Get The Industry News Roundup for September
In this month’s roundup of industry news roundup, we will be looking at how the USA and Canada are working to align their submission gateways to assist companies making regulatory applications. We will also look at a new EMA drug...
MHRA Moving Towards Paperless Communications
Following discussions with industry bodies, the MHRA is now replacing all paper-based communications with emails. The emails will replace paper-based communications about Common European Submissions Portal (CESP) submissions. Companies working with the MHRA will now receive emails to a single address...
Industry News Roundup: August
We are looking at five of the biggest stories in the pharmaceutical, medical devices and clinical trials sectors in the past month. Each month we will seek to highlight 5 key stories in trade publications and newsletters. This month we...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesClinical & MedicalFeatured NewsGemma RobinsonIndustry News
A Tightening of Regulations for Phase I Clinical Studies?
The Food and Drug Administration (FDA) has announced that they have launched a safety probe into fatty acid amide hydrolase (FAAH) inhibitors under investigation in the US. The investigation comes in the aftermath of a Phase I clinical trial in France, in which...
Acorn Regulatory to Exhibit at Med in Ireland – Dublin, October 29th 2015
Med in Ireland – October 29th 2015, Dublin Convention Centre, Ireland Acorn Regulatory is delighted to attend the Med in Ireland conference and exhibition on October 29th 2015. This biennial event is Enterprise Ireland’s largest medical technologies event, bringing together...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesIndustry NewsIVD DevicesMDD DevicesMedical Devices
Medical Device Post-Market Obligations – a European Perspective: Part 1 – Post-Market Surveillance
Under the European IVD and medical device directives, once a Manufacturer has CE marked their device and placed it on the market they still have to meet certain obligations. Implementation of a system for post-market surveillance is a requirement for...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesComplianceFeatured NewsHow-To & ExplainersIndustry NewsIVD DevicesMarketing Authorisation HoldersMDD DevicesMedical DevicesRegulatory Affairs
Do You Want To Find Out About CE Marking An App? Find Out More Here
There has been a veritable explosion in the number of mobile apps which act as aids to patients and clinicians – everything from medication reminders to apps which calculate drug dosage. In this brief overview we look at CE Marking an App....
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesIndustry NewsIVD DevicesMarketing Authorisation HoldersMDD DevicesMedical Devices
New European Medical Device and IVD Regulation – Where is it?
The long anticipated wait for agreement and adoption of the new European Medical Device and IVD Regulations will go on a little longer. Current predictions are that the new legislation will be adopted no sooner than Q4 2015, possibly extending...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesIndustry NewsIVD DevicesMarketing Authorisation HoldersMDD DevicesMedical DevicesRegulatory Affairs
Borderline Medical Devices Covered in EU Manual Update
With the rapid development of new software tools and mobile apps in healthcare, questions arising over classification will become increasingly common. Indeed, many questions have been raised about borderline medical devices. In such cases, the intended purpose of the app...
By using this website, you agree to our
cookie policy.
Close