Guidance for the EU Authorised Representative and PRRC (MDR 2017/745)
EU Authorised Representative and PRRC of medical devices have now the guidance about the duties and the responsibilities based on MDR 2017/745. Read more about Article 11 and Article 15 of the MDR 2017/745.
MDR transition period is changed
Begin January, the EU Commission formalized the proposal to update Art. 120, Art. 122 and Art. 123 of the MDR 2017/745. This has been done with intention of giving Notified Bodies (NoBo’s) more time to certify manufacturers and so that (legacy device) manufacturers intending to transition to the MDR, will benefit from the extended transition...
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EUDAMED - European Database on Medical Devices
Are you a manufacturer, authorised representative or importer of a medical device? If so, you will soon (most likely in May 2022) need to register information about yourself, your company and the medical device in EUDAMED.
MDR & Implementing Regulation (EU) 2021/2226
Implementing Regulation (EU) 2021/2226 makes possible for manufacturers of medical devices to provide electronic instructions for use only. Read more about the conditions of EU 2021/2226.
Breaking news: European Commission published second batch of harmonised standards under MDR
On January 4, the European Commission recognised nine harmonised standards for medical devices that manufacturers can reference in order to satisfy conformity requirements under the Medical Devices Regulation (MDR 2017/745).
MDR 2017/745 Implementation: Are you prepared?
MDR 2017/745 is in force. Get all the updates and requirements introduced by the new Regulation.
CE marking for medical software & Apps
Software and apps that are essential to the proper functioning of a medical device must be CE marked.