Medical devices: when is the expected revision of the regulation?

The Ministry of Health is still working on the final version of the amendment to the regulation on the list of medical devices on prescription. In an interview with CwZ editors, Maciej Miłkowski admitted that he had hoped for the new regulations to come into force as early as 1 July. Will this happen?

Everything indicates that the legal act awaited by the patient environment and medical device manufacturers will have to wait a little longer. As admitted by Deputy Minister Maciej Miłkowski, responsible at the Ministry of Health for drug policy issues and reimbursement of medical devices, work on the final version of the document is still in progress.

- I had hoped that it would be published at the beginning of June and enter into force from 1 July, but I have to say that I still have not received the conclusions of the public consultation (which lasted until the end of April - editor's note)- explained the Deputy Minister. He added that the draft amendment to the regulation, published at the beginning of April, received a great many comments, and the department in charge of the document has still not finished analysing them.

Source: cowzdrowiu.pl

More information and video at the link:

http://cowzdrowiu.pl/aktualnosci/post/wyroby-medyczne-kiedy-oczekiwana-zamiana-rozporzadzenia


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