News in Brief

The UK has published first details about the new registration requirements that will apply in the event of a hard Brexit. This will apply to all manufacturers of medical and IVD devices who wish to place their products on the … Continue reading →

It seems that three out of the four UK notified bodies will not be ready early enough for a no-deal Brexit, almost certainly compelling device manufacturers who use their services to hold back products from the market while the companies … Continue reading →

There is encouraging information for the EU medical technology sector regarding getting ready for timely compliance with the database elements of the new EU medical device regulations.

The UK’s MHRA is assuring a consultation process to obtain feedback on how medtech would be affected by a no-deal Brexit. At the moment there are insufficient knowledgeable, expert personnel and an abundance of unanswered questions.

The German State Economic Ministers Congress, among others, is asking the country’s federal government, as part of negotiations with the European Commission, to lengthen the particularly short transition periods for EU regulations MDR and IVDR.

The UK, as well as EU27 are anxious to know what they can do to start getting ready for Brexit. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have released two documents trying to give some kind of understanding … Continue reading →

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Because the EU MDR introduces extra information which has to be incorporated into labels, businesses are being compelled to design new label templates to enable more data to be printed.

Conformity with Eudamed database under the European Medical Devices Regulation (MDR) and in-vitro Diagnostics Regulation (IVDR) may be some time away but organisation for the new requirements will take continuous work.

Under the MDR certain products without an intended medical purpose are regulated as well. Manufacturers should carefully check with annex XVI.