Medical Devices Regulation Delay (Britain)

On 26 June 2022, the MHRA published the government response to the public consultation it had held on the future regulation of medical devices in the UK.

In a decision published 25 October 2022, the UK government has stated it will introduce a 12 month extension to the implementation of the future Medical Device Regulations, with the aim to bring the new regulations into force by July 2024.

The UK government has previously stated it intends to bring in new Medical Devices Regulations as a substantial reform of the current framework in Britain.

On the EU side, EU MDR (European Regulation 2017/745) came into force on 26 May 2021 after the UK had exited the EU. The EU MDR is significantly longer and more rigorous than the MDD (European Directive 93/42/EEC) it replaced. EU MDR does not apply in Britain. EU MDR does apply in Northern Ireland from 26 May 2021. Similarly, the related EU IVDR (in vitro Diagnostic Medical Device Regulations) has applied in Northern Ireland from 26 May 2022.

On the UK side, the current Medical Device Regulations 2002 (UK MDR 2002) which implemented the pre 31 Dec 2020 EU MDD, as amended by Brexit law following the UK’s exit from the EU, states that the acceptance of CE marked devices in Britain ends on 30 June 2023.

The UK government intends to introduce new legislation by Spring 2023. Manufacturers will be able to place CE marked devices on the British market after 1 July 2023. From July 2024, transitional arrangements will apply for CE and UKCA marked devices placed on the British market.

The current guidance “Regulating Medical Devices in the UK” which is listed in the Brexit Guidance List on Cardinal Environment Limited EHS Registers and Checklists will be updated.

UKCA Marking Further Delay (Britain)

On 14th November the BEIS department of the UK Government laid before Parliament a further draft Statutory Instrument “Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022. The earlier draft instrument (I reported on by Email Alert a while back) is not proceeded.

The main purposes of this new instrument are to:

(1) extend acceptance of certain products meeting EU requirements and markings on the market in Britain for a further 2 years, until 31 December 2024, and

(2) as previously announced on 20 June 2022 (see my earlier blog post), but with updated timelines –

* provide that where manufacturers, or other relevant persons, have acted under EU conformity assessment procedures by 31 December 2024, that action will be treated as having been taken under the UK conformity assessment procedures until the expiry of the certificate, or until 31 December 2027, whichever is sooner

* extend existing labelling provisions for UKCA marking, importer information and responsible persons’ information until 31 December 2027.

There are different rules for medical devices, construction products, cableways, transportable pressure equipment, unmanned aircraft systems, rail products, cosmetics, and marine equipment.

There are different rules for Northern Ireland.

I will update Cardinal Environment Limited EHS Registers and Checklists. This matter will also be in the next Email Alert.

UKCA marking (Britain)

The UK Conformity Assessed (UKCA) mark is the new mandatory mark on a large number of manufactured goods to indicate that they conform to legislation enacted in Westminster for Britain (GB).

Businesses have until 1 January 2023 to start using UKCA marking which replaces EU marking.

On 20th June 2022, the then UK government announced that conformity assessment activities undertaken by EU bodies before the end of 2022 would be considered as the basis for UKCA marking in 2023.

That UK government announced that legislation on this would be brought forward before the end of 2022 to enable manufacturers to apply the UKCA mark on these products without the need for re-testing.

The purpose of this new legislation (if enacted) would be to allow CE marked products that are manufactured and imported into the UK by the end of 2022 to be sold, without the need to meet UKCA requirements. This would remove the current need for retesting and recertification for products that are imported whilst the UK recognised CE requirements. 

The 20th June 2022 announcement also states the UK would continue to accept spares onto the GB market which comply with the same requirements that were in place at the time the original products or systems they were being used to repair, replace or maintain were placed on the market.

Legislation would also be brought forward to extend current labelling easements to allow important information and other UKCA markings to be added to products using a sticky label or an accompanying document.

In addition, the 20th June 2022 announcement states that manufacturers of construction products under AVCP system 3 – such as radiators, sealants and tile adhesives – whose products are tested by an EU notified body before 1 January 2023 would be able to obtain a UKCA mark without having to retest through a UK-approved body.

