The transfer of UL UK’s medical device EC Certificates to Poland

In my penultimate post, I discussed the closure of Lloyd Register’s medical devices Notified Body operation, announced on 13 June 2019. Less than three weeks later, on 1 July, the UK subsidiary of Underwriters Laboratories, announced that it too was closing its medical devices Notified Body operation, with effect from 1 September 2019:

Whereas Lloyd Register has ceased its medical device Notified Body work altogether, however, UL had entered into a ‘partnership’ with the Polish Notified Body PCBC (Polskie Centrum Badan I Certyfikacji):

to which 80% of certificates had been transferred, with the remainder having gone to another unspecified EU27 Notified Body:

The closure of the UK operation is not absolute, however, since UK UL will retain its capacity to certify just one type of device, under the In Vitro Diagnostic Medical Devices Directive (98/79/EC):

A comparison of the scope of UL UK’s notification under the IVD with that of PCBC shows that it is this type of device, to assess the risk of trisomy 21 (otherwise known as Down’s Syndrome) that is uniquely absent from the latter. UL UK’s scope includes IVD 308:

whereas that of PCBC does not:

It therefore makes sense for UL UK to maintain its notification for this type of device for so long as it is able to. It may be that PCBC is applying to the Polish notifying authority to extend its scope to include ‘Risk of trisomy 21’, possibly in connection with the partnership with UL, but this is not stated.

I have been able to trace the transfer of certificates from UL UK to PCBC in three cases, two under the MDD, and one under the IVD. I conducted a search for UL UK EC Certificates under the MDD a few weeks ago, and recorded the web links along with a screen shot. In two cases, the link that used to point to a UL UK certificate now points to a PCBC certificate. Thus the link that used to point to a UL UK Full Quality Assurance System certificate for Electromedical Products Inc of Texas, USA:

now points to the same type of certificate, with the same expiry date in 2023 but issued by PCBC on 29 April this year:

Likewise, a Full Quality Assurance System certificate issued by UL UK in 2018, with expiry in 20123, for Neurotec in Brazil:

used to reside on a URL where a PCBC certificate, of same type and expiry date, but issued on 26 April this year, now dwells:

UL UK, MDD

A search for EC Certificates issued by UL UK under the MDD:

EC + Certificate + Notified + Body + 0843 + 93/42/EEC

yields thirteen results, including 5 certificates issued to manufacturers in the USA, two each for Brazil and India, one for Germany, Spain, Netherlands and Taiwan, with the expiry date shown:

IDx, LLC, USA. April 2019.

American Orthodontics, USA. April 2018.

Respiratory Technology, USA. December 2022.

DMC, Brazil. May 2023.

Simex, Germany. January 2022.

Biodinâmica, Brazil. May 2022.

Leventon, Spain. June 2022.

Cogentix, USA. August 2019.

Rolence, Taiwan. March 2021.

Modern Orthodontics, India. March 2022.

Skanray, India. November 2019.

Expired

Diasoft, Netherlands. April 2019.

A-dec, USA. October 2016.

(That none were for manufacturers in the UK, while three were for EU27 manufacturers, provides a nice illustration of the reality that the Commission’s current policy of holding existing UK NB certificates to be invalid upon the UK’s departure from the EU, has the potential to impede the EU27’s imports of products from all over the world, including the EU27 itself, not only from the UK.)

PCBC, MDD

A search for EC Certificates issued by PCBC under the MDD:

EC + Certificate + Notified + Body + 1434 + 93/42/EEC

yielded no other newly issued certificates than the two shown above:

Przedsiębiorstwo, Poland. July 2017 – July 2023.

Electromedical, USA. 29 April 2019 – 12 September 2023.

Neurotec, Brazil. 26 April 2019 – 1 December 2023.

Expired

Zaklad, Poland. June 2012 – August 2015.

Cardionovum, Poland. December 2013 – December 2018.

Lutonix, United States. December 2013 – March 2018.

EuroImplant, Poland. September 2010 – September 2015.

PCBC, IVD

I conducted an additional search for EC Certificates issued by PCBC under the IVD:

EC + Certificate + Notified + Body + 1434 + 98/79/EC

and found two certificates, the first not the result of a transfer:

TürkLab, Turkey. August 2016 – August 2019.

and the second a Full Quality Assurance Certificate, issued on 8 May 2019 to a Danish subsidiary of Agilent (headquartered in the USA), which must be the result of a transfer from UL UK:

Dako, Denmark. 8 May 2019 – July 2023.

since the same type of certificate was issued by UL UK to the same company under the same Directive in 2014 (see below).

UL UK, IVD

A search for EC Certificates issued by UL UK under the IVD:

EC + Certificate + Notified + Body + 0843 + 98/79/EC

yielded the following results:

NHS Blood & Transplant, UK. March 2023.

Rapid Labs, UK. May 2023.

ProBioQual, France. November 2020.

Omega, UK. August 2019.

Benetech, Canada. August 2023.

Cellabs, Australia. August 2019.

Expired

NIBSC, UK. February 2019.

Lab21, UK. January 2019.

Lorne Laboratories, UK. May 2018.

Biokit, Spain. March 2014.

Dako, Denmark. August 2015.

Of the six in-date certificates issued by UL UK under the IVD, three were issued to manufacturers in the UK, and one each for France, Canada and Australia.

That UL UK states that it has transferred all its certificates to the EU27, and 80% of them to PCBC, while at the same time there appear to be many more UL UK certificates still available online than PCBC certificates, may be explained either by normal inertia, or perhaps by a perception that UL has a higher standing – whether deserved or not – with potential customers than PCBC. Even if manufacturers are choosing for the time being to keep their outdated UL UK certificates online, conceivably bemoaning the fact that their products are now carrying a certificate bearing a less instantly recognisable name, such considerations must weigh less heavily than the assurance they may now be presumed to have of continuity of access to the EU27 market in the event that the UK leaves the EU without a Withdrawal Agreement on 31 October 2019.

This is the first instance I personally have seen of a UK Notified Body providing continuity through a partnership with an existing EU27 NB rather than through establishing or expanding its own operation in the EU27.

Andrew Chapman

 

 

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