Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 94

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 94
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 class IIb implantable devices; |

| • | 2028 for other class IIb, class IIa and class Is, Im devices; and |

| • | 2028 for class I up classified devices. |

The transitional provisions allow time for devices CE marked under the Directives to transition and become CE marked under the MDR. 49 Table of Contents In the UK, medical devices currently continue to be regulated by laws equivalent to the EU directives which preceded the MDR. The UK Government is planning to introduce new UK Medical Device Regulations, although these are unlikely to become law prior to 2025. In the meantime, manufacturers whose medical devices have a CE marking, which certifies their compliance with MDR, will be able to continue placing their devices in the market in Great Britain until June 30, 2028, or June 30, 2030, depending on device classification and applicable legislation. The new UK Medical Device Regulations, when enacted, are likely to impose an additional regulatory burden for any products we intend to market in Great Britain, whereas we expect that Northern Ireland will remain subject to the MDR. In addition, the EU adopted the Clinical Trials Regulation, or Regulation 536/2014, or CTR, in April 2014, which became applicable on January 31, 2022. The CTR is directly applicable in all the EU member states, and repeals the Clinical Trials Directive. The CTR outlines a transitional timeline:

| • | from January 31, 2023 to January 31, 2025, ongoing clinical trials authorized under the Clinical Trials Directive can remain under the Clinical Trials Directive or can transition to the CTR. However, as of January 31, 2023, no   
 new national clinical trial applications can be submitted under the Clinical Trials Directive 2001/20/EC. Consequently, if the sponsor chose to submit the clinical trial application under the Clinical Trials Directive during the 
 one-year transition period which ended on January 31, 2023, a new EU member state can only be added to the clinical trial after January 31, 2023, once the entire clinical trial has been transferred to CTIS. Further, substantial  
 amendments to trials authorized under the Clinical Trials Directive are permitted until January 31, 2025; and by January 31, 2025, all ongoing clinical trials will be required to have transitioned to the CTR.                     |

The CTR harmonizes the assessment and supervision processes for clinical