The 20th June 2022 announcement is here.

The business sectors that these measures apply to include:

• aerosols

• electrical and electronics

• equipment for explosive atmospheres

• pyrotechnics

• gas appliances

• lifts

• machinery

• outdoor equipment

• personal protective equipment

• toys

• pressure equipment

• civil explosives

• recreational craft

There are different rules for:

• medical devices

• construction products

• cableways

• transportable pressure equipment

• unmanned aircraft systems

• rail products

• marine equipment

Further Border Control Delays (UK)

The UK government recently announced that movement of goods from GB to Northern Ireland (occurring under the grace arrangements in the Northern Ireland Protocol – NIP) would continue in the current manner indefinitely.

The UK government also recently announced that CE marked goods would continue to circulate in GB for the entire 2022. CE marked goods circulate in Northern Ireland by virtue of the NIP. This was included in the August Email Alert.

This morning, the UK government confirmed – here

• The requirement for pre-notification of agri-food imports will be introduced on 1 January 2022 as opposed to 1 October 2021.

• The new requirements for Export Health Certificates, which were due to be introduced on 1 October 2021, will now be introduced on 1 July 2022.

• Phytosanitary Certificates and physical checks on SPS goods at Border Control Posts, due to be introduced on 1 January 2022, will now be introduced on 1 July 2022.

• The requirement for Safety and Security declarations on imports will be introduced as of 1 July 2022 as opposed to 1 January 2022.

The timetable for the removal of the current easements in relation to full customs controls and the introduction of customs checks remains unchanged from the planned 1 January 2022.

UKCA and UKNI marks (UK)

The European CE mark is being phased out in the UK. Various deadlines apply to the situation where no CE marked good may be imported into the UK market unless it has been re-marked as UKCA.

A special situation exists in Northern Ireland – the Ireland/Northern Ireland Protocol allows European CE marking to continue to be used in Northern Ireland. The alternative UK mark to be used in Northern Ireland is UKNI, not UKCA.

A vast number of CE marked goods are in regular use in the UK. All businesses and individuals operating in the UK must assess their future requirements for CE marked goods and take steps to ensure their timely delivery before deadlines kick in.

Please check with suppliers and BEIS (the government department) on the current availability of already imported CE marked goods, and the deadline for a particular CE marked good.

Not all local assessment processes are set up, and deadlines may change. Further information is likely – please pay close attention to Email Alerts and Blog posts in the autumn.

[Not all European goods use the CE mark, I posted earlier about consultation underway on the timings for the phaseout of European marked Transportable Pressure Equipment – TPE – European sourced TPE has a different European mark]

Placing Manufactured Goods on EU market (UK)

The UK is churning out updated Brexit Guidance, we will be updating today (Christmas Day) the Brexit Guidance List on Cardinal Environment EHS Legislation Registers & Checklists – please look later today or tomorrow morning.

Re CE marked manufactured goods – the instructions confirm – 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 (this is not the UK).

UK conformity assessment bodies will no longer be able to carry out mandatory conformity assessment for products being placed on the EU market.

The legal text for the EU-UK trade and cooperation agreement is not yet published, documents issued so far by the EU and the UK indicate only medicinal products are covered by mutual recognition. Medicinal products are not CE marked goods.

If you have an EU based distributor they will become an ‘importer’ from 1 January 2021.

They will need to make sure:

• goods are labelled with their address and either your details or your EU, EEA or Norther Ireland-based authorised representative’s details (including your company’s name and a contact address or registered trademark)

• the correct conformity assessment procedures have been carried out and that goods have the correct conformity markings

• you, as the manufacturer, have drawn up the correct technical documentation and complied with the labelling requirements

• they maintain a copy of the declaration of conformity for a period of 10 years

• goods conform with the relevant essential requirements.

Details are here.

Office for Product Safety and Standards (UK from 1st Jan)

The Office for Product Safety and Standards (OPSS) has published guidance for businesses in Great Britain (GB) and separately in Northern Ireland (NI).

