Medical Devices Notified Bodies (UK Brexit)

Exit day is 31st October (this date is in a Statutory Instrument)

Yesterday (8th October) the MHRA updated its instructions on Notified Bodies.

Here

This link updates on notified bodies: UL International (UK) Ltd address, contact details and EC link updated, BSI Healthcare EC link added, SGS named contact updated and LRQA was removed from the list.

The link also has the published guidance on how medical devices will be regulated.

UK Temporary Import Tariff Regime (UK Brexit)

Exit day is 31st October (this date is in a Statutory Instrument)

Today (8th October) the UK republished it’s temporary Import Tariff Regime that will apply in a no-deal Brexit.

Here

[this Blog does not focus on Customs or VAT]

It is mostly unchanged from the March version. Three aspects have changes – affecting HGVs, bioethanol and clothing –

• lower tariffs on HGVs entering the UK market, striking a better balance between the needs of British producers and the SMEs that make up the UK haulage industry, ensuring that crucial fleet replacement programmes that help to lower carbon emissions can continue

• adjusted tariffs on bioethanol to retain support for UK producers, as the supply of this fuel is important to critical national infrastructure

• tariffs applied to additional clothing products to ensure the preferential access to the UK market currently available to developing countries (compared to other countries) is maintained.

Moving Goods from Ireland to Northern Ireland (Northern Ireland Brexit)

Exit day is 31st October (this date is in a Statutory instrument)

[this Blog does not focus on Customs or VAT, this post is made only because the changes are substantive]

Today HMRC updated (in a major way) and reissued its guidance on customs procedures applying in Northern Ireland.

Here

Goods moving between Ireland and Northern Ireland will face different procedures compared to other UK-EU trade.

You will not need to:

• get a customs agent or an Economic Operator Registration and Identification (EORI) number

• pay Customs Duty or make import or export declarations to HMRC

You should also consider advice issued by the Irish government about their requirements for goods moving into or out of Ireland.

This was the case in the March instructions (see Blog post then).

What is added is information about moving controlled and licensed goods, transitional simplified procedures and moving goods under transit.

HMRC also issued updated instructions on excise duty applying to exports to Ireland and imports from Ireland.

Export – here.

Import – here.

Customs and VAT processes in Northern Ireland will also change if there is an orderly exit. I will be issuing further Blog posts.

UKCA Mark (UK Brexit)

Exit day is 31st October (this is the date in a Statutory Instrument)

Please remember the UK is bringing in a new UKCA Mark, applicable after Exit day.

The Feb issued instructions on UKCA Mark are here.

This applies to certified goods sold in the UK.

Please follow the links carefully, as some goods will require the UKCA Mark immediately after Exit day.

Other goods will be able to continue with the CE Mark for a limited period.

UK Product Safety and Metrology (UK Brexit)

Exit day is 31st October (this date is in a Statutory Instrument)

Today, the UK Office for Product Safety & Standards re-issued with updates the March Instructions on Product Safety and Metrology.

This September document – UK Product Safety and Metrology Guidance in a ‘no deal’ Brexit – is here.

The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, as amended by the Product Safety, Metrology and Mutual Recognition Agreement (Amendment) (EU Exit) Regulations 2019, amend local law and retained EU Law, from Exit day.

These Brexit laws are in the subscribers’ Brexit Law List and consolidation is well underway – in the Brexit Consolidated Law List (next upload – start of October).

(1) The Brexit Law alters those legal provisions in UK regulations and retained EU law that would not work effectively when the UK leaves the EU without changes. The Brexit Law objective is to create a functioning regulated UK market.

(2) The safety and other technical requirements are not specifically changed, but processes are changed.

(3) Products lawfully placed on the EU market before the UK leaves the EU can continue to circulate in the UK (for a temporary period, consultation will occur before this period ends, and a new Brexit Law is required for the temporary period to end).

(4) Lawfully CE marked products will continue to be accepted by the UK, intended to be for a time limited period (see above).

(5) Products being placed on the UK market for the first time after the UK leaves the EU must meet the same technical requirements as before – but labelling or notification requirements will change.

(6) A new UK Conformity Assessed marking (“UKCA”) may be used for products that will be placed on the UK market where conformity assessment has been carried out by a UK approved body (formerly a notified body). This is because after Exit day, the EU no longer recognises UK based Notified Bodies and so they will become UK Approved Bodies. The UKCA mark is not yet set up.

(7) Products intended to be exported to the EU that require an independent third-party conformity assessment – this assessment must be carried out by an EU based Notified Body and the products must be ‘CE’ marked (where required) once they have been successfully assessed. After Exit day, this cannot be carried out by a UK Approved Body.

