New MDR and IVDR leave Manufacturers in Doubt as guidelines issued for Northern Ireland
The EU MDR and IVDR applicable in NI from 26th May
Brexit has brought challenging times for all. COVID 19’s contribution towards market uncertainties overshadowed contributions from Brexit towards these uncertainties and now, based on the new guidance for Medical Devices in EU – Northern Ireland (Part of the United Kingdom), receives special requirements.
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 sets out specific requirements for Northern Ireland. Despite being in the United Kingdom, these requirements (MDR 2020) are set out differently for NI.
This differential treatment gives rise to confusion, questioning Why this differential treatment? Was it the exit of Great Britain only?
As we all know, the Medical Device Regulations (2017/745) (MDR) and the In Vitro Diagnostic Regulations (2017/746) (IVDR) will fully apply in the EU Member States from 26th May 2021 and 26th May 2022, respectively.
The Northern Ireland Protocol (applied on 1st January 2021) highlights different rules for placing medical devices on the NI Market than the markets of Great Britain (England, Wales and Scotland), where the MDR will apply in Northern Ireland from 26th May 2021 and the IVDR will apply in Northern Ireland from 26th May 2022, in line with the EU’s implementation timeline.
Guidance from the Government of the United Kingdom lists the following:
“If you are manufacturing or supplying a medical device, you must meet new obligations set out in the Regulations, including, but not limited to, ensuring that:
the device has been correctly classified against the new risk classification criteria (Annex VIII of the MDR and IVDR)
general safety and performance requirements are met, including for labelling, and technical documentation and quality management systems (Annex I of the MDR and IVDR)
increased requirements for clinical evidence are met (Annex XIV of the MDR and IVDR)
manufacturers have a person responsible for regulatory compliance in place (Article 15 of the MDR and IVDR)
as an importer, you meet the requirements set out in Article 13 of the MDR and IVDR
as a distributor, you meet the requirements set out in Article 14 of the MDR and IVDR.”
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