Continuing our programme of insights into post-Brexit challenges, this month we look at one issue facing product manufacturers and consider what steps they could consider taking in the lead up to Brexit.
Product conformity to established technical and quality standards is a hallmark of the EU product standardisation project. The adoption of harmonised standards for products such as toys, lifts, medical devices and construction products, to name a few, allows for free circulation of potentially highly sensitive goods while ensuring public safety in the Single Market.
To ensure that a product meets the prescribed standards, the EU has created a system where member states provide accreditation to “Notified Bodies” that in turn undertake conformity assessments for manufacturers and issue ‘CE’ marks to products that meet the standards, as well as undertaking mandatory quality audits.
The European Commission issued a Notice setting out the effect Britain’s withdrawal from the EU may have on product safety standards. Of particular concern will be the potential consequences to the system of conformity assessments. Simply put, EU legislation requires a Notified Body to be based in the EU, and consequently as of 00:00h on the 30th March 2019 the validity of hundreds of thousands of established UK conformity assessments may be called into question.
Taking just one sector in Scotland as an example, this may have a significant effect on over 600 life science and medical technology organisations based in Scotland that wish to trade in the EU.
The UK could continue to transpose and comply with EU product safety legislation, and UK Notified Bodies could be allowed to continue undertaking conformity assessments. An appetite for continuing to adopt laws from Brussels does not reflect UK Government policy statements to date. However, in a reflection of the ever shifting sands of the current negotiations, Theresa May has called for a comprehensive system of mutual recognition and a commitment to maintain UK regulatory standards in line with the EU’s. If and how that is achieved in practice is the question.
For now, it is possible manufacturers could be faced with instructing EU based notified bodies in order to maintain selling to the EU. Scottish companies will be aware of the difficulties of instructing notified bodies from a distance already. There exists only a small number of notified bodies based in Scotland. A Scottish Enterprise report found that Scottish companies already experience issues finding UK-based notified bodies to undertake conformity assessments, citing high costs and lengthy time frames.
Could these problems be exacerbated post-Brexit? This may be an area where Scottish and UK manufacturers could do some contingency planning. Manufacturers should consider:
- Do they produce CE marked products?
- Do they use CE marked components?
- Which Notified Body was involved?
- Does this Body have plans to move services to mainland EU; or should they transfer to a mainland EU Notified Body?
Of course, this is just one issue facing product manufacturers post-Brexit. It demonstrates the complexities of selling consumer products abroad, which are now thrown into sharp focus by the current debate.
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