Equipment for use in potentially explosive atmospheres in the EU has to meet the requirements of the ATEX Directive 2014/34/EU:
As one might expect given the nature of the risk, the requisite conformity assessment procedures for such equipment generally includes involvement by a third party Notified Party. The only exception is Category II.c, where only a ‘normal’ level of protection is required, and the probability of an explosive atmosphere is low (Annex I, 2.c):
Article 13.1.c of the Directive specifies that such lower risk equipment can be assessed by ‘internal production control’ as set out in Annex VIII:
with ‘internal’ signifying that the responsibility for ensuring that the products comply with the legislation rests upon the manufacturer alone (or an authorised representative with respect to CE marking and the administrative tasks of VIII.4):
All the other conformity assessment modules incorporate Notified Body responsibilities. For example, in Module B, ‘EU type examination’, which is a prerequisite also for the series production Modules D, F, C1 and E, it is the Notified Body which examines and verifies the technical design of a product:
So long as the Notified Body is satisfied that the technical design meets the requirements, it issues an EU type 1 examination certificate to the manufacturer:
Two of the Modules, D and E, require the manufacturer to operate an ‘approved quality system’, either for both production and the product (Module D), or for the product only (Module E), which is to be assessed by a Notified Body. Here is Module D as an example:
After an audit, the Notified Body notifies its decision to the manufacturer (Annex IV.3.3) who, if successful, receives a Quality Assurance Notification:
Article 13(1)(b)(ii) provides that for equipment which is neither electrical nor an internal combustion engine, and is required to ensure a ‘high’ level of protection (between ‘very high’ or ‘normal’), the Annex VIII ‘Internal Production Control’ procedure may be followed, but with the additional requirement that the technical documentation is to be communicated to a Notified Body, which retains it:
and issues to the manufacturer what is variously called an ‘EU Technical File Receipt’ (Lloyd’s Register), or a ‘Certificate of Receipt of Technical Documentation’ (CML).
Any of these three types of Notified Body involvement in the conformity assessment process are to be recorded in the Declaration of Conformity for the product:
UK Notified Bodies
On 22 January 2018, the European Commission issued a notice to the effect that certificates issued by UK Notified Bodies will lose their validity immediately upon the UK’s withdrawal from the EU, in the absence of transitional arrangements:
It is doubtful whether the Notice is correct since, as I pointed out in my last article (and previously), EU law appears to be silent on whether existing certificates lose their validity in the event of the denotification of the NB that issued them. Indeed current Commission guidance states that, on the contrary, they will remain valid until positive demonstration is made that the certificates should be withdrawn.
That said, the Commission Notice carries weight whether correct or not, and could result in products certified by UK NBs being taken off the EU27 market. In the current state of affairs, therefore, it would seem foolhardy for manufacturers, wherever based, not to ensure that their products are certified by an EU27 Notified Body before 31 October this year.
I have shown in four successive posts that, of what were four UK medical device Notified Bodies, BSI and UL UK have already made provision to transfer their certificates to the EU27, SGS UK are expecting to be ready to do so in the third quarter of this year, and Lloyds Register have ceased their medical device operation, leaving their customers with the necessity to transfer their certificates to another NB whether there is a No Deal UK exit or not. There is little reason, therefore, to expect any interruption in the access of medical devices to the EU27 market in the event of No Deal.
It may be, however, that extra priority has been given to medical devices on account of the potential threat to human life and health caused by hindrances to their availability. My purpose in this post is to examine another field, and ascertain whether a similar state of affairs pertains there also. ‘Ex’ products were selected because they generally require certification, and because it might be expected that there would be significant numbers of UK manufacturers, owing to the specialised character of the field and the presence in the UK of substantial oil, chemical and process sectors, where potentially explosive atmospheres can occur.
Eight UK Notified Bodies are notified under the ATEX Directive:
Since the referendum, all have taken steps to establish an ATEX Notified Body operation in the EU27. At the time of writing, five have completed the process, with the following new ATEX Notified Body operations being established:
CML B.V. The Netherlands. May 2018.
ExVeritas ApS. Denmark. January 2019.
SGS Fimko. Finland. February 2019.
FM Approvals Europe Ltd. Ireland. February 2019.
Intertek Italia Spa. Italy. March 2019.
All the other 3 UK NBs have established ATEX operations in the Netherlands, and all 3 received accreditation for ATEX tasks by the Dutch Accreditation Council in January 2019:
Lloyd’s Register Verification B.V.
CSA Group Netherlands B.V. (Sira being now part of CSA Group).
Element Materials Technology Rotterdam B.V.
Lloyd’s Register report that, after their successful accreditation, the Dutch ministry initiated the notification process, but that objections were raised with the European Commission by another member state (unnamed by Lloyd’s), not only to Lloyd’s notifications but to those made on behalf of other companies also:
They report further that the Commission has imposed stricter requirements for new Notified Body appointments in the Netherlands, and that they are making adjustments to comply with these, a process which is expected to take six to eight weeks:
In my next post, I describe in a little more detail the establishment of CML’s ATEX Notified Body in the EU, and look for evidence of the transfer of certificates to the new operation.
- The hyphenation seems odd, and is omitted by some certifiers. ↩