On 13 June 2019, Lloyd’s Register announced that it would no longer be providing medical device Notified Body services:
citing unspecified ‘recent market developments’. As well as closing its UK medical device Notified Body operation, it was also withdrawing its application for medical device notified status in the Netherlands:
As it happens, I heard the news yesterday from medical device manufacturers holding Lloyds Register EC Certificates who I had contacted to enquire about their No Deal Brexit preparations. Their current certificates will now expire on 30 September 2019. But one told me that in such a case where a certificate is soon to expire, the transfer to a new Notified Body takes 6-9 months. They therefore appeared to be faced with a loss of access to the EU27 market.
In my letters of enquiry, however, I had made mention of the ‘grace period’ arrangements instituted by France and the Netherlands to enable continued market access in exactly this kind of circumstance, where a Notified Body ceases operation for one reason or another. I explained in my article on the subject that the French competent authority ANSM is willing to grant an extension of up to a year on the validity of a certificate, while it is being transferred to another Notified Body, provided certain safeguards are in place. What is more, a decision by ANSM provides access to the entire EU, not to France only.
I am not aware of any reason why this should not be a viable option for manufacturers who are unable to transfer to an EU27 Notified Body by 30 September. If it is, at the least, an option worth pursuing, it seems remiss of Lloyds Register and the MHRA not to bring it to the attention of manufacturers faced with a loss of access to the EU market, including even the UK market.
As for the reason for the sudden cessation of operations, one possible explanation is as follows. Llloyds Register were informed (section on ‘Lloyds Register’) some time after an assessment by the Dutch competent authority in March 2019 that they would not achieve notified status before 2020. Once this was made known some manufacturers would likely have taken steps to transfer to an EU27 body. The downfall of Mrs May, and her probable succession by a Prime Minister more willing to countenance a No Deal exit on 31 October 2019, may have set in motion an accelerated departure of manufacturers from Lloyds Register. This is perhaps what they are referring to as ‘recent market developments’.
Relation to No Deal
As things stand, all manufacturers who currently hold a Lloyds Register EC medical devices certificate, and who want to maintain access to the EU market after 30 September 2019, will have to apply to another Notified Body. It would make no sense to apply to a UK NB, since having retained access on 1 October they might then lose it on 1 November in the event of No Deal.
So it is reasonable to assume that all such manufacturers will now apply to an EU27 NB. If they are able to transfer before 30 September 2019 then no difficulty arises. If not, then it is possible that they will be able to apply for a grace period to France or the Netherlands, and thus gain access to the whole EU market. While the proximate cause of the Lloyds Register closure may be Brexit, the immediate cause is a change in the market for their service. There is no apparent reason why it should not be treated as any other NB closure, and so that manufacturers would be eligible for a grace period, while they complete their transfer to a new NB.
From 1 October, a manufacturer will either:
i) have a new certificate from an EU27 body; or
ii) be under ‘grace period’ arrangements while they transfer to an EU27 body; or
iii) have no certificate or arrangement and be unable to sell their product in the EU27 market (and presumably not in the UK market either).
A No Deal exit on 31 October 2019 would not have any impact under any of these evantualities, since it would only affect those holding certificates issued by UK NBs. No manufacturer will be holding a Lloyds Register medical device EC certificate by that time.
High proportion of expired certificates
A Google search for EC + Certificate + Notified + Body + 0088 + 93/42/EEC yielded the results that follow below, 0088 being the Notified Body number of Lloyds Register Quality Assurance Ltd. In a remarkably large proportion of cases, the certificate was out of date, and a specific search for a more recent certificate yielded no result. I have listed expired and in date certificates separately to demonstrate the point.
Some hint as to the reason for this phenomenon comes from two emails received from an EU27 manufacturer, received in response to my enquiry and follow-up as to why they were holding on their web-site a certificate that had expired (in 23 December 2018). They replied that they had now received a new certificate, but only after a delay of 4 months in which they were unable to contact Lloyds Register and during which they were unable to sell their products in the EU:
Possibly there was a capacity problem at Lloyds Register at this time, the first few months of 2019. Perhaps, to speculate, they had lost key staff to other companies, finding them difficult to replace in such a specialised field.
Of a total of 33 Lloyds Register MDD EC Certificates, 19 are expired and 14 in date.
Sixteen, that is just under half, of the manufacturers are based in the UK. Three are in Denmark and in the USA, two in the Czech Republic, and one each in France, Germany, Belgium, Estonia, Sweden, Netherlands, Switzerland, Jordan and the Channel Islands.
BOC, UK. 29 May 2019.
Osteotec, UK. October 2018.
Vicon, UK. August 2018.
Purite (now part of Suez), UK. May 2018.
Medaes, UK. August 2011.
Female Health Company, UK. November 2017.
Sterima, Belgium. January 2019.
TT Meditrade, Denmark. March 2019.
Innoventa, Denmark. December 2018.
Cook, USA. April 2019.
TCM Associates, UK. February 2019.
LPG Systems, France. September 2018
Forza, UK. 7 June 2019.
Chemi-Pharm, Estonia. April 2019.
Huntleigh, UK. April 2019.
Efada, Jordan. May 2019.
Medical Technology, Channel Islands. April 2018.
Safina, Czech Republic. January 2018.
Pall Medical, Switzerland. 7 July 2019.
Heeley Surgical, UK. May 2020.
Planer, UK. July 2020.
Medical Wire, UK. 30 June 2019.
Primadental, UK. September 2020.
Puretone, UK. 31 January 2021.
Dentalmind, Sweden. February 2021.
Keeler, UK. 31 October 2019.
Vestfrost, Denmark. 26 July 2019.
Cantel, UK. January 2022.
Atrion, USA. 6 August 2019.
Bioline, Czech Republic. 14 October 2019.
Scholten, USA. December 2020.
Atlas Copco, Netherlands. 1 August 2019.
Information on ‘grace period’ arrangements
For the benefit of any manufacturers struggling to meet the 30 September deadline, my article on ‘grace period’ arrangements first describes their origin in a meeting of CAMD (Competent Authorities for Medical Devices) in October 2016, which agreed guidelines for the management of situations created by NB denotifications. It then describes the background in the PIP scandal, the resulting inspections of Notified Bodies and voluntary and involuntary cessation of Notified Body operations, resulting in many orphaned products. Finally, it outlines the implementation of the guidelines by the French and Dutch competent authorities, opening the possibility of continued market access for manufacturers with expired Lloyds Register medical device EC Certificates.