In my last three posts I have been examining the barriers to trade that could arise in the event of No Deal as a result of the UK Notifed Bodies’ loss of notified status. 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. In part 3a, taking medical devices as an example, I looked at the efforts made by UK Notified Bodies to gain the required notifications in branches situated in EU-27 member states, so that existing certificates can be transferred across, and new certificates issued. I concluded that BSI, the largest of the four main UK medical device NBs, has probably largely completed this process. Lloyds Register and SGS UK have the process underway but not yet completed. I found no definite indication that Underwriters Laboratories are attempting to achieve notified status for medical devices in the EU-27. While some manufacturers may have taken action to migrate their certificates to other companies or organisations with notified status in the EU-27, the impression I have gained is that many have preferred to remain with their current notified body. If this is correct, then products certified by Lloyds Register, SGS UK and UL UK would, as things stand, lose access to the EU internal market immediately in the event of No Deal.
In part 3b, I drew attention to longstanding Commission guidance that certificates previously issued by a notified body would not immediately lose their validity if the body ceased operation; and in 3c, I detailed more specific guidance currently in operation to allow a grace period of up to a year in the medical device sector for ‘orphaned’ certificates of this sort. Arguably, therefore, the Commission’s decision with regard to Brexit is in contradiction to its own guidance, and to current practice in the EU.
Nevertheless, the decision has been taken, making it necessary to try to assess the consequences of it being put into effect in the event of No Deal. I will show in this and subsequent posts that a remarkably high proportion of medical device manufacturers worldwide, including within the EU-27, have employed UK NBs to certify their products.
The UK has decided that in the event of No Deal, these products which had been certified by UK NBs would continue to be accepted onto the UK market. The impact on patients and the medical services would therefore appear to be limited more or less entirely to the EU-27. The impact on manufacturers, while probably concentrated to some degree in the UK, would be felt worldwide. Pressure on the EU to allow a grace period could be expected to come from many exporting countries as well as from users of medical devices in the EU-27 countries. There would seem therefore to be some grounds for hope that, in the event of No Deal, the EU would revert to its normal policy on orphaned products, and allow them continued access to the internal market, while they were being migrated under supervision to EU-27 NBs.
Migration of BSI Certificates
As I described in an earlier post, BSI achieved medical device Notified Body status in the Netherlands in November 2018. On 29 January 2019 it issued a notice urging its customers to migrate their certificates to their Dutch subsidiary. Two questions present themselves. First, did manufacturers respond to BSI’s appeal and apply to migrate their certificates? Second, if they did so, has the process now been completed?
In order to gain some impression of the extent to which the migration process has in fact taken place, I conducted two online searches, one for certificates issued by BSI’s newly notified Netherlands, and one for BSI UK certificates.
BSI Netherland certificates
A search conducted on Google on 20 May 2019 for certificates issued by BSI Netherlands (NB number 2797) under the Medical Devices Directive:
EC + Certificate + Notified + Body + 2797 + 93/42/EEC
yielded 58 results, including, to take on example:
an Annex V Production Quality Assurance EC Certificate for the manufacture of corneal endothelium delivery instruments by CorneaGen Inc, USA:
issued on 20 February 2019:
The Certificate History describes it as traceable to NB 0086, that is, to BSI UK:
The full list of manufacturers, with location, and date of certificate issue, is as follows. It is in search order, except that all the certificates issued to one manufacturer are listed together.
HeraMED, Israel. 15 February 2019.
Therapy Equipment, UK. 8 March 2019.
ArjoHuntley, Sweden. 27 February 2019.
Argon Medical, USA. 19 February 2019.
Micrima, UK. 21 February 2019.
CorneaGen, USA. 20 February 2019.
Circle Cardiovascular, Canada. 11 February 2019.
Musculoskeletal Transplant, USA. 4 February 2019.
GC Tech. Europe, Germany. 14 February 2019.
ASO LLC, USA. 28 February 2019.
Medical Components, USA. 26 February 2019.
Accuvein, USA. 8 March 2019.
Össur, Iceland. 14 February 2019.
US DEFIB, USA. 26 February 2019.
Jacoti, Belgium. 10 January 2019.
