News in Brief

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 →

There has been some bewilderment and opposing views about notified bodies performing mock audits on companies’ documentation to demonstrate conformity with the impending EU Medical Device and IVD Regulations.

Belgium has brought in new registration requirements for medical device and IVD operators in advance of the full application of the EU’s medtech regulations and new Eudamed medical device database.

The General Data Protection Regulation (GDPR) went into operation all through the EU, including the UK, on May 25. Medtech, along with every other industry has been preparing itself for this. But the impact of GDPR is extensive and there … Continue reading →