Requirements
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The following are extracts from government documents.
Medical device timelines as published by the UK government as of 17th February 2025.
Note that currently:
- You can place a general medical device self-declared to comply with EU MDD requirements on the Great Britain market if the declaration of conformity was made before 26th May 2021 and the declaration for that device remains valid for placing it on the EU (and NI) market under EU MDR transitional arrangements.
- You can place an IVD self-declared to comply with EU IVDD requirements on the Great Britain market if the declaration of conformity was made before 26 May 2022 and the declaration for that device remains valid for placing it on the EU (and NI) market under EU IVDR transitional arrangement.
- Since 26 May 2021, you need to meet EU MDR requirements (rather than EU MDD requirements) if self-declaring compliance with CE marking requirements for medical devices before placing them on the Great Britain market
- since 26 May 2022, you need to meet EU IVDR requirements (rather than EU IVDD requirements) if self-declaring compliance with CE marking requirements for IVDs before placing them on the Great Britain market
For clarity, by 'self-declarations' in this section we are referring to cases where, in order to place a medical device on the Great Britain market, manufacturers can rely on self-declarations of compliance with relevant regulatory requirements without certification from a notified body. Such self-declarations include declarations made in relation to system or procedure packs.
Compliance timelines
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The government has introduced measures that provide that CE-marked medical devices may be placed on the Great Britain market to the following timelines:
- general medical devices compliant with the EU MDD or EU AIMDD can be placed on the Great Britian market up until the sooner of exipry of certificate or 30 June 2028
- IVDs compliant with the EU IVDD can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030
- General medical devices, including custom-made devices, compliant with the EU MDR and IVDs compliant with the EU IVDR can be placed on the Great Britain market up until 30 June 2030
The above timelines will not apply to Class I medical devices and general IVDs under the EU directives, where the conformity assessment under the relevant directive and under the EU MDR or EU IVDR does not involve a notified body. Similarly, they will not include custom-made devices that are compliant with the EU MDD or EU AIMDD.
You can place self-delcared CE-marked Class I medical devices on the GB market beyond 30 June 2023 if they are:
- self-declared against EU MDR requirements (until 30 June 2030), or
- self-declared against MDD requirements before 26 May 2021 where notified body involvement in their assessment is not required under MDD but is under EU MDR (until 30 June 2028) - this includes unclassified devices and reusable surgical instruments
You can place a Class I medical device which has a sterile or measuring function with a valid MDD certificate on the GB market until 30 June 2028
For more details review the UK Government Documents:
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
Manufcatured equipment timelines
As published by the UK Government as of 17 May 2024
Legislation is now in force which enables the UKCA marking to be placed on a label affixed to the product or on a document accompanying the product until 11pm on 31 December 2027. This means that as of 1 January 2028, in most cases, you must affix the UKCA marking to the product itself or the packaging. The government intends to introduce legislation to allow the UKCA marking to be affixed in more flexible ways. Additional ways for this measure will be provided in due course, including which regulations it will apply to.
In some cases, for example, where the product is too small, the UKCA marking can be affixed to the data plate, packaging, a label affixed to the product or accompanying documentation. Please consult the sector-specific legislation that applies to your products for more information.
The UKCA marking must be clearly visible, legible, and indelible when you affix it to the product (or permitted alternatives). There are also rules about the size and dimensions of the UKCA marking. See the rules for using the UKCA image.
UKCA markings must only be placed on a product by you as the manufacturer, your authorised representative (where permitted in the relevant legislation), or if you are marketing the products under your name or trademark (for example, where you will take the responsibilities of the manufacturer, including affixing the UKCA marking).
When affixing the UKCA marking, you take full responsibility for conformity with the requirements of the relevant UK legislation.
For more details review the UK Government Documents:
https://www.gov.uk/guidance/using-the-ukca-marking#product-areas-covered-by-the-ukca-marking