Video clip: Dr Peter Havel: MDR and IVDR kick-off – The new regulations in Europe
MDR – in a nutshell. Our FAQ series
The new MDR came into effect in May. All medical devices falling under the scope of the MDR will need to be recertified by the end of the three-year transition period. In the new series, “MDR – in a nutshell,” our MDR insiders explain what this means for the industry in practice and which regulations need to be interpreted in more detail.
Since the new EU Regulation on IVDR came into effect in May, the clock is ticking – for the first time, this group includes many institutions and companies to which the previous EU directive had not applied. All devices falling under the scope of the IVDR will require new or recertification within the next five years. In connection with the new IVDR, there are three questions which you need to answer now.
TÜV SÜD has carried out more than 1,000 unannounced audits at medical device manufacturers worldwide since March 2014. The surprise visits to factories follow from EU Commission Recommendation 2013/473/EU of September 24, 2013, and have since become a mandatory element in the audit program of the Notified Bodies. The TÜV SÜD auditors have collected the questions frequently asked by manufacturers in unannounced audits and compiled them in a clear and concise FAQ document.
Since 2011, TÜV SÜD has offered support for medical device manufacturers in the preparation of the technical documentation for reprocessing according to EN ISO 17664. Official documents are now confirming the international hygiene drive in the healthcare sector, where the focus of interest is increasingly turning to instructions for use (IFU) for the reprocessing of medical devices.
The Russian government has extended the deadline for the replacement of old registration certificates of medical devices by another four years. Certificates that previously ran for an indefinite term can now be replaced up to January 21, 2021.
The successful medical technology conference Medicine Innovative – MedTech Summit has been held biennially for almost ten years. Its high popularity inspired the idea and concept of a new trade exhibition: MT-CONNECT! We provide insights: Dr. Bassil Akra, our Vice President Global Focus Teams Cardiovascular, Orthopedic and Clinical, and Dr. Klaus Schichl from Biotronik GmbH & Co. KG will explain the challenges that the new MDR will bring you.
The regulatory world is facing a big change since more than 2 years. In Europe a MEDDEV Guidance Document was published in June 2016 enforcing the requirements on clinical data and clarifying the minimum requirements on the quality of these data for CE Marking Process.