Earlier today the Dutch minister of Health and Labour, Mrs. Edith Schippers, thanks the members of the Dutch delegation that were behind the successful closure of the trilogue debates. She focused in her speech on the teamwork and great efforts displayed by the relative small group of staff, and supporting experts from various Dutch institutes.
The formal thanks were spoken in the middle of the stakeholder meeting, where the Dutch delegation provided text and context to the Dutch industry and other interested parties. A roller-coaster ride resulting ultimately in the agreement now reached, but just the first step as the further implementation will take yet another big junk of energy, as the department head Marcel van Raay introduced the event.
Hannah Koppenaal briefly summarized the history of the development of the current text, and highlighted the achievements reached during 7 presidencies prior to the Dutch presidency, that started on Jan 1st this year. Since 2008 there have been 99 council workgroups, 10 political trilogue meetings and 30 technical meetings, 20/5/23 of which were held during the Dutch presidency.
Rico Buitink elaborated on the highlights, disappointments, and great achievements during the last 6 months. Big topics such as endocrine disruptors, genetic counseling, the negative and positive lists for reprocessing of single use devices, and at the last minute the freedom of information / freedom of press discussions around the Swedish clause and article 1.8a.
Agreements have been reached in all debates, which were explained in detail by Daniëlle van Mullekom. In her talk she focused on the debates on scrutiny, CMR and endocrine disruptors, liability insurance, reprocessing, genetic counseling and freedom of press. One of the last additions is that of the class I – re-use clause, where notified bodies will need to do a limited review of re-use of surgical instruments, similar to their focused assessment of class I sterile and class I measuring devices. And another one the last minute inserted rule 10a, bringing various classifications into the software world.
As the council has confirmed the compromise at ministerial level on June 17, the next steps ahead are more administrative in nature. In 3-4 months’ time the translations will be finalized, allowing council (or Coreper if so chosen by the presidency) to finalize their first reading. When the co-current legal-linguistic review is finished as well, by the end of the year the Parliament can finalize the work in an early second reading.
Transition will be softer than anticipated, with the extended validity of the certificates under the current directives. That will allow a smoother time to get CE certificates in place, also in the years following the transition. On the other hand one should realize that manufacturers should be compliant with the MDR/IVDR at the end of the transition period, at the time of application. Even if they cannot show it yet with a new MDR certificate. Next to that there is the allowance to sell out stock for even a longer period.
Also well-established technologies have found some last minute exemptions from the need to do clinical trials and high level supervision.
The joint authorities will start preparing for roadmaps, for common specifications, and for working mechanisms of EUDAMED and of coordination teams for joint tasks. And in particular for their own stakeholders, the Dutch authority will be there to help support the industry to make it through the transition in a controlled effort.
As the text is deemed final, the work of the implementation can now truly begin!
Dr. Gert W. Bos, Executive Director & Partner at Qserve consultancy
More information about the writer: