The EU Medical Device Regulation 2017/745 (MDR) and In-Vitro Diagnostic Regulation 2017/746 (IVDR) lay out what are known as the ‘General Obligations of Manufacturers’ in Article 10. The 16 paragraphs of this Article encompass the main requirements for compliance with the EU Regulations, from a manufacturer’s perspective, and are a good starting point to understanding the Regulation as a whole. As suggested by its title, Article 10 acts as a contents list to the most relevant topics which manufacturers must understand within the Regulation; it provides reference to the more specific requirements which will need to be met.
In this post, we intend to further clarify some of the main points of Article 10.
QUALITY MANAGEMENT SYSTEM
Article 10 will have great implications on your Quality Management System (QMS). In fact, it is now clear that all manufacturers must operate a QMS; whether or not this QMS will need to be assessed by a third party depends on the chosen route of conformity for that particular device. E.g. devices which are Class I medical devices (not sterile, not measuring, not a reusable surgical instrument) will not need to have their QMS assessed and certified (although they may still wish to do so). On the other hand, higher risk devices conforming to the requirements of Annex IX, will have their QMS assessed as part of their EU certification application.
Specifically, Article 10(9) states:
Manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.
This paragraph goes on to describe which aspects shall be addressed by the QMS, including:
- Strategy for regulatory compliance.
- Identification of applicable General Safety and Performance Requirements (GSPR).
- Responsibility of management.
- Resource management.
- Risk management.
- Clinical/performance evaluation and Post-Market Clinical/Performance Follow-up.
- Product realisation.
- Verification of Unique Device Identification (UDI) assignments.
- Post-Market Surveillance (PMS) system.
- Communication handling.
- Vigilance.
- Corrective and preventive actions.
- Monitoring and measurement of output, data analysis, and product improvement.
For those manufacturers who already have a compliant ISO 13485:2016 QMS in place, there are still certain elements from the above list which will need to be taken into consideration. For example, the identification of applicable GSPR or a strategy for regulatory compliance, and UDI verification may be new aspects to your existing QMS. Keep in mind that the EU Regulations have also effectively updated or clarified previous requirements from the Directives (e.g. the timelines for reporting incidents).
In updating your existing QMS, we recommend that you refer to EN ISO 13485:2016+A11:2021. Annexes ZA and ZB of this harmonised standard provide an excellent comparison between the requirements of ISO 13485:2016 and the MDR and IVDR, respectively. This will be a crucial tool in ensuring your QMS complies with the Regulation requirements.
For device manufacturers who have previously not required a QMS, the aforementioned standard will also be helpful in setting up a robust QMS; however, it should be stressed that the QMS for devices outside of the conformity assessment routes requiring Notified Body intervention will not need to be certified. Furthermore, as quoted above, the QMS shall be implemented in the “most effective manner and in a manner that is proportionate to the risk class and the type of device”.
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TECHNICAL DOCUMENTATION
One of the main obligations highlighted in Article 10 is to “draw up and keep up to date technical documentation” for the devices produced by the manufacturer and which must meet the elements set out in Annexes II and III of the Regulations. Although it has always been the case, the Regulations are very clear in that all manufacturers shall draw up technical documentation for their devices, regardless of their classification. The overall risk of the device does have implications on the extent of preparation of the document, with lower-risk products requiring less data to demonstrate safety and performance. However, all products must be accompanied by the documentation in Annexes II and III. Some specific elements mentioned in Article 10 which may apply to the technical documentation include:
- Design and Manufacture.
- Risk Management.
- Clinical Evaluation (MDR) and Performance Evaluation (IVDR).
- Post-Market Clinical Follow-up (PMCF) (MDR).
- Post-Market Performance Follow-up (PMPF) (IVDR).
- Post-Market Surveillance.
- Information Provided by the Manufacturer.
- Annex XIII documentation (MDR, Custom-Made).
- EU Declaration of Conformity.
A common misconception is that low-risk devices do not require a clinical evaluation or performance evaluation. Although there may be no need to conduct clinical investigations to demonstrate safety and performance, a Clinical Evaluation Report (CER) or Performance Evaluation Report (PER) (for IVDs) will still need to be put together, taking into account elements such as device background and state of the art, analysis of post-market data, and literature review.
This documentation shall be kept available for competent authorities for a period of at least 10 years after the last device has been placed on the market. For implantable devices, the period shall be at least 15 years.
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UDI AND REGISTRATION OBLIGATIONS
Article 10 briefly indicates that manufacturers shall meet their obligations for the assignment of UDI and their registration obligations, as detailed further in Article 29 and 31 of the MDR and Article 26 and 28 of the IVDR.
Article 27 of the EU MDR and Article 24 of the EU IVDR describe the Unique Device Identification system, which is new for European regulation of such devices. If you haven’t already done so in other jurisdictions, you will need to assign a UDI to each of your devices and their higher levels of relevant packaging. The transitional deadline to show the “UDI carrier” on the device or packaging itself will depend on the device classification. See our article on UDI, here.
All manufacturers selling in the EU will also be required to meet registration obligations of both their organisation and their devices on the Eudamed system. Manufacturer’s must go through a process known as Actor Registration in order to obtain their Single Registration Number (SRN), a unique code identifying their Actor on Eudamed. Furthermore, the manufacturer then has an obligation to register all devices being placed on the EU market on Eudamed.
Although these obligations are technically not enforced until 6 months after a notification has been made in the Official Journal of the EU (OJEU) that Eudamed is fully functional, it is recommended to begin the process sooner rather than later.
For more information on Eudamed and Eudamed registration, click here. Get in touch to see how we can help you with this obligation.
COMMUNICATION AND VIGILANCE
All manufacturers are obliged to ensure that the devices which they are placing on the market are safe and perform as intended. If they become aware that a device which they have placed on the market is not in conformity with the Regulation, or if the product presents a serious risk, the manufacturer must take all necessary steps to remove the product from the market and communicate with the relevant authorities. In doing so, manufacturers must have a robust vigilance and reporting system in place to enable them to act quickly in case of reportable incidents or complaints.
In such cases, the manufacturer is required to provide the competent authorities with the information and documentation necessary to demonstrate the conformity of the device. This may also require the documentation to be translated in a language as requested by the authority.
OTHER OBLIGATIONS
Article 10 only provides a general understanding of the manufacturer’s obligations and points to other areas of the Regulation which will need to be addressed. There are some obligations and requirements which are not specifically mentioned in Article 10, such as:
- Designation of an EU Authorised Representative [Article 11]. See more information, here.
- Requirements related to importers and distributors.
- Person Responsible for Regulatory Compliance (PRRC) [Article 15].
- Systems and procedure packs, if relevant (MDR Article 22).
- Medical device nomenclature, e.g. EMDN.
