2nd MDR Whitepaper: Get An Advance Copy
We will be publishing our 2nd MDR whitepaper ‘Be Prepared’ in October. You can sign up to receive a copy before it is available on general release. The second whitepaper will look at 5 areas that will impact device manufacturers...
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No Deal Brexit Planning – What We Know So Far
The ongoing coverage of the UK’s moves towards leaving the European Union continues. This is a difficult time for companies in the life science sector in the UK and outside of the UK as they work to ensure that patients...
Device Vigilance System Additional Guidance: An Update from Our Devices Team
While much of the medical device industry is focused on MDR, the MDD is still in effect. Our medical devices team has been following the latest developments on MDD and MDR on behalf of our client companies. In this article she...
Impacted By The LRQA Decision? Here Is How We Can Help
The decisions by Lloyd’s Register Quality Assurance (the LRQA) and QS Zurich that they will both will cease to offer notified body services under the EU’s existing medical device and in vitro diagnostic directives and that they will not seek...
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‘Selected Writing from Acorn Regulatory’ Download It Here
‘Selected Writing from Acorn Regulatory’ highlights just some of the most read articles written by our expert staff in the past 12 months. This e-book is packed with regulatory and pharmacovigilance insights from the team at Acorn Regulatory. Download it...
The Medical Device Regulations – MDR – What You Need To Know
The introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we work with medical devices. Our medical device team has been working with many companies to support them for the changeover...
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...
Acorn Regulatory To Present At ‘Manufacturing Excellence 2019’
Experts from Acorn Regulatory will be presenting at the ‘Manufacturing Excellence 2019’ event at the Questum Centre, Clonmel, Co. Tipperary on May 29th next. This is the second time in recent years that Acorn Regulatory has presented at the event...
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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...
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