If NB's (notified bodies) cannot be trusted how can we?

M

MIREGMGR

#31
Is it correct that there are three separate TUVs--TUV Nord, TUV Sud, TUV Rheinland--and the court case therefore does not involve the other two?
 
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S

SteveK

#33
The list is as follows.

Withdrawn Status
MDD
UK Intertek Testing & Certification Ltd. - a real surprise one.
FYI

This part of Intertek had a very limited scope wrt Medical Device certification, so not really a surprise. Their real arm for MD certification based in the UK is AMTAC Certification Services Ltd, who they acquired 10 years ago.

Steve
 

pkost

Trusted Information Resource
#34
Regardless of scope and that they have a seperate "real" notified body, intertek should have the systems and processes in place necesssary to fulfil their obligations as a notified body. If they do not have the systems and have no business interest in maintaining approval, they should notify the MHRA and wind down that aspect of the business.

Although AMTAC is a seperate business, they are part of the same group. What assurance can be given to demontrate that the practices that were permitted at Intertek are not present at AMTAC?
 
K

kanwal

#35
In view of the listing on the withdrawn/suspended page, it seems that major NBs are restructuring their operations to more centralised operations rather than decentralised operations that were the norm earlier.

Probably it is in this context that Intertek has opted for this course.

Please note this is only a conjecture, and nothing more considering the other information on NANDO.
 
M

MIREGMGR

#36
Despite the similarity in name, these are separate entities.
Yes, understood. My (implied) point was that if participants in this thread further discuss the French court case and the parties involved, it might be preferable to specify "TUV Rheinland", not just "TUV", as the latter name could result in unjustified confusion.
 

pkost

Trusted Information Resource
#37
For clarity, there are 6 TUV notified bodies....

NB 0408 T?V AUSTRIA SERVICES GMBH Austria
. NB 0044 T?V NORD CERT GmbH Germany
. NB 2274 TUV NORD Polska Sp. z o.o Poland
. NB 1008 T?V RHEINLAND INTERCERT KFT. Hungary
. NB 0197 T?V Rheinland LGA Products GmbH Germany
. NB 0123 T?V S?D Product Service GmbH Zertifizierstellen Germany
 
R

Reg Morrison

#39
An interesting piece concerning the legal ramifications for NB's, in the aftermath of this legal case is available at http://www.lexology.com/library/detail.aspx?g=bc1e3486-b133-4c69-9020-2a122935cc77:

European Commission Interim Measures

Partly in response to the PIP incident but prior to the French court?s ruling above, the European Commission introduced interim measures relating to the medical devices sector on 25 September 2013 (see Commission Implementing Regulation 920/2013, and non-binding Commission Recommendation 2013/473/EU).

The measures include a requirement on notified bodies to conduct unannounced inspections of manufacturers and to check samples, as well as rules on conflicts of interest. Importantly the measures require notified bodies to ensure that they are properly resourced, whether that involves the assistance of subcontractors or subsidiaries or not, and that their staff are fully qualified to carry out the assessments required. In particular there are restrictions on what may be subcontracted by notified bodies. The measures also require Member States and the Commission to take a more active role in the assessment, regular surveillance, monitoring and investigation of notified bodies.

What does this mean for industry?

If courts in other Member States adopt a similar approach, this decision signals that the potential liability exposure of notified bodies? cannot be confined to contractual risks alone. Nor can a notified body necessarily rely on the fact that a manufacturer has acted fraudulently as a defence as the court may consider the fraud to have been discoverable by an appropriately thorough inspection, as in this case.

The French court recognised a wide public duty on the part of notified bodies by reference to the MDD, which appears to be owed not only to end-user patients but also to distributors. If notified bodies fall short of this duty, then they may face significant damages claims from both distributors and patients. Given the scale of distribution of products such as the PIP breast implants, overall liability could be significant. Notified bodies will therefore likely need to review their insurance coverage. These costs will necessarily have to be passed on to industry and ultimately commissioners and consumers.

For manufacturers the increased potential liability exposure of notified bodies and the requirements imposed through the interim measures is likely to mean that applications for certification will have a longer turnaround and that reviews and audits will be more expensive as well as more challenging. Ultimately this may well mean that products will take longer to get to market and that costs will increase. If, as expected, there is a consolidation of notified bodies (i.e. fewer in total, with less capacity between them) industry may also experience a ?bottle-necking? of applications, particularly once the MDD revisions are effective requiring notified body-reviewed upgrades to existing, as well as new, product dossiers.
 
R

Reg Morrison

#40
An update: http://www.lexology.com/library/detail.aspx?g=28a21496-a3d9-4b05-8a13-fa3027f826c8

While the French court ruled against the Notified Body, courts in Germany, where numerous cases are pending, have, until now, (also in appeal) consistently ruled in favor of TUV Rheinland.

Although the facts presented are almost identical, German courts have generally accepted that TUV Rheinland diligently performed its duties and did not have the means and powers to uncover the fraudulent acts of PIP.

German and French courts have thus reached seemingly contradictory conclusions about the scope of the obligations and powers of the Notified Bodies under the MDD. This difference in approach by EU courts leads to increased forum shopping by patients, who now are looking to initiate claims in France.

It is interesting to note that the Regulation Brussels Ibis (Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (O.J. 20.12.2012, L 351/1)) which will be applicable to the enforcement of judgments rendered in judicial proceedings instituted after 10 January 2015, has drastically simplified the enforcement in one Member State of court decisions rendered in another Member State. While the Brussels Ibis Regulation is not applicable to the decision of the French Court of commerce, it may very well be applicable to the future proceedings which will be initiated in 2015 in the aftermath of this decision.
 
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