New rules for placing manufactured goods on the market from 1st January 2021
With the transition period nearly over and with some aspects still to be decided, there are some very clear rules we must all be prepared for.
If you currently manufacture goods, you will need to comply with rules for both the EU and the UK.
Placing manufactured goods on the EU market from 1 January 2021
What you will need to do from 1 January 2021 depends on the type of goods you’re placing on the market.
There are different rules for:
- goods regulated under the old approach (such as chemicals, medicines and vehicles)
- non-harmonised goods covered by national legislation
If you’re unsure which applies to your goods, contact the BPMA for guidance.
Old approach goods
You must follow special rules if you’re placing these goods on the EU market.
Check the European Commission’s website for the latest information.
Non-harmonised goods
You must make sure that your goods meet the requirements of the first EU or EEA country in which you are placing them on the market.
Check the national regulations of the relevant EU/EEA country to find out what you need to do.
Check if you need to change your conformity assessment
You will not need to change your conformity assessment for exports to the EU if:
- you self-declare the conformity of your good against the regulations
- any mandatory third-party conformity assessment was carried out by an EU-recognised notified body (whether based in the EU or in a country with which the EU has a mutual recognition agreement)
- the certificate of conformity previously held by a UK body has been transferred to an EU-recognised notified body
- you voluntarily use a testing body (including UK bodies) to test against European or international standards
UK conformity assessment
From 1 January 2021 any mandatory conformity assessment will need to be carried out by an EU-recognised conformity assessment body. This includes both EU based bodies and bodies in countries with which the EU has concluded a mutual recognition agreement.
UK conformity assessment bodies will no longer be able to carry out mandatory conformity assessment for products being placed on the EU market unless agreed in negotiations.
Speak to your testing body or solicitor for advice on how conformity processes for your good will be affected from 1 January 2021.
For more information on placing goods in the EU, visit UK Gov’s website here.
Placing manufactured goods on the market in Great Britain from 1 January 2021
If you have already placed your good on the UK market (or in an EU country) before 1 January 2021, you do not need to do anything.
We have been advised that businesses are encouraged to be ready for full implementation of the new UK regime as soon as possible after 1 January 2021. However, to allow businesses time to adjust, CE marked goods in scope of this guidance that meet EU requirements (where these match UK requirements) can continue to be placed on the GB market until 1 January 2022 where EU and UK requirements remain the same. This includes goods which have been assessed by an EU recognised notified body. There are some exceptions to this guidance, highlighted below.
Check which rules apply
What you will need to do from 1 January 2021 depends on the type of goods you’re placing on the market.
Most of this page covers goods often known as new approach goods.
There are different rules for:
- goods regulated under the old approach
- goods covered by national rules (non-harmonised)
- certain other goods, such as medical devices and civil explosives
Talk to the BPMA if you are unsure about how your goods might be regulated if you are unsure.
Relevant to the industry; with Old approach goods you must follow different rules if you’re placing the following goods on the UK market:
Other goods
There are also special rules if you’re placing the following goods on the UK market which may apply if you are involved in the supply of PPE.
Check if you need to change your conformity assessment or marking
You need to use a conformity mark if you’re placing certain goods on the UK market. Before 1 January 2021 you can do this using the CE mark or other appropriate mark (such as the wheel marking or Pi mark).
From 1 January 2021, the UKCA mark will be the conformity assessment marking for Great Britain for most goods currently subject to CE marking.
The CE marking will be accepted in the UK until 1 January 2022 for certain products. You must be ready to use the UKCA marking from 1 January 2022 at the latest, although you should look to use the UKCA marking as soon as possible.
Please visit UK Gov site for more details and see the further articles in this newsletter on UKCA marking.
