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Medical technology news: Testing daily practice

Medical technology news: Testing daily practice
Medical technology news: Testing daily practice

Unannounced audits in medical technology  
On 24 September 2013, the Official Journal of the European Union published a «Recommendation on the audits and  assessments performed by notified bodies in the field of medical devices». The significance of this recommendation  and how it is integrated in the current legislation is still a frequent topic of debate. However, the notified bodies are  in fact under very strong political pressure and will focus more intensively on daily practice via unannounced audits.


The legal situation
In addition to the recommendation regarding the audits and assessments undertaken by the notified bodies, the situation was also changed by the EU Commission’s implementing regulation no. 920 / 2013 «on the designation and the supervision of notified bodies in accordance with the Council directive 90 / 385 / EEC on active implantable medical devices and the Council directive 93 / 42 / EEC concerning medical devices». The recommendation in conjunction with the implementing regulation has a direct influence on manufacturers of medical devices.

First, the issue arises of how a recommendation of the European Comission is to be considered within the context of the legal system. A recommendation is a non-binding legal act directed to the member countries. They have the choice of whether to implement it or not. Nonetheless, binding implementation must indeed be expected, as it results in particular from the planned medical device regulation, which describes unannounced audits as follows: «The notified body shall randomly perform unannounced factory inspections to the manufacturer and, if appropriate, of the manufacturer's suppliers and / or subcontractors, which may be combined with the periodic surveillance assessment [...] or be performed in addition to this surveillance assessment.»1 If this proposal for the new medical device regulation is approved in this form, this means that regular unannounced audits will be binding. Note that this requirement can also apply to suppliers and subcontractors, including original equipment manufacturers (OEMs). It is thus very likely that an auditor will soon appear unannounced on your doorstep or on the doorstep of one of your major suppliers. Theoretically, this is already possible under the current directives under certain circumstances, but in practice it almost never happens. However, if unannounced audits are now not only possible but even required, it should be clear what the consequences of this requirement may be.

Focus on notified bodies
Due to incidents such as the Poly Implant Prothèse (PIP) scandal, the notified bodies have increasingly come under fire from the general public and are now under enormous political pressure. The pressure is intensified by the EU implementing regulation No. 920 / 2013. In particular, due to the new supervisory process, various notified bodies have already lost their accreditation or had it severely restricted since the implementing regulation took effect.

What this means for your company
Experience has shown that companies frequently undertake intensive preparations on a short-term basis for a scheduled inspection. Existing documentation, controls and monitoring are reviewed for topicality and validity and adapted if necessary. Employees are prepared for the procedure and it is ensured that the responsible persons are on site for the inspection. Unfortunately, experience has also shown that these preparations often do not produce the necessary sustainability over the long term and that the company falls back into old habits after the audit.

But what happens when a regulatory authority or notified body shows up unannounced and unexpectedly? It is conceivable that the person in charge is on vacation or ill, that documents cannot be found or contain major errors, employees are not prepared for possible requests and questions, or new requirements due to changes in the legislation may not have been incorporated in the company’s routine yet. Consequently, the companies will have to remedy numerous deviations, possibly critical ones, which would tie up a lot of resources and adversely affect their normal operations and / or new projects. In a worst-case scenario, product certification could also be revoked. In short, unannounced audits can have the same consequences as any scheduled audit, but companies will no longer be able to prepare for them, so that the actual status and thus compliance of daily operations with regulations will be audited. Instead of being able to prepare for such a visit, you will have to provide evidence that your routine operations also meet the requirements. Of course, the rules must first be formally documented. But a compliant routine means that these written rules are actually implemented in your daily work.

Experience of the Chemgineering Business Designers
The gap analyses of the Chemgineering business designers show that signatures on documentation are often not provided in a timely manner. Critical examples from practice include batch release records. Shortcomings include missing signatures or incoherent dates. These are added at a later point in time, even though a signature has already «sealed» the document. We have also observed that persons signing the document are not aware of the significance of their signatures. Time pressure leads them to approve a document negligently, without actually having reviewed it.

Unannounced audits eliminate the preparation time to review existing documents. You therefore need to ask yourself whether you would be able to pass an inspection at any arbitrary point in time. Specifically, this involves the following issues:
· Are your quality management and quality assurance systems seamless and sustainable?
· Are there formal rules for representation / deputization and is the necessary expertise of the relevant representatives regularly reinforced and enhanced with training courses?
· Does your company monitor the legal situation and implement new requirements effectively, efficiently and in a timely manner?
· Is your company audit-proof in practice at all times?

These are just a few of the questions we’d like to answer together with you. The Chemgineering consultants can take a look at the routines in your company for you. This could be done in the form of a classic gap analysis, or we could also simulate an unannounced audit from the standpoint of a strict, independent auditor. Furthermore, we offer seminars and workshops that develop interdepartmental expertise and that convey and enhance understanding of compliance. Our goal is to assist you in becoming sustainably compliant, so that you are well-equipped to deal with all eventualities, whether scheduled or otherwise.


1 Source: Proposal for a regulation of the European Parliament and of the Council on in
vitro diagnostic medical devices, Annex VIII, Section 4.4, 2012 / 0267 (COD) and
Proposal for a regulation of the European Parliament on medical devices, Annex VIII,
Section 4.4, 2012 / 0266 (COD).


Nina Hönig Junior Consultant, Medical Device Compliance
Chemgineering – The Business Designers



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