A new In-vitro Diagnostic Regulation is currently in progress as part of the revision of European Medical Device legislation. The new Regulation will involve extensive changes for manufacturers. However, the legislative procedure is proving a lengthy one. After the 2014 European elections, voting on the new Regulation has been slow to resume.
EU Parliament introduces stricter requirements
The European Commission began work on drawing up a new Regulation for Medical Devices and in-vitro diagnostics in 2010, and published its proposals in September 2012. The first reading of the new law before the European Parliament was concluded on April 2, 2014, shortly before the European elections in May 2014. The old parliament had called for significantly stricter requirements compared to the Commission’s proposal, including:
Establishment of special – with the involvement of the European Medicines Agency (EMA) – Notified Bodies for future class D products
Generally stricter requirements for qualification and surveillance of Notified Bodies
Additional establishment of an Assessment Committee for Medical Devices (ACMD)
Replacement of the scrutiny procedure with case-by-case assessment by the ACMD
Further-reaching duties of disclosure, particularly for manufacturers and Notified Bodies
A shorter transition period, from five to three years
More detailed regulations
Position of the EU Council still open
Before the second reading, the member states, represented by the appropriate ministries, must agree on their requirements concerning the content of the new IVD Regulation. However, the EU Council has by now not succeeded to establish a common view. According to a press statement on the EU Council meeting of June 19/20, 2014, the Council aims to reach a common position by this autumn. To accelerate the process, a trialogue between the EU Commission, the EU Parliament and the EU Council is planned, with the goal of achieving consensus at the second reading if possible.
Directive will not be passed before early 2016
Given the complexity of the issue, the deadlines and the time-consuming nature of the documentation, the new IVD Regulation will probably not be finally adopted for at least another year. At present some major changes still have to be defined in detail, and the date of entry into force and the transitional period are still open. However, it is certain that the new IVD Regulation will significantly increase the efforts involved in regulatory compliance and respective surveillance for all stakeholders – from manufacturers to Notified Bodies and official bodies.