2nd Acorn Regulatory MDR Whitepaper: Be Prepared for May 2021
Our second Acorn Regulatory MDR whitepaper looks at the issues of unique device identifiers, the role of Eudamed under MDR and post market surveillance.
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.The Acorn Regulatory medical devices team, headed by Orla Keane, has looked at the major issues that will impact on device manufacturers and suppliers.
In our first whitepaper, released earlier this year, they looked at the role of the Person Responsible for Regulatory Compliance and the enhanced role of the EU Authorised Representative.
Now, in the second MDR whitepaper they look at further issues that will impact upon companies preparing for the new MDR. Again, they have considered the ‘hot topics’ from the clients that they have been working with and questions submitted to them through the Acorn Regulatory website.
In this edition they look at:
- The role of Eudamed under MDR
- Post Market Surveillance
- What will happen to UDI’s under MDR?
Download your copy of the second Acorn Regulatory MDR whitepaper by completing the form below.
Recent Publications from Acorn Regulatory
Acorn Regulatory’s pharmacovigilance and medical teams work with some of the largest and most dynamic companies in the world. They have looked at the major issues impacting their clients at the moment and have created ‘PV Update’ which is our latest PV e-book.
‘PV Update’ considers issues such as:
- An overview of post authorisation safety studies
- The role of the QPPV after Brexit
- What will a UK PSMF look like?
- The increasing obligations of scientific literature
Our ‘no deal’ whitepaper takes a look at the likelihood of a ‘no deal’ Brexit and how that will impact on the life science sector.
Our pharmacovigilance team look at the measures that companies need to put in place now if they are to prepare for the UK leaving the EU without a deal. The role of the QPPV has been much discussed in recent years, since the outcome of the referendum became known, and companies need to be aware of the implications that Brexit will have on that role.
The medical devices team look at the role of the EU Authorised Representative and the implications for Notified Bodies. The devices sector is in a particular ‘state of flux’ at present with the introduction of new legislation and Brexit adds to the issues that device manufacturers need to be mindful of at this time. Download it here.
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 still much work to do. Also, companies are still actively seeking further information about the regulations and how they will be applied. Download it here.
In this edition we look at the following topics:
- Pharmaceutical Development for Historic Dossiers
- Good Pharmacovigilance Practice (GvP) & Social Media
- The EU MDR & The Authorised Representative
- Advice for Companies Attending Scientific Advice Meetings
- What You Need To Know About MRP Grouped Variations
Download it here.