Brexit

What does it mean for our industry?

As the date of the UK’s withdrawal from the EU is rapidly approaching, we wanted to update our valued partners on the steps we have taken to prepare for Brexit.

We have been working behind the scenes to minimise any impact on our business operations and our progress so far includes, but is not limited to the following:

• We have increased stocks of key products
• We have alternate freight options
• We have access to an extensive global supply chain should we need it

Essilor International

Since 1849 the Essilor group philosophy has been that of designing and manufacturing high quality corrective vision lenses and frames which meet patient requirements all across the world.

Today Essilor employs 74,000 employees over 33 production sites and 449 Rx laboratories producing over 565 million lenses.

Essilor respects local requirements and aligns its operations with local compliance and regulatory requirements. Essilor manufacturing processes worldwide are homologated producing corrective vision lenses that meet the requirements of International and local safety requirements.

Essilor Ltd

Based in Thornbury since 1974 Essilor have produced lenses for the spectacles for the UK&I market. Our core ambitions to produce high quality lenses that are safe and correcting the sight of our customers.

Our extensive network of Labs across the world manufactures lenses to the highest quality and product and design patient safety and are fully compliant with UK and European requirements, these include the requirements to ISO 14889: 2013: Spectacle Lenses- Fundamental requirements for uncut finished lenses. ISO 21987: 2017 Mounted Spectacle Lenses and ISO 12312-1+A1: 2015 Eye and Face protection – Sunglasses for General Use

In 2020 Essilor Ltd achieved certification to ISO 13485: Quality Management systems for regulatory requirements to further demonstrate to our customers, current and future of our commitment to the manufacture and distribution of vision correction lenses, products and services.

Industry Overview

From 1st January 2021 the Medicines and Healthcare Products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system.
This guidance provides information on how the UK system will operate, including for:

Getting your device certified
Conformity marking your device
Registering your device with the MHRA

This guidance is divided into sections on the different rules that will apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland. For Northern Ireland, different rules will apply to those in Great Britain after the end of the transition period. For more information on the regulatory system for medical devices in Northern Ireland, please see ‘Regulation of medical devices in Northern Ireland '

This guidance only applies to medical devices and does not cover other CE marked products, which are subject to separate guidance.The proposals outlined in this guidance notice will take effect through legislative changes that will be introduced before the end of 2020.

This information is meant for guidance only. You should consider whether you need separate professional advice before making specific preparations. Speak to your trade association if you are unsure which regulatory framework.

Summary of key requirements for placing Spectacles in the Great Britain market

General overview for manufacturers and distributors:

From 1st January 2021, there will be a number of changes to how medical devices are placed on the market in Great Britain. These are:

CE marking will continue to be recognised in Great Britain until 30th June 2023
Certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30th June 2023
After the transition period, the EU will no longer recognise UK Notified Bodies
UK Notified Bodies will not be able to issue CE certificates (other than for the purposes of the “CE UKNI” marking, which will be valid in Northern Ireland) - and will become UK Approved Bodies from 1st January 2021
A new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from 1st January 2021
From 1st January 2021, all medical devices, including in vitro diagnostic medical devices (IVDs), placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering;
Class I devices, custom-made devices must be registered from 1st January 2020.

Legislation that will apply in Great Britain

Legislation from 1st January 2021

Currently, devices are regulated under:

Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
Directive 93/42/EEC on medical devices (EU MDD)
Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)

These directives are given effect in UK law through the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). These Regulations (in the form in which they exist on 1st January 2021) will continue to have effect in Great Britain after the transition period has ended.
This means that from 1st January 2021, the Great Britain route to market and UKCA marking requirements will continue to be based on the requirements derived from current EU legislation.

The role of the MHRA

The MHRA will continue to perform market surveillance of medical devices on the UK market and will be able to take decisions over the marketing and supply of devices in the UK.

The MHRA will continue to be responsible for the designation and monitoring of UK Conformity Assessment Bodies.

Further guidance is available on how the MHRA enforces the legislation on medical devices.

Optical practices as well as manufacturers and distributers must registered with the MHRA as they should now.

For more information on placing medical devices onto the UK market from January 1^st 2021.

https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021

Further information

For further information about Registrations in Great Britain, Labelling Requirements, Post-Market Surveillance and Vigilance, Regulation of Medical Devices in Northern Ireland, please click here.

Your questions answered

Brexit Q & A

Essilor Related Questions & Answers

Q: How strong is Essilor's supply chain?

A: Essilor's supply chain is robust and market leading in our industry. We have access to several sites in Europe and further afield which allow us to manage the complexity of our product offering. We can alternate between sites based on our needs as they change from time to time.

Q: Will my lenses take longer to arrive?

A: If there is a particular strain on all UK ports of entry it may cause some small disruption, however we do think that we have the systems and contingencies in place to manage any short term disruption. In particular we have increased stocks of lenses locally, sourced contingent freight supplies and have a global supply network which we can draw on as needed.

Q: Have you increased stock levels?

A: Yes, we have increased the stock holding of key products.

Q: Will the new import/export regulations affect my delivery ?

A: We have considered the increased administrative implications when shipping across borders with our last mile carriers and taken appropriate steps to ensure our shipments meet the import/export requirements. If there is a particular strain on country entry points it may cause some small disruption.

Q: Will Essilor be changing what product information they supply to us?

A: No the current information supplied meets current regulatory needs.

General Industry Questions & Answers

Q: Do I need to register my practice with the MHRA?

A: Yes, as a distributer of a medical device you will need (as you should be already) register your practice with the MHRA on their DORS page on the link below.
https://www.gov.uk/guidance/register-as-a-manufacturer-to-sell-medical-devices#making-changes-to-your-registration

Q: I assemble spectacles, will my registration change?

A: No your existing registration will apply, if you are unsure about your registration credentials seek advice.

Q: Will our business requirements terms and conditions alter?

A: At the moment there is no indication that you will need to change anything, however it is advisable you seek ongoing professional advice on legislation as it changes.

Q: Will the optical standards change; will we work to current ISO standards?

A: No there is no indication at this time that optical standards our industry use to validate product will change.
The UK is a member of the International Standard Committee so our EU status will not be compromised.

Q: As a lab will our operating requirements change?

A: This depends on your business and how it operates, repackaging and labelling for example, if you are a lab professional advice is recommended. More details on the full legislation can be found on the link below. At this time, we are unsure of the ISO standard that will be applicable, for now ISO 14889: 2013 remains the standard for lens and transmission conformance.
https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021?utm_source=8580e81d-1fe6-4d37-8e6a-ca3204d2dc8b&utm_medium=email&utm_campaign=govuk-notifications&utm_content=daily

Questions?

If you have any questions regarding brexit, please contact the customer service team on: