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...
Brexit & Notified Bodies – What Are 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...
What You Need To Know About the EU MDR & 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...
EU MDR: What Will The Impact Be 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....
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10 Responsibilities of a EU Authorised Representative
The responsibilities and role of the EU Authorised Representative (or EUAR) is now in the spotlight as a result of the UK’s decision to leave the EU. Many companies have previously chosen EU Authorised Representatives from the UK and, as...
EU Parliament Adopts New Diagnostics and Medical Device Regulations
The European Parliament has endorsed the new InVitro Diagnostic Medical Devices (IVDR) and the new Regulation on Medical Devices (MDR) at a sitting today (April 5th, 2017). The long-awaited final vote is the last step in an almost 8-year...
EU Authorised Representatives Post Brexit: What Happens Next?
The UK’s impending departure from the EU will necessitate a change in designated EU Authorised Representatives for companies that are currently using a UK based authorised representative at present. This will cause considerable upheaval and disruption to companies using such...
Most Read Medical Device News Stories on AcornRegulatory.com in 2016
We’re looking at the 5 most read medical device news stories from AcornRegulatory.com for the past 12 months. What a year we have had globally.
CE Marking a Medical Device That Incorporates a Medicine
We are consistently asked about CE marking a medical device. Our team of medical device experts has written a brief overview of how a company can secure CE marking for a medical device that incorporates a medicine.
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Benefits of Outsourcing Regulatory Affairs
The developments in the market, mergers and the issues associated with pricing pressures applied by governments (such as the IPHA deal and the AMNOG deal in Germany) has caused companies to address internal issues and to seek to minimise the negative...
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