News, Policy & Media

28Jan

EU publishes IVDR transitional period extensions into law

The amending regulation which extends the transitional provisions of the IVD Regulation has become EU law and comes into force from today. This is immediately applicable in all member states, and will allow for further preparation time for companies depending on device classification.

Regulation (EU) 2022/112 extends the IVDR transitional periods, allowing most devices with their EC Declaration of Conformity under the IVD Directive to be placed on the market and or put into service for an additional timeframe of 3-6 years depending on their appropriate risk class under the IVDR.

A sell-off provision is provided for devices which have already entered the supply chain before the end of their transitional period. Certain requirements under IVDR Article 5.5 are also postponed for health institutions (laboratories) which manufacture and use ‘in house assays’.

**Please note that the 26 May 2022 date of application of the IVD Regulation remains unchanged.

Devices which are Class A non-sterile must have obtained CE marking under the IVDR from the date of application. New’ devices will need CE-marking under the IVDR after date of application.

The full amended regulation is available for your reference here.

Related

Following on from the latest HMG webinar, officials have put together an FAQ answering questions rai...

Read More >

Government has said that it has reached its target of having a capacity to carry out 500,000 tests p...

Read More >

The Government’s Health and Social Care Committee have issued a warning that NHS England is no...

Read More >

Medical aid and equipment being sent to India from the United Kingdom has arrived today as the count...

Read More >

The Department of Health is pleased to announce that the Procurement Transformation Programme (PTP) ...

Read More >

A call for evidence has been launched by the Health and Care Select Committee regarding a planned in...

Read More >