Richard North, 23/01/2018  
 


I seem to recall that a number of people were rather strident in their dismissal of some of my warnings about the consequences of Brexit, claiming that I was exaggerating about some of the effects.

No more was this so than the potential fate of the group of CE marked products which require third party testing by so-called "Notified Bodies" before they can be freely circulated within the EEA.

A classic example is the so-called "hazardous area equipment" market, that equipment currently covered by Directive 2014/34/EU "on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres".

The crucial point about Notified Bodies is that they must be established in territories of the EU Member States, a situation that currently applies to UK bodies but lapses on Brexit. Thus, once we have left the EU, the concern was that the certification carried out by Notified Bodies located in the UK would no longer be valid.

Now, despite the protestations that I have been exaggerating, the European Commission has, in its latest "Notice to Stakeholders" have basically confirmed the situation – and some.

Referring to the rules "in the field of industrial products" and the "consequences for conformity assessment procedures and notified bodies", the Commission confirms that Union product legislation requires "Notified Bodies to be established in a Member State and be designated by a Member State notifying authority".

Therefore, it says, as from the withdrawal date, UK Notified Bodies will lose their status as EU Notified Bodies and will be removed from the Commission's information system on notified organisations (NANDO database16). As such, UK bodies will not be in a position to perform conformity assessment tasks pursuant to Union product legislation as from the withdrawal date.

The Commission goes on to say that, when the applicable conformity assessment procedure requires or provides for the possibility of third party intervention, a certificate delivered by a body recognised as an EU Notified Body at the time of the placing of that product on the market will be required for products placed on the market as from the withdrawal date.

Traders, otherwise known as "economic operators" are thus advised to take the necessary steps to ensure that, where the applicable conformity assessment procedures require the intervention of a Notified Body, they will hold certificates issued by an EU-27 Notified Body to demonstrate compliance for their products placed on the market as from the withdrawal date.

Where economic operators hold certificates issued by a UK Notified Body prior to the withdrawal date and plan to continue placing the product concerned on the EU-27 market as from the withdrawal date, they are advised to consider either applying for a new certificate issued by an EU-27 Notified Body.

Alternatively, they can arrange for a transfer – on the basis of a contractual arrangement between the manufacturer, the UK Notified Body, and the EU27 Notified Body - of the file and the corresponding certificate from the UK Notified Body. This would then be passed to an EU-27 Notified Body, which would take over the responsibility for that certificate.

The transfer process does provide something of a life saver for businesses which want to continue selling into the EU, although the bureaucracy is not straightforward and there are bound to be significant cost implications.

Furthermore, conformity assessment is big business so the transfer of so much work to EU Member States is bound to have job implications and represent a loss of economic activity.

What must also be borne in mind is the sheer scale of third party testing. Excluding specialist areas such as vehicle production and aviation, the scope of CE mark testing ranges from the general to the specific.

We thus have Directive 2001/95/EC on general product safety on the one hand, to restriction on the use of certain hazardous substances in electrical and electronic equipment, as covered by Directive 2011/65/EU.

Then there is Directive 2012/19/EU on waste electrical and electronic equipment, Directive 2006/66/EC on batteries and waste batteries, Directive 2009/142/EC covering appliances burning gaseous fuels, and ecodesign requirements for energy-related products covered by Directive 2009/125/EC.

Then there are specific product groups such as simple pressure vessels (Directive 2014/29/EU), toy safety (Directive 2009/48/EC) Electrical equipment designed for use within certain voltage limits (Directive 2014/35/EU), dangerous machinery (Directive 2006/42/EC), electromagnetic compatibility (Directive 2014/30/EU), measuring instruments (Directive 2014/32/EU) and non-automatic weighing instruments (Directive 2014/31/EU).

The full list is far too long to reproduce here, but one must also include cableway installations designed to carry persons, radio equipment, medical devices and active implantable medical devices (something, quite literally, close to my heart), in vitro diagnostic medical devices, cosmetics, aerosol dispensers, and lifts and safety components for lifts.

According to the Guardian, there are 200 UK Notified Bodies providing conformity assessment services, amongst them the British Standards Institute, which certifies high-end medical equipment such as MRIs, heart valves and artificial hips.

This organisation certifies 7,000 products a year and uses teams of specialists such as oncologists and bioengineers from around the world to assess new products.

It says the "Notice to Stakeholders" outlines the worst-case where no withdrawal agreement is achieved. It hopes the situation will be averted with the conclusion of mutual recognition agreements (MRA) on conformity assessment.

This is a distinct possibility that these agreements will to be made as they are a common component of trade agreements, although they cannot be concluded before we actually leave. And nor can it be guaranteed that all areas will be covered.

For instance, Union legislation on medical devices (Council Directive 93/42/EEC concerning medical devices and Council Directive 90/385/EEC concerning active implantable medical devices) obliges manufacturer to designate authorised representatives who are established in the Union. Therefore, certification will require an EU presence.

This notwithstanding, as alternative arrangements will take time, it will be absolutely essential that we have a transition period which allows for continued recognition of conformity assessment. Without that, there will have to be a wholesale transfer of business to EU-based bodies, without which the sale of many products currently traded will no longer be permitted.

And with that, the one thing for sure is that the problems we currently face would not have been an issue had Mrs May not decided to take us out of the Single Market. The loss of recognition of Notified Bodies is entirely a function of this ill-considered decision and is yet another example of Mrs May's chickens coming home to roost.






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