SGS Services & Brexit
BREXIT TODAY – 29 APRIL 2019
Delivering the Withdrawal Agreement negotiated with the EU remains the UK Government’s priority but neither SGS, nor any other Notified Body, can make any guarantees with respect to the future and the implications of Brexit.
At present, the EU has granted the UK an extended period for Brexit negotiations until 31 October 2019 and so the certification process is continuing as usual.
With regard to the future we anticipate the following possible scenarios:
- The UK/EU Withdrawal Agreement is ratified (or any amendment agreed) on or before 31 October 2019. In this case certification should then continue as usual during the Implementation Period which is likely to last until December 2020. It is hoped that Mutual Recognition Agreements (MRAs) will be agreed during this time to allow the continued functioning of UK Notified Bodies after December 2020; or
- Article 50 is revoked, and the UK remains in the EU; or
- The UK leaves the EU without a deal on or before 31 October 2019 in which case UK Notified Bodies will no longer be recognized by the EU and any UK-issued certificates will no longer be valid. This continues to be the position of the EU Commission in the event of a “no-deal” Brexit
ATEX, PPE, MID Machinery and RED
SGS in Finland (SGS Fimko) has been appointed as a Notified Body for ATEX, PPE and MID with its scope extended under Machinery and RED. This allows SGS to provide continued Notified Body approvals through its UK arm (SGS Baseefa and SGS United Kingdom Ltd) even in the event of a no-deal Brexit or no MRAs.
For further information, please contact:
- ATEX – Equipment and protective systems intended for use in potentially explosive atmospheres – Phil Oates, tel: +44 (0)1298 766627
- PPE – Personal Protective Equipment
- Article 10/Module B – Kelvin Shepherd, tel: +44 (0)1934 522917
- Article 11/Module C2/D – Kevin Foy, tel: +44 (0)776 8408545
- MID – Measurement Instruments Directive, 2014/32/EU – Zee Ellahi, tel: +44 (0)191 377 2000
- MD – Machinery Directive, 2006/42/EC – Zee Ellahi, tel: +44 (0)191 377 2000
- RED – Radio Equipment Directive, 2014/53/EU – Zee Ellahi, tel: +44 (0)191 377 2000
- EMC – Electromagnetic Compatibility, 2014/30/EU – Zee Ellahi, tel: +44 (0)191 377 2000
- PED – Pressure Equipment Directive – Mark Homer, tel: +44 (0)121 541 4717
- TPED – Transport Pressure Equipment Directive – Mark Homer, tel: +44 (0)121 541 4717
- SPVD – Simple Pressure Vessel Directive – Mark Homer, tel: +44 (0)121 541 4717
Medical Devices Update – 30 August, 2019
The EU position has always been that, in the event of no-deal, UK-issued certificates will cease to have validity in the EU. However, several jurisdictions (including Netherlands and Switzerland) have already announced they will continue to recognize UK certificates for a transitional period and it is likely others will have to follow suit. The advice from the MHRA is for customers to contact the Competent Authorities in the countries to which they export for specific updates.
UK certificates will continue to be valid in the UK and we will continue our normal certification activities unless instructed otherwise by our clients.
In the event of a no-deal, the MHRA has announced it will seek to establish a new stand-alone regulatory mechanism within 6-9 months, independent of the CE-process. As one of only two remaining UK-based Notified Bodies, SGS would expect to be one of the initial certification bodies for this new requirement.
Clients who have not yet transferred to our Notified Body in SGS Belgium are invited to do so. Most of our clients fall within our existing scope and we would hope to be able to complete the transfer in advance of the Brexit deadline, although this cannot be guaranteed. Transfer requests must be initiated by individual clients, there is no automatic transfer process.
Clients who deal solely within the UK will not need to transfer unless they are aware of other influences which they need to address.
For clients that are not in our existing Scope in Belgium, we continue to work through the local Competent Authority to achieve an Extension to Scope. However, we have never been able to guarantee that will be achieved before the Brexit deadline and our advice remains that affected clients should review their own assessment of the risks to their business from a hard Brexit in light of this.
The New UK Mark
The UK Government have communicated its intention to create a new UK mark and has confirmed that all current UK Notified Bodies will transfer as Approved Bodies for the new scheme. This does not apply to Medical Devices or Transportable Pressure Equipment, but the UK Government has confirmed that all other sectors will transfer automatically in the event of a hard Brexit.
For companies selling only into the UK, this will remove the need to seek EU notification and very quickly provide a route to market in the UK for new products.
For Medical Devices, the MHRA has announced that a new UK scheme would follow rapidly in the event of a no-deal Brexit, but further details of the nature of this scheme are not yet available.
MAINTAINING MOVEMENT OF GOODS
A major area of concern for many of our customers are the future arrangements governing the physical movement of goods across European borders. Again, we want to assure our customers that we are working closely with our European Affiliates to ensure we will have in place an effective network that can deliver whatever documentation and certification requirements are required for the movement of goods post-Brexit.
BREXIT RESOURCES AND UPDATES
Please visit this section regularly to keep up to date with the latest guidance and updates.
- Information for the Health and Care Sector
- EU Exit and UK Conformity Assessment Bodies (PDF 474 KB)
- Brexit Key Questions March 2019 (PDF 602 KB)
- BEIS Letter of Approved Bodies Update (PDF 245 KB)
- Regulating Medical Devices in the Event of a no Deal Scenario
- Questions & Answers Related to the UK's withdrawal from the European Union (PDF 387 KB)
- Trading Goods Regulated Under the New Approach if there's no Brexit Deal (PDF 93 KB)
- Brexit Guidance: MHRA Outlines What to Expect
- UKAS: Withdrawal of the UK and EU rules in the field of industrial products
- Preparing for a no-deal: the impact on Industrial products
- The European Chemicals Agency (ECHA): Leaving the EU
Technical notices concerning the regulation of chemicals in the UK in a no-deal scenario:
- Classification, Labelling and Packaging (CLP) regulation - No-deal Brexit
- Biocidal Products Regulation (BPR) - No-deal Brexit
- Plant Protection Products (PPP) regulation - No-deal Brexit
- Prior Informed Consent (PIC) regulation - No-deal Brexit
- Regulation on mercury - No-deal Brexit
- Regulating Persistent Organic Pollutants (POPs) - No-deal Brexit
Updates from SGS:
- Continuity of Construction Product Regulation (CPR) certification (PDF 177.9 KB)
- Medical Devices: Brexit Update
Don’t second guess the future
Check current trade with EU countries. Prepare for the transition period, and beyond.