How Will The Northern Ireland Protocol Impact Medical Device Companies?

Our clients have been contacting us in recent weeks with questions relating to the Northern Ireland Protocol and medical devices.  They are eager to understand the intricacies of the Northern Ireland Protocol and how it will impact their companies.  We have gathered some of the most asked questions and provided answers for them in this guide.

We answer the following questions about the Northern Ireland Protocol:

  • Will the MDR & IVDR Apply in Northern Ireland?
  • Is the UK introducing an equivalent to the CE mark?
  • Is There a UK Equivalent of the EU Authorised Representative for Post Brexit UK?
  • What Should I Do If I Am A Manufacturer Based in Northern Ireland?
  • How Do I Register A Product in Northern Ireland?
  • If We Release A Medical Device Within The UK Prior To December 31st, 2020 And The Goods Remain In The UK, Can We Still Ship To The EU After January 1st, 2021 Without The EU AR Info On The Artwork?

Download the Guide Now

Further MDR reading from Acorn Regulatory

A Guide to Drug-Device Combination Products

We have produced a drug-device guide that looks at the issue.  It also considers the issue in relation to the changes for drug-device combination products in relation to the Medical Device Regulations.  You can download the guide here.

The 5 Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under MDR

As part of our series of articles looking at some of the changes on the way for medical device regulation under MDR, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC).

The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices. Read more here.

Get The 1st 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 still much work to do. Also, companies are still actively seeking further information about the regulations and how they will be applied. Read the first whitepaper here

2nd Acorn Regulatory MDR Whitepaper

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

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 from the MDD to MDR. During our interactions with these clients, many topics are being raised time and again. Read more here.