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How to use ISO 13485 to comply with In Vitro Diagnostic medical devices (IVD) requirements in UK

In vitro literally refers to a test or examination outside a living organism. This happens in a laboratory or a vessel or any other controlled testing location. In vitro diagnostic medical devices (IVD’s) comprise of chemical reagents, appliances, and systems anticipated for analysis and diagnosing a disease or any other medical condition. These IVD devices help to determine the health condition of the patient , to medicate, mitigate, cure, or avoid a disease incident in the first place.

Access to the supplier market of in vitro diagnostic medical devices (IVDs), device application, and market performance is regulated through European Directive 98/79/EC (IVDD). The IVDD is applied in the regulation of the member states of the European Union and, as a result, is enforced in UK. The new regulation was issued on 5 May 2017 in the Official Journal of the European Union as In Vitro Diagnostic Device Regulation (IVDR) 2017/746. The new regulation is published to cater to the needs of continuous scientific and technological advancement.

Considerations of the New In Vitro Diagnostic Device Regulation

The IVDR presents a new device classification system which is homogenous with that of Global Harmonization Task Force (GHTF) guidelines for classification, and is now risk-based, a modification to which will influence all suppliers of IVDs. Although not directly referenced, ISO 13485 can help. Some of the important outputs of the new regulation are:

1) Rational for Classification and conformity assessment: In the new system of classification, IVDs will be classified into four Classes or categories based on the level of risk. The classes are:

  • Class A (minimal or negligible risk)
  • Class B (normal risk)
  • Class C (significant risk)
  • Class D (extremely high risk)

The involvement of notified bodies for devices and company audits will be based on the class of device.

The conformity process for negligible risk (Class A devices) will not require involvement of notified bodies (Organizations selected by MHRA for assessment), and implementation of ISO 13485 will help to fulfill the regulation’s requirements. Devices in Class B, C, and D are described by growing risk levels respectively and all these classes will require a notified body to assess product’s conformity.

2) Unique Device Identification: Suppliers must make their devices traceable and identifiable with a Unique Device Identification (UDI) system. ISO 13485:2016 also addresses the same concern, in Clause 7.5.8 which requires a company to document a system for unique device identification. Thus, companies meeting the requirements of ISO 13485:2016 will already have this part of the regulation addressed.

3) Public Display of Summary for Device Safety: Companies providing Class C and Class D (high risk) devices will have to create a summary of device safety considerations, and application details such as clinical data. This summary must be made available to the public. ISO 13485 also requires organizations to conduct clinical trials under design validation protocols, whereas ISO 13485 along with ISO 14971 helps organizations to perform risk management. Therefore, conforming with these standards will help organizations effectively create such summaries.

4) Performance evaluation report: Suppliers will also have to establish conformity with the overall safety and performance criteria of the IVDs. They must submit a performance evaluation report based on the level of risk and associated Class. Again, the ISO 13485 designed systems can help in preparing such reports through risk registers, compliance handling and reporting of adverse events.

5) Observance and market surveillance: The new regulation will lead all member states to have an electronic portal, where suppliers can submit adverse incidents reports, safety corrective actions, flyer or field safety notices (FSN) and summary reports at planned intervals. MHRA already offers Electronic Adverse event reporting in UK. ISO 13485:2016 helps in almost all these requirements. It encompasses reporting of adverse events to a regulatory body, taking corrective actions, issuing advisory notices etc. The only thing suppliers have to do is to include these systems in the input stream of a regulatory body.

6) Notified Bodies: The status of notified bodies in respect to manufacturers/suppliers will be considerably reinforced. Notified bodies will have a privilege and obligation to conduct unscheduled factory inspections and to carryout laboratory tests or physical examinations on IVDs. The regulation also needs alternation of the notified body’s IVD inspectors at suitable intervals. This creates a balance in the understanding and knowledge needed to conduct comprehensive assessments. Implementing ISO 13485 makes a manufacturer’s life easier in case of an inspection i.e. it gives them ability to address many of the inspection’s concerns.

7) Schedule for transition to new regulation: The new regulation was issued on 5th May 2017 and brought into actual enforcement on 25th May 2017. The IVDR will be enforced completely after five years from the actual enforcement date. It means companies have five years to transform to new regulatory requirements after the enforcement date.

ln Vitro Diagnostic Device Regulation (IVDR) increases Device Safety

In the UK, MHRA is already guiding suppliers and manufacturers on new regulation. For example, the MHRA issued a guide for healthcare professionals which encompasses the application, administration, performance and safety of IVDs, together with point-of-care testing and blood glucose meters. The ln Vitro Diagnostic Device Regulation (IVDR) increases device safety by expanding the scope of the regulation, emphasis on clinical studies, and emphasis on device identification and traceability. It also places emphasis on tracking device performance in the market, unannounced factory inspections and increased involvement of notified bodies.

ISO 13485:2016 helps in meeting all new requirements only if it is implemented correctly. The organization should be always prepared by maintaining a state of audit readiness to pass an unannounced factory inspection.

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