In the European Union, the legal manufacturer is understood to be the entity which has the final responsibility for the device being placed on the market. It doesn’t necessarily mean that they physically manufacture or even design the product even though they are indicated on the labelling near the little factory symbol!
Although manufacturers have always needed to abide by certain rules and meet certain requirements, the EU Medical Device Regulation 2017/745 (MDR) and IVD Regulation 2017/746 (IVDR) have done a terrific job of clearly listing out these obligations in Article 10. Understanding this specific Article is key to complying with the EU Regulations, and we strongly suggest that each stakeholder (including importers and distributors) read and recognise what requirements the manufacturer must comply with.
In Brief #
Article 10 spells out the “General Obligations of Manufacturers” of medical devices and IVDs, in both the MDR and IVDR respectively, and can be more or less split into the following sections:
|MDR Article 10 Par.
|IVDR Article 10 Par.
|Design & Manufacture
|Clinical Evaluation & PMCF
|Performance Evaluation & PMPF
|EU Declaration of Conformity & CE Marking
|UDI & Registration
|Document Retention & Provision
|Quality Management System
|Post-Market Surveillance System
|Labelling, IFU, & Translations
|Vigilance, Reporting, & Related Provisions
|Subcontracting Design or Manufacturing
Further specific obligations and requirements related to the above sections are strewn around the Regulations however, it is worth mentioning the requirement to appoint an EU Authorised Representative [Article 11] and a Person Responsible for Regulatory Compliance (PRRC) [Article 15].
Meeting these obligations is no mean feat and requires commitment and determination from the manufacturer. Initial compliance with the above sections may be a big challenge to surmount, however, maintaining your compliance should be much easier, with the right procedures in place.
Technical Documentation #
A big portion of Article 10 is related to the obligations set upon the manufacturer which can be demonstrated by the documentation required in Annexes II and III, i.e. the technical documentation, for that device. However, the addition of these specific paragraphs in this Article is a clear indication that Design and Manufacture, Risk Management, Clinical/Performance Evaluation, and PMS are elements that all manufacturers must take into consideration. Therefore, in order to continuously meet these obligations, we suggest that your design process specifically takes into account these regulatory requirements.
Much of these paragraphs will be covered by the technical documentation which must be prepared for each device and supported by the Quality Management System.
For more details on technical documentation, see our dedicated article here.
Quality Management System #
Throughout the EU Regulations, and specifically in Article 10, manufacturers are obliged to operate a Quality Management System, regardless of the risk classification of the device being placed on the market. This means that manufacturers of low-risk devices which were “self-certified” under the EU Directives are now required to set up a Quality Management System. Nevertheless, one must keep in mind that this should be prepared to an extent relative to the risk of the device and does not need to be certified by an assessment body. For manufacturers who were already utilising a compliant QMS (e.g. ISO 13485), they must take into consideration any deviations or additions to their existing system as may be required by the EU Regulations.
If this has not been taken into account yet, we encourage manufacturers to carry out a gap assessment of their existing system against the requirements of the EU Regulations. One helpful tool would be to use Annexes ZA and ZB of EN ISO 13485:2016+A11:2021 to identify any gaps in compliance with the EU MDR and IVDR respectively. In many cases, requirements put forward by the Regulations are fully or partially covered by a compliant ISO 13485 system. However, there are certain requirements, such as those related to risk, which need to be addressed in accordance with the Regulations.
The vigilance, reporting, and communication will also be covered by the manufacturer’s QMS and it is crucial that any such procedure clearly highlight the requirements of the EU Regulations as indicated within Article 10, and more specifically within Chapter VII of the EU MDR and IVDR.
See our Quality Management System related services, here.
Strategy for Regulatory Compliance #
A Quality Management System should have processes in place to ensure that it remains compliant with the ever-changing regulatory requirements. Typically, an ISO 13485 system should be able to identify such changes and analyse the impact they will have on the overall QMS or product. In transitioning your QMS to meet the requirements of the Regulations, we suggest that manufacturers put together a specific procedure for identifying and tackling regulatory changes. This should include typical resources which may be checked periodically to identify changes, such as:
- Official EU Guidance Pages [e.g. MDCG].
- Professional Networks.
- Regulatory News Websites / Newsletter.
Those sections of the system which may come into play in the event of significant changes should also be indicated, for example:
- Design Control.
- Control of Documents and Records.
- Technical Documentation.
- Post-Market Surveillance Procedure.
- Management Review.
For significant changes in regulation, the procedure may also require that you develop a written strategy to work towards. Since the manufacturer is presumably also transitioning to meet the requirements of the regulations, we do suggest putting together an MDR Transition Strategy/Plan and keeping this on record in the event it is requested by a Notified Body or EU Competent Authority.
It is no surprise that the subject of translating information provided to the user is brought up within Article 10 as it is oftentimes an overlooked requirement which we are seeing an increasing amount of manufacturers being cautioned on. The legal manufacturer must ensure that all information provided for the safe use of the device is translated into a language that the intended user understands and as required by the national law of the country in which it is being marketed. This is usually something which can be translated professionally by a translation company and then validated by a typical end-user or even the importer/distributor. In all cases, the validation of the translated information should be recorded.
Product Liability #
Article 10 makes it very clear that manufacturers will be liable for defective devices being placed on the EU market. Furthermore, it requests that organisations ensure they have sufficient financial coverage in place with respect to liability issues. Therefore, it is seen as a requirement that manufacturers either provide a certificate of Product Liability insurance with sufficient coverage or provide evidence of their financial ability to cover any liability issues.
How We Can Help #
The obligations of medical device manufacturers can be difficult to understand, making compliance that much harder. We offer a variety of services which can help manufacturers meet these regulatory obligations and succeed on the EU market:
Visit our service pages or get in touch today to learn how we can help you!