Council of the EU publishes comments on draft IVD Regulation
After a period of seeming inactivity, the legislative process concerning the Regulation of the European Parliament and of the Council on in-vitro diagnostic medical devices is now gaining momentum.
A statement from the Council of the European Union has been eagerly awaited since the decision of the European Parliament of April 2, 2014, concerning required changes to the Commission’s proposal of September, 26, 2012. The Council published its preliminary statement on June, 19, 2015 after apparent laborious negotiations, bringing the conclusion of the first reading within reach.
Further readings are subject to tight procedural deadlines, so that the future IVD Regulation may be expected to be passed around mid-2016 assuming the parties reach consensus. The amendments proposed by the Council are numerous and to some extent very detailed.
The statement of the Council addresses all articles and annexes to the proposed Regulation with the exception of the justification in the preamble. The changes called for by the Council primarily focus on the UDI system, the European database, the Notified Bodies, clinical effectiveness/performance characteristics, after-sales product surveillance, vigilance and interaction of competent authorities.
Further major changes are
Materials for ring trials are to be exempted from the provisions of the Regulation.
The definition of companion diagnostic devices is to be expanded.
The rules for reagents produced in health-institution laboratories are to be formulated more precisely.
Manufacturers must undertake to implement a full quality management system.
The EU Representative is to take legal responsibility for faulty products.
A “qualified person” must also be available with the EU Representative.
A scrutiny procedure is only to be initiated after certification of a Class D product in case considered necessary.
Class A devices for near-patient testing or with measurement functions are not to be subject to evaluation by Notified Bodies.
All devices for self-testing are to be classified as Class C.
In contrast to the Parliament, the Council has adopted the Commission’s proposal of a five-year transitional period and does not demand “Special Notified Bodies”. The points mentioned do not yet reflect the actual wording of the future Regulation, so that we shall observe further negotiations between the Council, Parliament and Commission with interest.