Aspen Surgical, USA. 3 January 2019.
Vital Images, USA. 21 February 2019.
Ranfac, USA. 7 February 2019.
DTR Medical, UK. 28 February 2019.
Geuder, Germany. 14 January 2019.
Synergy Health, UK. 11 March 2019.
JTECH, USA. 20 February 2019.
Medica Europe, Netherlands. 8 February 2019.
Henke-Sass, Germany. 8 January 2019.
Teledyne, USA. 25 March 2019.
Neotech, USA. 4 February 2019.
Sanlilar, Turkey. 8 May 2019.
Fuji Systems, Japan. 26 February 2019.
Ilermiplant, Spain. 7 February 2019.
First Water, UK. 1 May 2019.
Strata Medical, USA. 21 March 2019.
Peek Health, Spain. 27 February 2019.
Southmedic, Canada. 26 February 2019.
Sanatmetal, Hungary. 13 February 2019.
ClaroNav, Canada. 28 February 2019.
Nox Medical, Iceland. 14 February 2019.
AO NPF ‘BIOSS’, Russia. 25 February 2019.
Intelerad, Canada. 25 January 2019.
NSK Europe, Germany. 19 February 2019.
LKC Technologies, USA. 8 March 2019.
ZL Microdent, Germany. 14 February 2019.
CMP Industries, USA. 19 February 2019.
Emery Enterprises, USA. 4 March 2019.
Euromi, Belgium. 27 February 2019.
Argen, USA. 12 February 2019.
Nuraleve, Canada. 18 March 2019.
Paxman, UK. 11 March 2019.
Ryazan State, Russia. 7 February 2019.
Augustine, USA. 21 March 2019.
Catheter Research, USA. 7 March 2019.
MTN Neubrandenburg, Germany. 26 February 2019.
Merit Medical, USA. 8 February 2019.
Mayfair, France. 22 March 2019.
The majority of certificates were issued in February, with only two being issued later than March:
One would expect many applications to have been made soon after the BSI’s notice of 29 January. If the migration process were a long one, resulting in a backlog of applications, then one would I think expect to find certificates issued in April, and more than two in May. It seems probable then that the migration process has been conducted quickly, with the May issues perhaps reflecting late applications.
22 of the 55 manufacturers were located in the United States, with 7 in the UK, 6 in Germany, 5 in Canada, two in Iceland, Belgium, Spain and Russia, and one in Israel, Sweden, France, the Netherlands, Hungary, Japan, Turkey and Taiwan.
Devices currently certified by BSI UK
Google searches conducted in May 2019 for certificates issued by BSI UK (NB number 0086) under the MDD:
EC + Certificate + Notified + Body + 0086 + 93/42/EEC
revealed that many companies are still holding on their web-sites EC certificates issued by BSI UK. I examined the first 70 of these, listed below in search order. In some cases, which I indicate, a recently issued replacement certificate from BSI Netherlands is also to be found on the manufacturer’s web-site. In the other cases, I wrote to the company to ask whether they had followed BSI’s advice to migrate their EC Certificate to BSI Netherlands and, if they had, whether the process had been completed and they had received the new certifcate. Of eight companies that replied, all said that they now had a BSI Netherlands certificate. Two sent it by attachment; in three cases, I have taken the manufacturer’s word that they have their new certificate; in the other cases, the new certificate was found online.
Vitalograph, Ireland. July 2020.
Elekta, USA. October 2019.
Fujifilm, USA. June 2019. (UPDATE, 24 May 2019: advised by email that the company has transferred its Notified Body to BSI Netherlands)
iCAD, USA. July 2019.
Varian, USA. January 2020.
CooperSurgical, USA. August 2022.
Nipro, Spain. June 2023.
Minimus, USA. July 2019.
Adelphi Tubes, UK. May 2021.
Orthogem, UK. April 2012. (UPDATE, 24 May 2019: Advised by Orthogen that they have migrated to BSI Netherlands.)
Clear Guide, USA. April 2020.
Medical Indicators, USA. February 2023.
Varex Imaging, USA. January 2020.
Phagenesis, UK. July 2022.
Riverside Medical Packaging, UK. May 2023.
Vision RT, UK. June 2020.
