News - 14 July 201707/14/2017
In Vitro Diagnostic Device Regulation (IVDR)
The new In Vitro Diagnostic Device Regulation (EU) 2017/746 was published in the Official Journal of the European Union on 5 May 2017.
The IVD Regulation is significantly different to the IVD Directive that it supersedes, including changed classification rules and requirements for conformity assessment. It is intended to strengthen the current approval system for in vitro diagnostics, making substantial changes to the existing IVD Directive (98/79/EC) legislation, first introduced in 1998.
The revision is being introduced as a Regulation instead of a Directive. A Regulation has been determined to be the most appropriate legal instrument, because it imposes clear and detailed rules which do not give room for divergent transposition by member states. Moreover, a Regulation ensures that legal requirements are implemented at the same time throughout the Union.
The IVDR introduces a new risk-rule classification system based on the Global Harmonization Task Force rules for classification which, for the first time, takes patient impact into consideration. This change to the classification system will have an impact on all manufacturers of IVDs. The majority of IVDs are currently self-declare devices but under the new regulation about 80% of IVDs require some form of conformity assessment by a Notified Body.
In the new classification system, IVD devices will be divided into four Classes of risk: A (lowest risk), B, C and D (highest risk). By using the seven classification rules, devices will be divided into one of the four classes that will dictate notified body involvement. The conformity assessment procedure for lowest-risk Class A devices will be the sole responsibility of the manufacturer. Class B, C, and D devices are characterised by increasing risk levels and will all require notified body involvement.
Timetable for introduction and transition
The new regulation was published on 5 May 2017 and entered into force on 25 May 2017. The IVDR will become applicable five years after its entry into force.
Implications for laboratory medicine
The IVDR has major implications for the manufacturers of the IVD diagnostics used in laboratory medicine and for the laboratory medicine specialists that use them. Those implications are being considered and will be presented at the ‘Accurate results for patient care workshop’ that is being organised in December 2017 by JCTLM (details available from http://www.bipm.org/en/committees/jc/jctlm/workshop-2017.html ) JCTLM will have a particular interest in what the IVDR has to say about the traceability of IVD products. Further news items will appear in due course.