Get The Acorn Regulatory Medical Device Regulations Whitepaper
The new medical device regulations (MDR) will come into force in May 2020. In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations. For many companies there is...
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Understanding MDR: 8 Important Changes
The advent of the new Medical Devices Regulation (MDR 2017/745) is a cause of much concern for manufacturers and others in the devices sector. The new regulations will bring about many changes compared to the current regulatory framework. We look...
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EU Authorized Representative – Find Out What You Need To Know As Brexit Nears
In recent months we have assisted a large number of companies in transferring their EU Authorized Representative from the UK and into another EU country. Companies with an EU Authorized Representative in the UK have been forced to appoint a...
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....
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesBrexitEU Authorised RepresentativeIVD DevicesMDD DevicesMedical Devices
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...
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.
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