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 and distributors. Update: You will see that some of our comprehensive MDR content that we have created refers to the May 2020 date of application.  The date of MDR application has moved to May 26th, 2021.  Articles that were written prior to the delay referenced the earlier date.  However, articles that you might read that reference the earlier date should be read taking the new date of May 2021 into consideration.  Read more here.

‘Be Prepared’ will look at issues such as:

• Overview of UDI (Unique Device Identifier system)
• Post Market Surveillance
• An overview of Eudamed

MDR has been dogged by issues, particularly the delay in appointing Notified Bodies.  Italy’s IMQ became the fourth Notified Body to be appointed (along with DEKRA, TUV SUD and BSI) in recent weeks. The pace of appointing NB’s has alarmed some in the industry and has led to calls for the delay to the implementation of MDR in May 2020.  Despite the clamour to delay implementation, the date has not yet changed and MDR will come into force on May 26th 2020.  Companies need to be ready. Sign up to receive your advance copy of the 2nd MDR whitepaper by completing the form.  Also, below, you can find the details of our medical devices team should you need to contact them to discuss any MDR related issues that your company might have. [ninja_form id=56]

Do You Have MDR related Issues?

If so, contact us on 00353 52 61 76 706 or email: info@acornregulatory.com

Have You Downloaded These Publications from Acorn Regulatory?

Drug-Device Whitepaper

The new MDR has significantly updated the requirements for medical devices placed on the European market. It has introduced new requirements for manufacturers to comply with to achieve CE marking before placing their products on the European market. Some of the principal changes are in the areas of the role of economic operators, vigilance and post-market surveillance, increased requirements for clinical evidence, and expansion of the scope of products covered under the regulation when compared with the previous directives. This whitepaper provides an overview of the legislative changes, with a focus on the requirements for products that are typically known as drug-device combination products.

The drug-device whitepaper looks at issues such as:

• the regulatory framework for devices
• what is a drug-device product and how are they defined as such?
• how are they regulated
• how does MDR change the requirements for drug-device products?
• combination products regulated as medical devices

The brief whitepaper also provides a handy drug-device checklist. Download it here.

Download ‘Regulatory Intelligence 8’

Edition 8 of the Acorn Regulatory whitepaper series ‘Regulatory Intelligence’ is out now and can be downloaded from our site.  This bumper edition looks at a wide range of sectors including pharmacovigilance, CMC & pharmaceutical, and medical device. Download it here.

Download ‘Regulatory Intelligence 7’ from Acorn Regulatory

‘Regulatory Intelligence 7’ is now available to download.  It is the latest edition in our popular series ‘Regulatory Intelligence’. This edition covers the following issues:

• Can You Use a U.S. Dossier to Apply for a European Marketing Authorisation?
• Clinical Investigations Under MDR
• The U.K. PSMF -What Will It Look Like?

You can download your copy here.

Download the 3rd Acorn Regulatory MDR Whitepaper

The 3rd Acorn Regulatory MDR whitepaper is available now.  This publication looks at Clinical Evaluation Reports, Conformity Assessment Routes, and Clinical Investigations under MDR. Download the whitepaper here.

Get The Latest eCTD Publishing Whitepaper Now

Our expert eCTD publishing team has written several whitepapers on issues relating to electronic publishing.  Now, they have compiled the most popular articles from recent months into a free whitepaper for you to download. Read the eCTD book here.