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The race is on for companies to be among the first to CE mark their devices under the new EU regulations. Much will depend on which notified bodies are designated first; and national competent authorities play a key role.
Precise timing of application, and the quality of application dossiers are two key factors that will influence how quickly a notified body is designated under the EU's new Medical Devices and IVD Regulations.
According to a just-published Information note on joint assessments under the new regulations on medical devices from the European Commission, the day and the time of day the Commission receives the preliminary assessment report from the designating authority will be the main factor in deciding the order of the joint assessments –performed by the European Commission and representatives of two member states – and their allocation to any next available on-site assessment date.
The Commission has already been working on a tentative schedule of prospective on-site assessment dates to check the availability of both national and Commission experts. The intention is that future on-site assessments will then take place on those pre-established dates.
Another factor that may influence when notified bodies will be assessed by the joint assessment teams will be the availability of the team experts, the designating authority or the applicant conformity assessment body.
As an example, the Commission points to a situation where an application comes from a notified body that is established in a given EU member state, but one of the only two national experts available on the next on-site assessment date is from the same member state. In that case, the assessment will need to be rescheduled when two national experts from other member states are available, the Commission explains.
The Commission also stresses that it is of "utmost importance" that both the notified body’s application dossier and the designating authority’s preliminary assessment report are complete and properly address all the relevant legal requirements.
If any of these documents do not meet the requirements, it could cause a delay or a postponement in scheduling the on-site joint assessment to allow the conformity assessment body sufficient time to provide all the necessary clarifications and information.
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