Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 93

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 93
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 to data exclusivity in Europe, with the effect of potentially reducing the period of data exclusivity available to the Company in Europe. 48 Table of Contents Legislation changes may also affect the legal requirements under which we perform our technical, nonclinical and clinical development of our product candidates and the medical devices required to deliver such product candidates, and they may affect how the FDA, EMA and comparable foreign regulatory agencies review and approve new drug products, drug-device combination products or medical devices. For example, on April 5, 2017, the European Parliament passed the MDR, which repeals and replaces the EU Medical Devices Directive and the Active Implantable Medical Devices Directive. Unlike directives, which must be implemented into the national laws of the EEA member states, the regulations would be directly applicable, i.e., without the need for adoption of EEA member state laws implementing them, in all EEA member states and are intended to eliminate current differences in the regulation of medical devices among EEA member states. The MDR, among other things, is intended to establish a uniform, transparent, predictable and sustainable regulatory framework across the EEA for medical devices and ensure a high level of safety and health while supporting innovation. The MDR became fully applicable on May 26, 2021, after a three-year transition period. This regulation, among other things:

| • | strengthens the rules on placing medical devices on the market and reinforce surveillance once they are available; |

| • | establishes explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of medical devices placed on the market; |

| • | improves the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number; |

| • | sets up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU; and |

| • | strengthens rules for the assessment of certain high-risk medical devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market. |

These modifications may have a significant effect on the way we can develop our product candidates and the medical devices required to deliver such product candidates, and may delay our development significantly. On March 20, 2023, Regulation (EU) 2023/607 entered into force, which extended the transitional provisions of the MDR as follows:

| • | 2026 for class III custom made devices; |

| • | 2027 for class III and