Beeswift, UK. October 2021.
Viamed, UK. August 2021.
i-Dental, Lithuania. 15 June 2019. (Company advised by email that they have completed migration process and received their BSI Netherlands certificate.)
Rhythmia, USA. December 2017.
Organ Assist, Netherlands. November 2021.
mtfbiologics, USA. March 2021.
Sedana Medical, Ireland. April 2020.
GC Europe, Belgium. 6 May 2019.
LTE Scientific, UK. January 2024.
Deleo, France. August 2016.
MSS Medical, UK. April 2019.
Katena, USA. December 2022.
Elos Medtech, Denmark. November 2011.
HerART Aps, Sweden. August 2021.
Puritan Medical, USA. September 2023.
neoligaments, UK. January 2019.
CLB Group, Netherlands. October 2019.
BioVision, USA. February 2021.
DIR, Germany. April 2018.
Maillefer (p. 3 ff), Switzerland. August 2018.
Pioneer, USA. 18 June 2019.
Benmor, UK. February 2024.
Michelson, UK. July 2019.
AST Products, USA. September 2020.
Sofic, France. April 2020.
Cleveland, USA. October 2019.
BNOS Meditech, UK. October 2023. (Advised by a Director of the company by phone that migration to BSI Netherlands has been completed.)
CPI, Canada. March 2023.
BioVision, USA. February 2021.
Teleflex, Ireland. September 2020.
Intra-Lock, USA. July 2022.
Nagor, UK. April 2019.
Vitreq, UK. February 2021. Vitreq appears to have transferred its certification to the German Notified Body DQS, with the new EC Certificate taking effect from 29 March 2019, the day that the UK had been expected to leave the EU:
Dentsply, UK. September 2019.
Bayer, USA. March 2020.
Bio-Med Devices, USA. February 2022.
Of the seventy certificates, at least 18 have been replaced by a BSI Netherlands certificate, and one by a certificate issued by the German Notified Body DQS. One Director of a UK company said that he was in touch with many other medical device companies certified by BSI and that these had all, or almost all, applied to migrate their certificate(s) to BSI Netherlands.
Nevertheless, it remains difficult to interpret the data. Can the 8 manufacturers who replied to say that they now had a BSI Netherlands certificate be taken as representative of the whole? It seems to me that an unprepared company is less likely to reply than a prepared one. But it would surely be going to far to see a lack of reply as definite evidence of unpreparedness.
It would surely be in the interests of every manufacturer to respond to the urgent notice issued by BSI Medical on 29 January 2019, and migrate their certificate to BSI Netherlands in order to be able to continue to export their products to the EU in the event of No Deal. That so many BSI UK certificates are still online may be a reflection of normal inertia, or perhaps of a deliberate decision to display the old certificate until the product labelling has been changed.
That said, it remains the case that there are at least 51 manufacturers with an EC Certificate online that is certified by BSI UK, with no evidence found so far that it has been replaced by one certified by an EU 27 Notified Body. 21 of these manufacturers are located in the USA, 15 in the UK, 3 in Ireland, 2 in France and the Netherlands, and one each in Spain, Germany, Denmark, Sweden, Belgium, Switzerland, South Africa and Canada. A total of 12 are in the EU 27. If, for sake of argument, none of these manufacturers had a certificate issued by an EU27 Notified Body on the day of a UK No Deal exit, and the EU were to carry out its stated intention of rendering the BSI UK certificates invalid, then the impact on manufacturers would be nearly as great in the EU27 as in the UK. If the USA were to retaliate in kind then there could be a further impact on EU manufacturers. At the same time, the impact on patients and the health service would presumably be felt entirely in the EU27 and not in the UK, which has undertaken to continue to accept CE marked products. Would this be a rational approach for the EU to take?
24 May 2019. Fujifilm SonoSite Inc have advised that they have transferred their Notified Body from BSI UK to BSI Netherlands.
24 May 2019. BSI Netherlands EC Certificate, issued 18 February 2019, received from Sheffmed Ltd by email.
24 May 2019. Advised by Orthogen that they have migrated to BSI Netherlands.
24 May 2019. BSI Netherlands EC Certificate, issued 18 February 2019, received from eMoyo by email.