2016年 5月 3日
As we wrote earlier, European Regulations for Medical Devices and IVDs are still in their “First Reading” stage. In order to come to the formal First Reading document, the European Parliament, the Council and the European Commission are now negotiating under the Dutch EU-presidency.
Trilogues
The Dutch appear to be doing a very good job keeping the negotiations productive and informing stakeholders about the progress. We were invited to a second meeting that was organized for stakeholders on 28 April 2016 to provide information about the current state of affairs.
The main message brought to the industry was that it is highly likely that the First Reading version will be agreed upon in mid-June.
There appear to be two items that are still under fierce debate: genetic counseling and reprocessing of single-use devices. Neither of these issues was discussed in any detail, although it appears a compromise between Parliament and Council about reprocessing met strong resistance by the Commission.
Other open items are still moving towards workable compromises:
State of play
From the above it is clear the negotiations are effective. You can also see that some pragmatism is being applied when it comes to the conformity of devices with obviously proven safety. Some of the fears that well-established therapies will no longer be available because of devices that are no longer CE-marked will not come true. However, this will not be applicable to all devices, and it will not do away with some of the other challenges, like the accreditation of notified bodies.
The First Reading version of the Regulations will be made public as this is also a Parliament document. Of course Emergo will make this available as soon it is published, hopefully during the second half of June.
Preparation for the transition
The big questions the medical device industry is struggling with are how to prepare for the transition and when to start. Based on last September’s Council version of the proposals and the above, the broad picture is more or less clear:
Although this information is very general it can help individual organizations to get the transition process started. Companies should consider the following preliminary steps in preparation:
Start now
Start by downloading the Council’s September 2015 version of the proposals for medical device regulations and annexes as well as IVD regulations and annexes. It appears many items of this version will make it to the final version. By the time the First Reading version is published you may have a first version of your gap assessment. You may want to verify your initial device classification. By that time the details of the conformity assessment procedures will become clear. Of course Emergo will follow these developments closely and provide updates as we learn of them and can confirm their validity.
Ronald Boumans is Senior Global Regulatory Consultant at Emergo’s office in The Netherlands, and a former senior inspector at the Dutch Healthcare Inspectorate.