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Safety Conformance & Compliance Issues in the Event of ‘No Deal’

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BSIF have issued a technical paper covering plans for the sector in the event of a ‘no deal’ exit from the EU. While this scenario is unlikely as the government expect to secure a deal, BSIF wish to prepare for all possible eventualities. The BSIF will continue to lobby hard for a Mutual Recognition Agreement (MRA) to be put in place.

The Highwire Team thought it would be helpful to put together a summary of the paper’s key points.

BSIF technical paper – Key Points:

  1. The EU will no longer recognise the results of conformity assessment carried out by UK notified bodies. Products tested by a UK notified body will no longer be able to be placed on the EU market. Products must be retested and re-marked by an EU recognised conformity assessment body. Prior to sale in the EU, all UK-certified PPE certified will need to be re-certified by an EU notified body.
  2. To sell PPE in the EU, manufacturers will be able to transfer their files to an EU-recognised notified body. This will allow for certificates of conformity issued by a UK body to continue to be valid.
  3. The UK’s essential requirements would be identical to EU essential requirements immediately after exit day. All existing harmonised standards would become UK ‘designated standards’. The UK will also create a new conformity marking. However, in the period after exit day, an EU compliance mark will be sufficient for products sold in the UK.
  4. The UK will continue to accept products which have been certified in any EU country. No retesting will be necessary.
  5. The EU will no longer recognise UK-based nominated persons. The UK will continue to recognise EU-based representatives for a short period.
  6. To place goods on the EU market, you will need an EU-based representative. If you only have an EU-based representative, and you wish to place goods on the UK market, in the long run, you will need a UK-based representative.

In Summary

Whilst it is likely that parallel but separate systems will mean extra costs to comply, further information will be provided by the government later this year. The aim will be to set out practical arrangements for how UK-based notified bodies will be granted a new status as UK ‘approved bodies’. The government will also specify the new UK markings.

If you would like to read up further on this subject, you will find links to the notices below:

Trading goods regulated under the ‘New Approach’
Trading under the mutual recognition principle
Appointing nominated persons to your business

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