Enter global markets by complying with applicable medical device certification standards
On 24th September 2013, the European Union Commission published a recommendation regarding assessments and audits to be performed by Notified Bodies in the field of medical devices field. A key aspect of this recommendation is the mandatory requirement of unannounced audits for all CE certified manufacturers at least once in every third year.
As of 15 June 2016, the German Federal Ministry of Justice and Consumer Protection published with an announcement that for non-implantable class IIb devices and class IIa devices as well as for IVD products, a time frame of five years might be sufficient.
In 2014, various European authorities such as the Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) of Germany and the Medicines and Healthcare products Regulatory Agency (MHRA) of UK required that Notified Bodies fully implement their unannounced audit programs.
Although the basic requirement is one unannounced audit per certification every third year, the frequency of unannounced audits can be increased for the following reasons:
Therefore, it’s important for manufacturers to assess their devices to anticipate the frequency of unannounced audits a particular device category may have. We recommend that manufacturers estimate the likelihood of the frequency of these audits based on the factors mentioned above for each CE certified device category in their product portfolio.
There are a few aspects to consider when preparing for unannounced audits. A team of at least two auditors will be on site for at least one full day. An unannounced audit may last multiple days. Key processes such as design control, establishment of material specifications, purchasing and control of incoming material and components, assembling, software validation, sterilisation, batch release, packaging and product quality control will be carefully examined. This list is not an exhaustive list and other relevant processes may be examined as well.
In addition to the production process, the unannounced audits will also focus on the product. Product samples may be chosen during the unannounced audits for further inspection and testing. A specific test plan can be planned by the Notified Body prior to the unannounced audit. The Notified Body may take product samples with them for further testing. In the case where finished devices are purchased (OEM) and sold under the manufacturers name (PLM), the Notified Body may also conduct an unannounced audit on the facilities of the OEM.
It is critically important that manufacturers are prepared for unannounced audits at any point in time. Unannounced audits will play an important role in the manufacturers ability to maintain and renew their certification. Due to the unannounced nature of the audits, the manufacturer must have policies and procedures in place when the unannounced audit team is present at their premises.
As the unannounced audit will likely disrupt the day-to-day operational activities, the manufacturers should prepare procedures to minimise impact to operational activities in the event of an unannounced audit.
Key managers and employees that are required for the unannounced audit should be present or should be contactable or accessible in short notice.
Manufacturers should consider establishing deputies or representatives for important roles required for the unannounced audit.
Communication between manufacturers and OEMs should be strengthened in order to facilitate unannounced audits with OEMs.
Manufacturers should take the responsibility to ensure that OEMs are fully aware and prepared for unannounced audit because their performance will have an impact on the manufacture’s ability to maintain and renew their CE certification.
In the past, manufacturers were commonly only required to conduct an initial audit, surveillance audits and re-certification audit. With the introduction of mandatory unannounced audits, manufacturers will have to incur the expenses due to additional unannounced audit every three years. This cost will increase with additional unannounced audits. Additional unannounced audits may occur if the device under certification bears a high risk, is frequently noncompliant, or where specific information provides reasons to suspect non-conformities of the devices or their manufacturers.
Unlike a regular audit, there won’t be an opportunity to specifically prepare for unannounced audits. Therefore, manufacturers must be ready for an audit at any point in time. Detailed policies and procedures need to be drafted and implemented by manufacturers to ensure that their staff are informed, trained and prepared for unannounced audits.
Manufacturers should take extra measures to ensure a closer communication and coordination with their critical subcontractors/suppliers. With the introduction of the mandatory unannounced audits, critical subcontractors/suppliers will play a larger role in the CE Certification process.
As the leading Notified Body in the medical device industry, TÜV SÜD takes a proactive approach in informing our customers about the regulatory changes related to unannounced audits:
Our unannounced audits Frequently Asked Questions (FAQs) cover extensive information about unannounced audits for medical device manufacturers. This includes general questions as well as specific questions related to the various aspects of unannounced audits. It is intended to serve as an informational resource that manufacturers can utilise to optimally prepare for unannounced audits.
To learn more, download the FAQs.
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