News on Medical devices and Medical Devices Regulation
Medical Devices: what changes with the AI Act?
With the entry into force of the AI Act, new rules are established for medical devices based on artificial intelligence (AI).
MDR extension: clarifications on Regulation (EU) 2023/607
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
MDR extension: the postponement of the transition period is official
Regulation (EU) 2023/607 extends the validity of the certificate of medical devices until 2027 or 2028 based on the risk class.
MDR: applicability is official, is everything ready?
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.
MDR: the main news
The MDR, which replaces the old Directive, implements several new features. Here they are.
MDR and the Delegation Law: the areas to be redefined
rom Post Marketing Surveillance to the GDPR, here are the government decrees for the implementation of the MDR.
MDR and manufacturer’s information: all the news
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.
MDR Post market surveillance: manufacturers requirements and obligations
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.
Medical Devices Regulation: what UDI is
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.
MDR and significant changes: here are the modifications to avoid to take advantage of the transitional period
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.
Medical devices and declaration of conformity: the 10 requirements for its validity
One of the novelties of the new Regulation 2017/745 [...]
Medical devices regulation: the requirements to take advantage of the transitional period
In April 2020, the full application of the new [...]
MDR (Medical Device Regulation): the postponement is official
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.
Medical devices: marketing authorization in USA and China
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?
Medical devices: 26th May 2020, a likely date?
A few months from 26th May 2020, the date of [...]
Medical devices and safety: what will change with the new rules
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.