The guidance is issued separately (for GB and NI) – here – for the following –

(1) General Product Safety

(2) ATEX

(3) Cosmetics

(4) Electrics and electronics

(5) Gas appliances

(6) Lifts

(7) Machinery

(8) Metrology (weights and measures)

(9) Outdoor equipment

(10) Pressure equipment

(11) Recreational craft

(13) Toys

Guidance (Brexit) in these areas was issued in earlier years, but these documents are a fresh issue, and will be added imminently to the Brexit Guidance List in subscribers’ EHS Legislation Registers & Checklists online.

The Implementation or Transition Period officially ends at 11pm on 31 December 2020; therefore references to 1 January 2021 should be read as meaning 11pm on 31st December 2020.

Great Britain

The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, and other Brexit Law, that are being consolidated into domestic law – the Brexit Consolidated Law List in subscribers’ EHS Legislation Registers & Checklists) are also amended by the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 – which are not yet approved by Parliament.

This (as yet not approved amendment) provides for a 24 month transition period for importer labelling (for goods from the EEA), and the UKCA marking. It also amends the definition of “authorised representative” as well as introduces an end (in 12 months from the end of the Transition Period) to the recognition of goods meeting EU requirements, as well as introduces provisions for qualifying Northern Ireland goods.

Northern Ireland

Only a few of these guides are yet published.

UKCA Mark (UK from 1st Jan 2021)

On 1st September, the UK issued instructions for manufactured goods (and some other classes of goods), together with instructions on the UKCA mark applicable from 1st Jan 2021.

The UKCA mark instructions are here.

The instructions for manufactured goods are here.

The instructions for medical devices are here (note CE marked goods can circulate in GB until 30 June 2023).

The instructions for construction products are here.

The instructions for explosives are here. (HSE)

The instructions for rail interoperability are here. (dating from 1st July 2020)

UKCA (UK Conformity Assessed) marking is a new UK product marking that will be used for goods being placed on the market in Great Britain (England, Wales and Scotland). It covers most goods which previously required the CE marking, and aerosol products. I Blog posted some time ago about UKCA marking coming in.

UKCA marking alone cannot be used for goods placed on the Northern Ireland market, which will continue to require CE marking or UK(NI) marking.

The technical requirements (‘essential requirements’) and the conformity assessment processes and standards that can be used to demonstrate conformity – will be largely the same from 1st Jan 2021 as they are now.

UKCA marking can be used from 1 January 2021. However, CE marking will be permitted until 1 January 2022 in most cases.

CE marking will only be valid in Great Britain for areas where GB and EU rules remain the same. If the EU changes its rules and the product carries the CE mark on the basis of those new rules, CE marking will not be permitted for sales in Great Britain even before 31 December 2021. Please look out for Blog posts.

UKCA marking will not be recognised on the EU market. Products currently requiring a CE marking will need a CE marking for sale in the EU from 1 January 2021. [note from 1 Jan 2021, CE marks must be issued by legal entities based in the EU]

UKCA marking does not apply to existing stock, for example if the good was fully manufactured and ready to place on the market before 1 Jan 2021. In these cases the good can be sold in Great Britain with a CE marking even if covered by a certificate of conformity issued by a UK body.

On 1 Jan 2021 UK standards will be the same in substance and with the same reference as the standards used in the EU. However, they will use the prefix ‘BS’ to indicate that they are standards adopted by the British Standards Institution as the UK’s national standards body.

From 1 Jan 2022, CE marks will not be recognised in Great Britain for areas covered by the UKCA mark instructions and the UKCA marking. However, a product bearing the CE marking would still be valid for sale in the UK so long as it was also UKCA marked and complied with the relevant UK rules. Separate rules apply to medical devices (see the link above).

