I am continuing my series on medical devices currently certified for the EEA market by Notified Bodies established in the UK. For the sake of simplicity, I am confining myself to products covered by the Medical Devices Directive (MDD) rather than the IVDD (In Vitro Diagnostic Medical Devices Directive) or the AIMDD (Active Implantable Medical Devices Directive). The European Commission announced in January 2018 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.
As I discussed in my last post, Lloyds Register closed their medical devices notified body operation last month, leaving their clients little time to transfer their certification to another NB. BSI appear to have the matter well in hand, having established an operation in the Netherlands at the end of last year and having urged their clients early this year to take advantage of the opportunity to transfer their certification to that new NB. In this post, I examine the situation with SGS UK, SGS being reportedly the world’s largest testing, inspection and certifying company, headquartered in Switzerland.
Among medical devices registered in the Netherlands, 43 were certified by SGS UK under the MDD in November 2018:
compared to 404 by BSI and 64 by Lloyds Register.
As I described in an earlier post (Section: ‘SGS UK’), SGS already had two subsidiaries in the EU-27, namely in Belgium and in Finland, that were notified for medical devices. Unlike SGS UK, however, neither were notified for the IVDD. Moreover, neither had as extensive a scope under the MDD as the UK subsidiary, with Class III products excluded, among other relative deficiencies.
SGS UK’s current advice is that most clients with Class I and II devices can transfer their certification to Belgium or Finland. At the same time, the scope of SGS Belgium is being extended to include Class III devices, with completion of the process being expected during the third quarter of 2019:
It seemed to me, then, that a search for medical devices certified by SGS Belgium (NB no. 1639) and SGS Fimko (NB no. 0598) should produce some certificates bearing evidence of a recent transfer from SGS UK. However, neither did so, with the search for the Belgian certificates:
EC + Certificate + Notified + Body + 1639 + 93/42/EEC
yielding the following results:
Wae Newco, Belgium. August 2020.
MedEnvision, Belgium. October 2020.
F Care Systems, Belgium. March 2020.
Hubert De Backer, Belgium. July 2022.
R. Borghgraef, Belgium. March 2021.
Surgi-Tec, Belgium. October 2023.
ERPA Instruments, The Netherlands. May 2020.
Fysiomed, Belgium. February 2022.
Lucimed, Belgium. March 2020.
(Pharmacar, Belgium. February 2015.)
Apart from the lack of indication of transfer, nine and out of ten of the certificates are held by Belgian companies, and one by a Dutch company. If certificates had been transferred from SGS UK, it is quite unlikely that they would have been held by Belgian or Dutch companies, of which there is only one example in the list of SGS UK certificate holders below.
A search for EC Certificates issued by SGS Fimko under the MDD:
EC + Certificate + Notified + Body + 0598 + 93/42/EEC
gave the following results:
Spiromagic, Denmark. April 2023.
(Aerotel, Israel. March 2019.)
Thermidas, Finland. August 2023.
Foshan Shunde, China. April 2021.
Foshan Cingol, China. November 2021.
NuvoAir, Sweden. September 2020.
Apart from the paucity of results, three of the six certificates are held by manufacturers in Nordic countries, who might be more likely to have chosen a Finnish NB in the first place. None of the certificates show any sign of a transfer from SGS UK.
In contrast, a search for EC Certificates issued by SGS UK under the MDD:
EC + Certificate + Notified + Body + 0120 + 93/42/EEC
yielded many certificates held by UK manufacturers, among others:
Enteral, UK. January 2021.
Aalba Dent, USA. March 2021.
Kabomed, Egypt. December 2020.
Alesi, UK. January 2022.
Pelican, UK. May 2022.
Rocialle, UK. February 2023.
Moor Instruments, UK. December 2023.
Haag Streit, UK. February 2021.
Vertex-Dental, Netherlands. December 2020.
GBUK, UK. January 2021.
Stoddard, UK. February 2021.
Owen Mumford, UK. March 2021.
Henkel, USA. February 2021.
Network Medical, UK. May 2023.
Andersen Caledonia, UK. January 2023.
Altomed, UK. October 2023.
Hu-Friedy, USA. July 2020.
Kenda, Liechtenstein. November 2022.
LiDCO, UK. May 2022.`
Ultravision, UK. July 2020.
Apeiron, Spain. February 2020.
Medfor, UK. December 2023.
Medicontur, Hungary. May 2022.
Sterimedix, UK. February 2020.
Vanetti, Switzerland. July 2023.
Berendsen, UK. 11 July 2019.
Brymill Cyrogenics, USA. February 2020.
Mark’Ennovy, UK. July 2021.
Unimed, Switzerland. December 2023.
Shofu, Japan. March 2020.
Finesse, Ireland. July 2022.
LaproSurge, UK. November 2021.
MicroBase, Taiwan. October 2019.
Purple Surgical, UK. May 2020.
Digitimer, UK. October 2022.
Dentsply, Belgium. February, 2019.
S Murray, UK. July 2018.
Juvora, UK. October 2017.
Of 38 manufacturers holding EC Certificates issued by SGS UK, found in this search, 23 or just over 60% are in the UK, 4 in the USA, 2 in Switzerland, and one each in Egypt, Spain, the Netherlands, Taiwan, Ireland, Belgium, Liechtenstein, Hungary, Ireland and Japan. A total of 5 are in the EU27.
Did SGS advise their clients to migrate their certificates?
As described in an earlier post, BSI issued an urgent notice on 29 January 2019 urging its customers to migrate their certificates to their new Dutch Notified Body. A search yielded many certificates issued under the MDD by this new NB.
In contrast, SGS UK only pointed out to their customers that it would be possible ‘in most cases’ to transfer certificates to the EU27. More information was available on request:
I have not found any evidence of any such transfers having taken place. From the lack of movement, it seems likely that SGS UK’s direct communications with its customers had a similar tone to that adopted on the web-site. They could transfer if they chose to, where this was possible; but they were was no positive advice to do so.
If this is correct, then why did SGS UK not issue a warning, and allow their customers to run the risk of being left without a certificate in the event of a No Deal Brexit on 31 March 2019? I can see four possible explanations, which are not exclusive:
i) They thought the probability of No Deal was very low.
ii) They preferred to carry out the transfer in one single operation, once they had achieved full scope in Belgium. Apart from administrative simplicity, they might have been concerned about the effect on those customers who were not able to transfer at that time, and who might have felt abandoned by SGS and inclined to look for an alternative EU27 Notified Body.
iii) To the extent that a transfer of certificates involves also a transfer of staff, they wanted to avoid a dislocation that might turn out to be unnecessary.
iv) They thought that in the event of No Deal, the Commission would not in fact carry out its policy of making existing certificates invalid. Conceivably, they could have been advised by the Commission privately to this effect.
In an earlier Brexit update, SGS UK had expressed confidence that the EU would not actually carry out their threat. They acknowledged the current ‘extreme’ position being taken by the Commission, but believed that they would be forced to a more ‘pragmatic’ position:
They also made reference to the existing procedures for ‘orphaned products’ (which I described here), and presumed they would be put into effect in the event of No Deal, if no other arrangements for temporary continuity had been put into place:
Hopefully, SGS UK will receive their medical device notified status in the Netherlands in time to transfer certificates there before a possible No Deal exit on 31 October 2019.
withdrawal of a notification does not affect certificates issued by the notified body up to that point, until such time as demonstration can be made that the certificates should be withdrawn.