2018’s Most Read Medical Device Articles from Acorn Regulatory
The Acorn Regulatory medical devices team has grown again in 2018 and in the past 12 months we have worked with a wide array of companies from around the world. In that time also, we have written a number of very well received articles, whitepapers and more. Here are some of the most read medical devices articles from the Acorn Regulatory site from 2018.
Notified Bodies – The Implications for the Medical Devices Sector
The implications of Brexit will, possibly, be felt most in the area of Notified Bodies. The UK’s exit from the European Union means that UK based Notified Bodies will no longer be permitted to provide conformity assessment services and issue CE Certificates of Conformity to manufacturers. There is no doubt that the upheaval caused by this will have an impact on the sector. Anecdotal evidence already suggests that Notified Bodies within the remaining EU27 members states are experiencing increased demands on their services and they are unable to meet demand in as quick a time as customers would like. Read more here.
New EU Medical Device Regulations: The Impact for Economic Operators
Two new EU Regulations entered into force on 26th May 2017. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR) replace the current three Directives, which have been in place since the early 1990s. There is a transition period for the implementation of the various elements of the new regulations, with MDR becoming fully operational in May 2020 the IVDR in May 2022.
Now is the time for those impacted by the changes to the medical devices regulatory landscape to prepare for implementation of the new regulations. In this, the first of a number of articles relating to EUDR, we look at some of the changes for Economic Operators.
In the current Directives, the legal responsibility for medical devices placed on the market lies firmly with the legal manufacturer of the device. The role of Authorised Representative for manufacturers based outside of Europe was established in the Directives but under EUDR the increased responsibilities of this role are more clearly defined. The new regulations specify obligations and responsibilities for all economic operators involved in the manufacture and supply of medical devices. Read more here.
New EU Medical Device Regulations (EUDR) & The Authorised Representative
Two new EU Regulations entered into force on 26th May 2017. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR) replace the current three Directives, which have been in place since the early 1990s. There is a transition period for the implementation of the various elements of the new regulations, with MDR becoming fully operational in May 2020 the IVDR in May 2022.
Now is the time for those impacted by the changes to the medical devices regulatory landscape to prepare for implementation of the new regulations. In the current Directives, the legal responsibility for medical devices placed on the market lies firmly with the legal manufacturer of the device. The EUDR provides detail on the additional roles responsibilities of various Economic Operators in the medical device supply chain. This was examined in our recent article here. In this second article in our series, we look in more detail at the role of Authorised Representative required for manufacturers based outside of Europe. It was established in the Directives to act as a contact point within Europe who could act on behalf of the manufacturer. The scope of the role of Authorised Representative has been expanded under EUDR compared to previously, and details may be found in Articles 11 and 12 of Regulation (EU) 2017/745. Read more here.
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