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
SGS has well-established Medical Devices Notified Bodies within the EU 27, based in Belgium and Finland. For clients with Class I and II products, these will provide an effective solution for a transfer in most cases. Please contact your local customer service team for further information.
We are extending the scope of our Notified Body in SGS Belgium to cover Class III, but the timing of this is not within our control. We anticipate completion of the extension to scope exercise during Q3 2019 but cannot guarantee this. Once we have secured the extension to scope, clients will be able to transfer normally.
Customer contracts with the SGS United Kingdom Ltd Notified Body will continue and we will remain approved by our regulator, the MHRA. Our certificates will continue to be recognized in the UK market by the MHRA. Additionally, some Competent Authorities in mainland Europe, notably Switzerland and Netherlands, have announced that they will accept UK certification for at least a transitional period. We anticipate that the number of countries doing this will grow if a no-deal Brexit again becomes likely.
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.
- 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
- 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.