News on Medical devices and Medical Devices Regulation
Technical analysis of the proposed MDR and IVDR amendment: what changes for vigilance, PMS, PSUR, cybersecurity, Eudamed and EMA.
The latest edition of SD Collection, the SafetyDrugs special with insights, updates and useful advice on pharmacovigilance is now available.
With the entry into force of the AI Act, new rules are established for medical devices based on artificial intelligence (AI).
Following the introduction of the MDR extension, many doubts arisen for manufacturers. The European Commission has therefore published a Q&A dossier of clarifications. Here are the main points
Regulation (EU) 2023/607 extends the validity of the certificate of medical devices until 2027 or 2028 based on the risk class.
From today, the MDR, the new European Regulation on Medical Devices, that came into force in May 2017, has full applicability. After a one-year postponement due to Covid, it wonders how the various actors involved in the fulfilment of the new duties required by EU Regulation 2017/745 are.
The MDR, which replaces the old Directive, implements several new features. Here they are.
rom Post Marketing Surveillance to the GDPR, here are the government decrees for the implementation of the MDR.
With the entry into force of the MDR there are several areas that have been revised as they are treated more roughly in the old Directive, among these there are also the information supplied with the device: in order to present the correct use of your device , each manufacturer is in fact required to affix on labels, packaging and instructions for use, all the information necessary for its use, such as the risks and benefits, operating methods, CE mark, etc. Let's see the updates.
The Medical Device Regulation 2017/745, among other innovations, defines the concept of post-market surveillance, so far only mentioned in the MDD. Here is what it is and what are the obligations for the manufacturers.
One of the most important news introduced by the MDR 2017/745 regards the medical devices Unique Device Identification. Here it is what UDI is.
Here is the list of all significant and non-significant changes and dos and don'ts to take advantage of the transition period of the MDR.
One of the novelties of the new Regulation 2017/745 [...]
In April 2020, the full application of the new [...]
The application data of the Medical Devices Regulation (MDR) EU 2017/745 has been officially postponed, such as instituted by the EU Parliament vote on 17th April 2020.
The American and the Chinese are the main Medical Devices market in the world. In these Countries the devices classification is different from the European one. How to proceed to obtain the marketing authorization?
A few months from 26th May 2020, the date of [...]
On 26th May 2020 the 2017/745 EU regulation on medical devices will entry into force. It was discussed at 59th AFI Symposium, the Italian event dedicated to pharmaceutical sector. Here is what emerged.