Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices
1. On 15 October 2021 the EU Commission shared the Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/746 (EU IVDR) as regards transitional provisions for certain in vitro diagnostic medical devices (IVDs) and deferred application of requirements for in-house devices.
2. The proposal is to amend the EU IVDR to extend the transitional periods, introduce additional transitional provisions, and defer the application of its provisions concerning in-house devices. It is not looking to impose new requirements. It aims to address concerns that a shortage of notified body capacity could lead to disruption in supply of IVDs, and to ensure parties are in a position to implement EU IVDR, taking into account the magnitude of the COVID-19 pandemic.
3. As the proposal sets out, the EU IVDR establishes a new regulatory framework for IVDs, such as HIV tests, pregnancy tests and COVID-19 tests. The EU IVDR increase the types of in vitro diagnostic medical devices (IVDs) requiring assessment by independent conformity assessment bodies (designated as “notified bodies”) before they are placed on the market. The EU IVDR will apply in Northern Ireland from 26 May 2022 but will not apply in Great Britain.
The proposal sets out that, given the challenges presented by the COVID-19 pandemic and associated public health crisis and lack of notified bodies capacity, it is very likely relevant actors will not be ready or able to implement EU IVDR on time. The European Commission anticipates that, unaddressed, this situation would lead to a significant disruption in the supply of IVDs on the market.