(8) Where currently allowed, UK manufacturers can continue to self-declare that products meet EU rules and place these products on either the UK or EU markets. [please recheck this with the EU import country]

(9) The UK will continue to recognise EU Notified Body conformity assessments, for a time limited period, so manufacturers and importers will still be able to place goods on the UK market lawfully bearing the CE marking where they have been assessed by an EU Notified Body (where required).

(10) The UK will publish a list of references to designated standards that will have the same function as harmonised standards and give presumption of conformity to legal requirements. On Exit day, these designated standards will be the same as the harmonised standards.

(11) When the UK leaves the EU, the role and responsibilities of the manufacturer will be unchanged. However, some UK businesses which bring products into the UK from an EEA State and who were previously “distributors” from Exit day become “importers” acquiring new legal duties, including complying with an enhanced set of requirements to check product compliance as well as to keep documentation and ensure their address appears on the product.

(12) There is an 18-month transitional period for these “new” importers during which they can put their details on documentation accompanying the product, rather than on the product itself. The same will apply to imports from Switzerland for certain products, for the same 18- month period.

(13) Cosmetic products that have the information of the EU responsible person on the container and packaging will be allowed on the UK market for 2 years after the UK leaves the EU, after which the container and packaging will need to bear the name and address of the UK responsible person.

(14) The EU will not have a transitional period and so UK manufacturers exporting to the EU will need immediately after Exit day to have the address of the relevant EU responsible person on the goods they are exporting.

Please read the September document carefully, and also re-check with the EU import country.

IP and Brexit (UK Brexit)

Exit day is 31st October (this day is set out in a Statutory Instrument)

This Blog does not post on intellectual property. But, in the interests of completeness, and because the matter of exhaustion of IP rights is a (possibly overlooked) aspect of the circulation of goods, this Blog post publicises the UK Intellectual Property Office (IPO) instructions on IP and Brexit (updated today 11th September).

Here

Extract

Intellectual property rights give rights holders the right to control distribution and re-sale of a product that is protected by IP after they have been put on the market.

Currently, exhaustion of IP rights occurs in the UK when an IP-protected good is placed on the market anywhere in the European Economic Area (EEA). This means that rights holders (such as the owner of a brand) may not prevent the movement of those goods within the EEA. These goods are known as parallel goods, which are genuine goods (that is not counterfeit).

While the UK remains a full member of the EU, intellectual property rights remain exhausted after the first sale of a good. This is with the right holders permission and within the territory of the European Economic Area (EEA).

If there is a no-deal, the UK will continue to recognise EEA exhaustion so the rules affecting imports of goods into the UK will not change. Goods placed on the market [in the EU], after the UK has exited the EU, will continue to be considered exhausted in the UK. This means that parallel imports of these genuine goods from the EEA to the UK will continue unaffected.

However, there may be restrictions on the parallel export of goods from the UK to the EEA. This is because goods placed on the UK market, after the UK has exited the EU, will not be considered exhausted in the EEA.

Businesses that wish to export IP-protected goods to the EEA that have already been legitimately put on the market in the UK, may need the rights holder’s consent. All businesses may wish to seek legal advice on how this arrangement could affect their business model or intellectual property rights.

Manufactured Goods (UK Brexit)

Exit day is 31st October (this is the date in a Statutory Instrument)

Yesterday (10th Sept) HMG re-published its instructions on Manufactured Goods.

Here

I did Blog post these instructions in March, note the UKCA mark. The UKCA mark is not available yet. CE marks will continue for a temporary period.

The Sept publication has an update reminder that Distributors will be Importers.

By now, everyone should be Brexit Ready.

The specific text re Importers – (note the EEA and Switzerland reference)

If you are currently a UK distributor, you need to confirm whether you or your supplier will become an ‘importer’ once the UK leaves the EU. This will usually be the case if you are the one bringing goods into the UK from the EU, EEA or Switzerland, and want to put them on the UK market after Brexit.

If you are becoming an ‘importer’ you will need to ensure you understand your legal obligations. You will need to make sure:

• goods are labelled with your company’s details, including your company’s name and a contact address (for 18 months after Brexit you can provide these details on the accompanying documentation rather than on the good itself)

• the correct conformity assessment procedures have been carried out and that any good you import carries the correct conformity markings

• the manufacturer has drawn up the correct technical documentation and complied with their labelling requirements

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

• you do not place a good you import on the market if you have reason to believe it does not conform with the relevant essential requirements