News in Brief

MHRA Publishes New Guidance about Registration Fees and Requirements for a Hard Brexit

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

Posted on 8. März 2019

Companies employing three UK notified bodies could have to defer certificates post-Brexit

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

Posted on 26. Februar 2019

Will the new Eudamed Medical Device Database be ready for March 26, 2020?

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.

Posted on 20. Februar 2019

Brexit: UK guarantees Medtech ‘no-deal consultation’

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.

Posted on 7. Dezember 2018

German ministers request longer EU MDR/IVDR transition

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.

Posted on 4. Dezember 2018

Two documents on Brexit implementation period published by UK MHRA

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

Posted on 1. Dezember 2018

Meet mdi Europa at Medical 2018

mdi Europa will attend Medical 2018. Do you want to schedule a meeting? Please get in touch.

Posted on 15. Oktober 2018

How does EU MDR impact the sticky labels?

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.

Posted on 15. Oktober 2018

Some important features regarding Europe’s Eudamed database

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.

Posted on 10. Oktober 2018

MDR – Products Without an Intended Medical Purpose

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

Posted on 9. Oktober 2018
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