REDUCING THE RISKS OF MEDICAL DEVICES: INTERNATIONAL GUIDANCE JUST UPDATED
Virtually no medical procedure is without risk, but there are many ways to minimize it. One such way is through applying sound risk management processes to medical devices. The International Standard to do just that has now been updated. ISO 14971, Medical devices – Application of risk management to medical devices, specifies the terminology, principles and process […]
Which EU Notified Bodies Have Been “Designated” Under the MDR 2017/745 and IVDR (2017/746)?
Last update Feb 6, 2020 With the MDR deadline quickly approaching , many medical device manufacturers still don’t know for certain whether their Notified Body will be designated and when! A handful of large Notified Bodies (NB) have been approved, but for the others we can only guess when (or if) their designation will happen. […]
PASSPORT TO TRADE
Whether it’s going to far-flung lands or just the neighbouring country, we all need a passport to travel. But what about products? How do bananas from Costa Rica get through customs in France? Or watches from Switzerland get past border control in Australia? Their “papers” are often in the form of documents such as certificates that prove they have passed the various rules and requirements of […]
Iran, Eurasia start preferential trade agreement
Both sides are supposed to pave the way for establishing free trade one year after implementing the agreement. The agreement consists of 862 products, 360 of which have been given by Iran to Eurasia and 502 others by Eurasia to Iran. Earlier, Iranian Energy Minister Reza Ardakanian said that Iran’s accession to Eurasian Economic Union […]
Medical device safety: IMQ has been appointed as the notified body for the new European Regulation
The notification, that was published on the 20th of August in the European NANDO system, allows IMQ to support right now medical device manufacturers in getting certification under the new MDR Regulation. The MDR – which will become mandatory as of the 26thof May and will replace the old Directives (93/42/EEC and 90/385/EEC) – is […]