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In Vitro Diagnostics
In Vitro Diagnostics
IVDs have distinct requirements in both the US and Europe. We have the IVD regulatory, quality system and clinical study expertise needed for US and European market entry.
Helping companies understand the important differences between US and European requirements for drug-device combination products and drug delivery devices.
CJEU asked to clarify device liability of Notified Bodies
21 April 2015
A German court has referred a liability case concerning the PIP breast implant fraud to the Court of Justice of the European Union (CJEU), seeking clarity on the responsibilities for medical devices in the European Union (EU), in particular the responsibility of Notified Bodies (NBs). The CJEU’s answer may have a major impact on how NBs work and charge for their services to medical device manufacturers in the future.
The German plaintiff in this case had sued the NB, TÜV Rheinland, for damages when PIP ceased business after the implant scandal. In her claim, the plaintiff alleged that TÜV Rheinland did not comply with its obligations under the Medical Devices Directive 93/42/EEC. It was also alleged that had PIP's records been properly reviewed by the NB, PIP's misconduct would have been identified and the implants prevented from being placed on the market.
The German Federal Court of Justice (BGH) has asked the CJEU to address the question of whether the work of a Notified Body is supposed to have a protective effect towards patients, such that patients are entitled to claim damages directly from the NB in the case of defective devices. Specifically, the BGH has requested clarity on the following questions:
Is it the objective and intention of the Medical Devices Directive 93/42/EEC that in case of Class III medical devices, Notified Bodies are also acting with the purpose of protecting potential patients so that the Notified Body can be liable towards patients when they negligently violate their obligations?
Does Annex II of Directive 93/42/EEC require that that in case of Class III medical devices, Notified Bodies also have the – general or for-cause – obligation to test the respective product?
Does Annex II of Directive 93/42/EEC require that in case of Class III medical devices, Notified Bodies also have the – general or for-cause – obligation to review the business records of the device manufacturer and/or carry out unannounced audits?
Lower German courts had dismissed the case against the NB, holding that the legal purpose of the NB’s activities was not to protect potential patients. In contrast to the German decision, similar plaintiffs have been successful in the French courts in obtaining verdicts against TÜV Rheinland.
The decision of the CJEU should provide clarity on the scope of responsibilities of Notified Bodies, so that different decisions in different EU Member States on the same issue can be avoided.
This latest involvement of the CJEU comes quickly after a decision of 5 March 2015, in which the court substantially increased the product liability risks for medical device manufacturers, deciding that, in this specific case, manufacturers of implantable devices recalled because of risks that the items were defective should also pay for any costs associated with explantation and replacement.
FDA Issues Draft Guidance on Combination Product Manufacturing
12 February 2015
Two years after issuing a final rule on current good manufacturing practice (cGMP) requirements for combination products, the US Food and Drug Administration (FDA) has announced the availability of draft guidance that explains the final rule and further clarifies how manufacturers should comply with cGMP requirements. Following publication of the final rule, there were requests for additional guidance on implementation, and FDA has reacted by issuing this draft.
The draft guidance reviews the definition of a combination product and reiterates that the final rule on cGMP requirements applies to all combination products. Accordingly, the final rule applies equally to:
A 'single entity' combination product, meaning a product comprised of two or more regulated components, that are physically, chemically, or otherwise combined or mixed and produced as a single entity (e.g., a prefilled syringe);
A 'co-packaged' combination product, meaning two or more separate products that are packaged together as a unit and comprise drug and device, device and biological, or biological and drug products (e.g., a surgical kit); and
A 'cross-labeled' combination product, meaning a drug, device, or biological product that is intended for use only with another separate drug, device, or biological product, where both are required to achieve the intended use, indication, or effect (e.g., a light-emitting device and a light-activated drug).
The draft guidance further clarifies the definitions of some of the key terms in the final rule, such as the distinction between drug containers and closures as compared to delivery devices, and usefully provides examples and hypothetical scenarios to further clarify how manufacturers can comply with the cGMP regulations in the final rule, addressing which cGMP responsibilities apply to specific manufacturers and illustrating steps sponsors can take to coordinate cGMP compliance across facilities.
Concurrent with the publication of this draft, FDA has withdrawn the September 2004 draft guidance entitled 'Current Good Manufacturing Practice for Combination Products'. Comments regarding the newly-issued draft guidance are due by 30 March 2015.