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
mdi Europa will attend Medical 2018. Do you want to schedule a meeting? Please get in touch.
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.
Manufacturers of Own-Brand Label (OBL) devices will have to make sure under the MDR that they have full access to the products technical documentation.
Guidance on the application of the EU Medical Device Regulation on health software is in progress, but it will lack a more large-scale revision to the approaching rules that many in the sector are asking for.
Rugby helmets, autopsy saws, UV flow germicidal and water filters were some of the products not regarded as having a medical intended purpose and therefore do not fall under the definition of a medical device, as stated in the version … Continue reading
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