2nd Acorn Regulatory MDR Whitepaper: Be Prepared for May 2020

Our second Acorn Regulatory MDR whitepaper looks at the issues of unique device identifiers, the role of Eudamed under MDR and post market surveillance.

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

PV Update

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

Download it here.

What Happens Next?

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.

Deadline 2020 – Are You Ready?

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.

Regulatory Intelligence 5 

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

and

  • What You Need To Know About MRP Grouped Variations

Download it here.

About the Authors:

Gemma Robinson, PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects. You can read more articles by Gemma by clicking the link below.
Other articles by Gemma Robinson PhD

Orla Keane
Medical Devices Manager
An engineer by background, she has 15 years experience in medical devices. Prior to joining Acorn Regulatory, she spent over 12 years at the HPRA in various roles within the medical devices team. She was responsible for a team within post market surveillance and vigilance across various general and active implantable medical device product families. Orla also served as co-Chair of the Compliance and Enforcement working group in Brussels for many years. She has previous industry experience at an orthopaedic implant manufacturer. Orla currently assists Acorn Regulatory clients in a variety of areas including regulatory strategy, EU authorised representative support and preparation for MDR, particularly on the topic of post market surveillance. You can read medical device and related articles written by Orla Keane by clicking the link below.
Other articles by Orla Keane

Bronwyn Kelly
Senior Regulatory Affairs Advisor - Medical Devices
Bronwyn Kelly is a Senior Regulatory Affairs Advisor in our growing medical devices team. She has a wealth of experience in both device and pharmaceutical regulatory affairs and she has worked with some of the world's biggest companies in both sectors, In her current role she works with device clients on issues such as EU Authorised Representative and PRRC (Person Responsible for Regulatory Compliance) related issues. You can read medical device and related articles written by Bronwyn Kelly by clicking the link below.
Other articles by Bronwyn Kelly