Preparing for XYZ Regulation 

Regulation XYZ will come into law on 1 January 2028 and will replace the current legislation (ABC). It sets out new requirements for manufacturers making medical devices for the EU market. 

Aim of the Regulation 

The new Regulation introduces measures to make medical devices safer and more effective for the people who use them. It replaces outdated legislation and responds to the technological and scientific progress in the medical devices sector. 

What are the key changes from previous legislation?

There are changes to three key areas, as outlined below. 

New types of medical devices included

The new legislation applies to a wide range of medical devices, and includes new types including:

  • X
  • Y
  • Z

New types of manufacturers included 

The new legislation extends to a broader list of  manufacturers . The following are now included:

  • X
  • Y
  • Z

Mandatory registration processes

It is now mandatory to register with the HPRA for the following activities:

  • X
  • Y
  • Z

Who must comply?

All manufacturers making medical devices for the EU market are required to comply with the new requirements.  

What is the deadline for compliance?

There are two key deadlines.

  1. Register with the HPRA no later than 20 October 2027. 
  2. Comply with all requirements no later than 1 January 2028.

Are there any exemptions or transitional periods?

Transitional periods and exemptions apply in specific cases. Select the cases that apply to you.

X type of medical device

You must:

  • Register no later than 1 January 2028
  • Achieve full compliance no later than 1 January 2029
X type of manufacturer

You must:

  • Register no later than 1 January 2029
  • Achieve full compliance no later than 1 January 2030

Manufacturers based in the EU

No exemptions apply. You must register and comply according to the primary deadlines. 

  • Register with HPRA 20 October 2027
  • Full compliance required by 1 January 2028
Manufacturers based outside the EU

Follow the requirements for the country where you are placing the product on the market. 

Medical devices placed on the market before 2027

Contact the HPRA for an assessment and further directions. 

What actions must manufacturers take to prepare?

  • Register with the HPRA by 20 October 2027. 
  • Contact the HPRA if you are unsure whether you need to register or if you cannot complete registration.
  • Follow the requirements set by the European Commission in its New Regulations guidelines. 
  • Put the procedures in the HPRA's Guide to XYZ Regulation in place.

Guide to XYZ Regulation

PDF : 107 KB | 29/06/2026

How will the HPRA monitor compliance?

The HPRA will carry out the following actions to implement the Regulation in Ireland. 

  • Confirm registration for manufacturers who complete the process and provide all required information 
  • Contact manufacturers who have not completed registration, where possible 
  • Monitor compliance with safety reporting requirements and notify manufacturers if action is needed urgently

When will the next updates be available?

The HPRA and the European Commission will publish guidance in 2027. 

  • The HPRA will publish new guidance on [enter topic] in January 2027.
  • The HPRA will also update existing guidance on [enter topic] in April 2027.
  • The European Commission may publish guidance on [new topic] in 2027; however, no publication date has been confirmed yet.

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