Impact of the MDR on Quality Assurance Agreements (QAA)
Quality assurance agreements (QAAs) are often an unpopular topic. At some point a QAA, accompanied by a business partner was concluded and implemented. Afterward, they became forgotten and outdated. In this article, we show why a QAA is an important and central tool for a manufacturer and why it is worth checking that it is up-to-date with the MDR and adapting it to current regulatory requirements.
The QAA as a core document of the quality management system
Manufacturers of medical devices still need a quality management system (QMS) with Regulation EU 2017/745 (MDR) to be allowed to place their medical devices on the market. According to Article 10 of the MDR, this must be implemented, documented, applied, maintained, constantly updated, and continuously improved. The central standard for quality management systems for medical device manufacturers is EN ISO 13485: 2016. In this harmonized standard, the manufacturer comes across the concept of quality agreements for the first time. According to point 4.1.5 of DIN EN ISO 13485: 2016, a manufacturer must introduce control measures, if he intends to outsource a process from his organization that can influence the product conformity with the requirements of the product. In practice, this can be, for example, the processes of physical contract manufacturing (either completely or just a part of manufacturing) or sales. The manufacturer is still responsible for those processes and must therefore monitor and ensure the control of the outsourced processes. EN ISO 13485: 2016 requires that the control measures contain written quality agreements.
Thus, the manufacturer who has a QM system according to EN ISO 13485: 2016 should have quality assurance agreements (QAA) in place. They should regulate the obligations, delimitation of responsibilities, and interfaces between the economic actors and record them in writing.
Different times of the QAA adjustments are possible
The current QAA must now be checked and adapted concerning new MDR requirements. It should be noted that there may be different implementation times depending on the requirements and the type of medical device. As a rule, the requirements of the MDR are to be implemented with the certification of the product according to the MDR and these are to be defined in the QAA. For medical devices that have a valid certificate according to Directive 93/42 / EEC (MDD) and for which no significant product changes are made, the transitional provisions according to Article 120 of the MDR can be applied. This means that the manufacturer may place these products on the market under MDD requirements even after the MDR has come into force. However, this is possible to a limited extent until May 26, 2024. For these "legacy devices", the MDR requirements for the product only apply with the initial certification of these products according to the MDR, so that an adjustment of the QAA in this regard may only be necessary at this point.
Exceptions to this, however, are the requirements named under Article 120 (3) of the MDR, which must be implemented for all medical devices, i.e. also for products still certified under MDD. This means that since the MDR came into force on May 26, 2021, the requirements of the MDR for post-market surveillance (Article 83-86), market surveillance (Article 93-100), vigilance (Article 87-92), and registration of economic operators and of products (Articles 29-31) are to be applied. These requirements should be reflected in the QAA at this point.
Review of fixed deadlines in the QAA
Taking into account the requirements in Article 120 (3) of the MDR, the manufacturer should check possible defined deadlines in the existing QAA with his partners to ensure that they are up to date. Article 87 of the MDR on vigilance provides a central shortening of the deadline for the manufacturer. This article now only gives the manufacturer a maximum of 15 days to report a serious incident to the competent authority, except in the case of a death or a serious risk to public health, so that shorter deadlines apply. Under the MDD, the manufacturer previously had twice the reporting deadline of a maximum of 30 days. It is now advisable to adapt existing deadlines in the existing QAA in this regard or possibly even to add new ones. The manufacturer must ensure that in these vigilance cases he receives all the information or necessary preparatory work from his partners in good time for his assessment so that he can meet his reporting deadlines to the competent authority.
Which aspects still need to be considered?
Consistent use of terms
Depending on the constellation of economic actors and the type and scope of the outsourced process within the supply chain, the QAA must be individually adapted. In general, the QAA should be revised to the new definitions according to Article 2 of the MDR. For example, the terms “serious incident”, “dealer” or “importer” are used to describe the manufacturers that did not explicitly exist under MDD. These terms need to be defined in the QAA so that there is clarity in this regard for all partners involved.
Identification of all economic operators
The roles and tasks of the respective economic operators should be identified and coordinated so that they can be recorded in writing. It is not important to transfer the pure text from the MDR into the QAA but to adapt it individually to the respective constellation and type of the outsourced process.
Person Responsible for Regulatory Compliance (PRRC)
It is also advisable to name the manufacturer's new responsible person (Person Responsible for Regulatory Compliance (PRRC)) under the responsibilities in the QAA so that it is clear to all those involved to whom critical information must be reported. In this way, the manufacturer can ensure that his PRRC can meet its obligations to observe and control the requirements specified in Article 15 of the MDR.
Unique Device Identification (UDI)
Another new topic is UDI labeling. In the case of an outsourced contract manufacturing process, it is advisable to agree with the contract manufacturer who has to assign, attach, change, register, check, etc. the UDI.
Auditing by the manufacturer and its notified body
The right or obligation of the manufacturer to check the outsourced processes as part of an on-site audit should also be recorded in the QAA. The manufacturer's notified body may also audit the suppliers or subcontractors who take on outsourced processes for the manufacturer, even in unannounced form, within the scope of its inspection obligation in accordance with Annex IX, Chapter I, Paragraphs 3.3 and 3.4 of the MDR. It is advisable to include these requirements in the QAA so that the subcontractor knows this right of the notified body and acts accordingly in the event of an audit. Experience has shown that precisely this definition in the QAA is checked by notified bodies as part of the manufacturer's audit.
These aspects are only a selection of general new topics that should be taken over from the MDR into the QAA. Depending on the constellation of economic actors and the outsourced process, there are additional requirements.
Summary
The quality assurance agreement (QAA) should be checked as a required control measure for monitoring and securing outsourced processes by the manufacturer to ensure that it is up-to-date and adapted to the new requirements of the MDR. The times at which the various requirements and medical devices are implemented must be taken into account. The requirements according to Article 120 (3) of the MDR should already be explicitly part of the currently valid QAA, as these have to be implemented in regulatory terms since the MDR came into force on May 26, 2021. With an up-to-date QAA, which regulates the current regulatory obligations, delineations of responsibility, and interfaces between the economic operators and sets them down in writing, the manufacturer can ensure compliance with his obligations following Article 10 of the MDR. The top priority, however, is that the QAA is also lived by all those involved.
qtec as your Partner
As a partner in the medical device field, qtec is happy to support you with questions on this topic or with the adjustment of your quality assurance agreements (QAA) to meet the currently applicable regulatory requirements.
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We have in-depth expertise in the approval of medical devices worldwide. Ask us your questions - we will give you concrete answers and put together a project team for you on request.
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