-market. It will be difficult and very busy times ahead for manufacturers and notified bodies.

3. The busy times for notified bodies and manufactures doesn’t end there. Under the new classification rules, if an IVD doesn’t fit into any of the new rules it will be placed under class B and must be certified by a notified body. This is a major issue for industry which is still under discussion because if it is implemented in its current form, 80% of all IVDs will have to be certified as opposed to 20% under the current EU IVD Directive.

4. Much more clinical evidence will need to be produced by manufactures when applying for CE marking in line with the IVDR as clinical performance studies will now be required with each new application. The intention is in the long term to make manufacturers “fully responsible for the clinical utility of their devices”.

“In short, the clinical performance evaluation will include not only the classic clinical performance and analytical performance, but also scientific validity. With this change, the first steps towards manufacturers becoming fully responsible for the clinical utility of their devices are initiated,” according to a recent BSI report.

This short piece was inspired by the BSI’s ‘How to prepare for and implement the upcoming IVDR – Dos and don’ts’.