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We know from our own experience that EU MDR, imposes significant compliance and reporting requirements on many businesses. To help you navigate these complex rules, PwC has devised a systematic approach to developing EU MDR compliance, based on five key steps most organisations are likely to need to follow. This approach enables organisations to properly understand the regime, identify how the rules might impact transactions and what processes there should be in place to identify, analyse and report relevant arrangements. The five steps comprise:

  • Risk and impact assessment
  • Governance
  • Education and training with Learning Lab
  • Assessment, recording and reporting using our DAC6 Smart Reporting tool and
  • Testing and compliance

And here’s how we can help you with each step:

Risk and impact assessment and governance

Talk to us about the client workshops we run covering:

  • Overview of the new rules and the types of transactions that could be in scope
  • Risk assessment to help identify and risk assess which hallmarks may apply to your business.
  • Impact on previous and proposed transactions, and
  • Ongoing governance: how to respond to / monitor compliance

Education and training - Learning Lab

Demonstrating an understanding of the legislation is fundamental to the correct application of DAC 6. PwC has developed a versatile mobile and desktop app, Learning Lab with a specific module on EU MDR. Find out more in the EU MDR Learning Lab download below and listen to Andy Olymbios (TRS partner) talk about the importance of robust training in the video below.A “good to know” is that the training can be tailored to your specific requirements and can be delivered either with PwC support or internally.

Assessment, recording and reporting - DAC6 Smart Reporting

DAC6 Smart Reporting is a brand new PwC developed online reporting tool that provides a central digital record of discloseable transactions, including hallmark assessments and automatically populated disclosure forms. Data visualisation provides central oversight of disclosures (by territory, hallmark, business unit etc). For more about DAC6 Smart Reporting see the related download below. 

To find out more about how our technology can help you meet your reporting obligations, please get in touch with one of our EU MDR specialists below to book a 30 minute discovery session.  

Testing and compliance

PwC can help you with the development of testing plans and key control analysis, as well as provide specialist support for internal audit or external review. It is critical that controls are kept up to date and fit for purpose.

What’s next?

Territory guidance will be published by HMRC on the UK requirements sometime this summer.

To summarise, listen to Andy Olymbios's short video below, on EU MDR and how PwC can help organisations comply with these complex regulations.

To find out more, any one of our EU MDR specialists listed below would be delighted to hear from you, or please talk to your usual PwC contact.

Andy Olymbios, Partner 

Matt Gibson Partner 

Rachael Palmer, Director 

Emmet Bulman Director 

Robert Gooding, Director 

Kate Cornelius, Senior Manager 

Richard Anderson, Senior Manager 

Adeela Thantrey, Manager




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