Product areas covered by the UKCA marking

• Toy safety

• Recreational craft and personal watercraft

• Simple pressure vessels

• Electromagnetic compatibility

• Non-automatic weighing instruments

• Measuring instruments

• Lifts

• ATEX

• Radio equipment

• Pressure equipment

• Personal protective equipment

• Gas appliances

• Machinery

• Outdoor noise

• Ecodesign

• Aerosols

• Low voltage electrical equipment

• Restriction of hazardous substances

All enquiries should be to BEIS.

This is a summary, please follow the links and read the instructions in full.

EU Law in UK 2021 (UK Brexit)

Exit day is 31st January (end of this month)

Implementation period completion day is 31st December (this is the end of the transition period)

The Chancellor speaking to the Financial Times, confirms there will be no dynamic alignment with EU Law after 2020.

I am not yet clear which laws will diverge, but please note the Brexit laws allow divergence, for example the Brexit Agriculture Bill provides for England, Wales and Northern Ireland to create their own marketing standards (Scotland will need to enact its own Brexit Agriculture Bill).

The EU Exit regulations (statutory instruments) we (Cardinal Environment) are consolidating into domestic law only deal with the pre-Brexit period to end Dec 2020.

It is the FT front page today (Saturday 18th January) and the lead on BBC online.

EU Law per se will not apply anyway. Note, there may be some long tail implementation left over from pre-Brexit that will be implemented.

We (Cardinal Environment) are already consolidating the EU Exit regulations into domestic law, and creating the Retained EU Law (EU Regulations, not Directives, that are adopted). Progress in this project can be seen by clicking the Brexit Consolidated Law List on the top right hand side of EHS Legislation Registers & Checklists homepages (both ENV and OHS).

We are working to the deadline of 31st December 2020 for completion of this project.

In addition, EHS Legislation Registers & Checklists will see the home page choice of ENV or OHS have additional Post-Brexit choices, and the existing links relabelled Pre-Brexit.

The Post-Brexit links will direct to shadow Registers & Checklists that will run from the end of Q1 to hit the end Dec 2020 deadline, for switch over to Post-Brexit.

Post-Brexit shadow Registers & Checklists running in 2020 will have Brexit Consolidated Law loaded (accessibility will stay from the main Brexit Consolidated Law list), and will display a changed Register layout.

Post-Brexit EHS Legislation Registers layout – EU Law will be moved from the top to below Guidance. We will still supply up to date EU Law to UK customers, but this is where it will be found. Retained EU Law will be displayed at the top of the Register.

EU Law in UK 2020 (UK Brexit)

UPDATE (24th Jan) : UK Policy is NOT to implement beyond the Implementation period completion day

Exit day is 31st January (end of this month)

Implementation period completion day is 31st December (this is the end of the transition period)

The Withdrawal Agreement agreed between the UK and the EU in November 2019 will be ratified in the UK and the EU imminently. This will bring about an ordered UK exit from the EU, and initiate a Transition Period.

The Transition Period will operate for 2020. During the Transition Period EU law enacted and in force by 31st December 2020 will be implemented in the UK, even if it has implementation deadlines after 31st December.

UPDATE (24th Jan) : For our purposes, this means the 2018 EU Circular Waste Economy Package will be implemented in the UK. The 2019 EU Single-Use Plastics Directive would not be implemented.

In addition, EU laws already implemented in the UK but with long tail deadlines for e.g. product bans (e.g. menthol cigarettes) that apply after Exit day or after Implementation period completion day, will still apply in the UK.

The envisaged purpose of the Transition Period is for the UK and the EU to agree alternative arrangements for trade in goods, primarily, that will subsist from 1st January 2021.

For our purposes, this means the new UK chemicals regime, the new UK medicines regime, the new UK equipment label (UKCA Mark), and UK issued certificates of all kinds, will need to be in place by end of 2020. Expect unilateral arrangements for EU goods and chemicals etc circulation in the UK for a limited period after 31st December 2020. I Blog posted a few days ago about hops and the later date available for circulation of EU hops in the UK.

There could also be unilateral arrangements on the EU side for limited time-length goods circulation in the EU.

A key issue is acceptance on both sides of certificates issued, and the matter of double testing for chemicals, medicines etc.