Manufacturer's MDR responsibilities

How does the MDR define the broader responsibilities for manufacturers and what does this mean for the industry?

What are manufacturer’s responsibilities under the MDR?

The medical device sector is one of the most highly regulated market sectors in the world. The introduction of the MDR — Medical Device Regulations (MDR) 2017/745 — sees the largest overhaul of medical device legislation in decades. From May 2021 the MDR will be fully in force and all medical devices and medical device manufacturers in the European Union will be subject to it. All activities – from device conception and design, through realisation, manufacture, device marketing and surveillance activities after release – will be governed by the MDR, with wider responsibilities for all economic operators within the market.

Because the scope of the MDR is broader than that of the existing MDD legislation, many manufactures may find themselves drawn into medical device legislation for the first time, while others who were familiar with the MDD may struggle to make the transition to the more extensive MDR legislative framework. Either way, the MDR represents a new challenge for many manufacturers.

In order to start working with the new legislation effectively, it is important to understand the full range of responsibilities of medical device manufacturers under the MDR. Article 10 MDR outlines the general requirements for all medical device manufacturers and other economic operators under the MDR.

Article 10 requires that all manufacturers must:

  • Ensure that their medical devices are designed and made in accordance with MDR
  • Have a risk management system in accordance with Annex I Section 3 of the MDR
  • Conduct an appropriate Clinical Evaluation of all their devices
  • Maintain a record of up to date technical documentation
  • Have access to a Person Responsible for Regulatory Compliance (PRRC)
  • Have an implemented Quality Management System (QMS)

If MDR compliance has been successfully demonstrated following a suitable conformity assessment (involving a Notified Body in many cases), manufacturers are required to affix a CE-mark to their devices and must comply with requirements for using a Unique Device Identification (UDI) system. They must also ensure that procedures are in place to ensure that device production continues to be in conformity with MDR as it scales, with any changes declared to regulators.

Let’s examine some of these manufacturer responsibilities under the MDR in detail.

Quality Management System

Manufacturers are required to establish, document, implement, maintain, update and improve their Quality Management Systems continuously
Fig 1: The information, processes, roles and responsibilities required in Quality Management Systems

Article 10 outlines requirements for the Quality Management System (QMS) that all manufacturers must establish. The QMS must cover all aspects of the manufacturer’s organisation, extending from basic corporate processes such as sourcing, to detailed procedures for product realisation and Post-Market Surveillance strategies.

The harmonised standard ISO 13485:2016, developed in reference to the MDD, outlines detailed requirements for quality management systems for medical devices. It is important to understand that the MDR contains additional obligations that extend beyond those outlined in ISO 13485:2016 in certain areas. Nonetheless, the ISO standard is an important source of guidance for manufacturers when building a QMS.

Person Responsible for Regulatory Compliance (PRRC)

Article 15 MDR states that every manufacturer must have access to a dedicated Person Responsible for Regulatory Compliance. This nominated person must take overall responsibility for regulatory activities at the company, and must be allowed to undertake their duties without prejudice, even if their proper activities may result in an action that is commercially disadvantageous to the company (for example, requiring withdrawal of a device from the market on safety grounds).

Most companies will be required to employ their own responsible person. However, the MDR does make allowances for small manufacturers who need not directly employ their own person but must have one “permanently and continually” at their disposal.

Unique Device Identification System

Articles 27-31 MDR require manufacturers to ensure that their devices can be uniquely identified according to a specific, EU-wide UDI system. The MDR also requires that manufacturers keep a record of the UDI of their devices and, for higher risk devices, maintain a record of where all devices have been sold to.

Clinical Evaluation and Clinical Investigations

It is a requirement that manufacturers conduct a Clinical Evaluation of all their medical devices; a process fed in part by data generated through clinical investigations undertaken by the company. A Clinical Evaluation must be summarised in a technical document known as a Clinical Evaluation Report (CER).

Clinical Evaluation draws generated data from general/device specifications, literature, Post-Market Surveillance, Post-Market Clinical Follow-up, Vigilance and Risk Management, which are used in the Clinical Evaluation Report
Fig 2: The activities that generate data required for Clinical Evaluations

Clinical evaluations and clinical investigations are defined in Article 2 MDR as follows:

  • Clinical Evaluation: Systematic and planned process to generate continuously, collect, analyse and assess the clinical data of a medical device in order to verify safety and performance.
  • Clinical Investigation: Any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a medical device.

Under MDR the stated objectives of Clinical Evaluation are:

  • To demonstrate conformity with the relevant General Safety and Performance Requirements (GSPRs - listed in Annex I)
  • To evaluate the presence and rate of undesirable side-effects
  • To determine the acceptability of the benefit-risk ratio of a device.

All manufacturers must plan, conduct and document a Clinical Evaluation following the process detailed in Annex XIV Part A.

Post-Market Surveillance (PMS)

Once a medical device has been released onto the market it is the responsibility of the manufacturer to constantly monitor its safety and performance through establishing and running a Post-Market Surveillance (PMS) system.

Manufacturers are required to establish, document, implement, maintain, update and improve their Post-Market Surveillance systems continuously
Fig 3: The processes required in Post-Market Surveillance

PMS, required by Article 93 MDR, is performed on a plan-implement-review-act basis and forms a key part of a manufacturer’s Quality Management System (QMS). Effective PMS systems contain multiple elements to ensure that comprehensive data is accumulated on the safety and performance of the device throughout its lifetime.

Vigilance is one arm of an effective PMS system and is ‘always open’ in order to react to events such as serious incidents or complaints. Post-Market Clinical Follow-up (PMCF) is another aspect of PMS that comprises the prospective collection of clinical data relating to the performance of the device following its release onto the market.

Market Surveillance is a form of device performance monitoring that is performed by competent authorities rather than manufacturers. It provides a ‘top down’ perspective on the safety and performance of each class of device.

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We have compiled some of our frequently asked questions. If you'd like to know anything else about what we do, feel free to ask us a question.

  1. We can work with the majority of medical device manufacturers seeking compliance of their devices in accordance with Medical Device Regulation (EU) 2017/745, including both hardware and software devices. We also offer a free, no-obligation consultation, so please feel confident about discussing your requirements with a member of our team.

  2. No. We will work with you to produce systems and to support your EU MDR compliance, but we do not conduct research ourselves. We will provide tools for you to conduct your own Post-Market Surveillance. Our range of services are designed to assist you in this matter.

  3. Yes. We adhere to the highest standards of professionalism and regard maintaining confidentiality and data security as a cornerstone of our practice. We also comply fully with the requirements of GDPR.

  4. Our medical device regulatory consulting is built around a strict quality framework and we only work with clients who share this commitment to quality. Our CEO is a medical doctor with years of experience in the medical device industry and assumes personal responsibility for every project. Our product development process integrates client feedback throughout product production, ensuring a constant focus on your needs.

  5. We work with clients of all sizes and at all stages of their regulatory compliance journey. Our team are here to help and are happy to respond to general enquiries, even if you don't feel like you know where to start. We are experts at 'tuning in' to your requirements and will guide you through the entire process. Our free MDR Compliance Guide and suite of MDR downloads stand as proof of our commitment to help you understand your obligations under the MDR.

  6. Yes. Software as a Medical Device is an increasingly-important segment of the medical device market. We have extensive experience in building regulatory systems for medical software and offer a special application of all our MDR services for software products. We also offer unique downloads and white papers that focus specifically on Software as a Medical Device.

  7. At its core, working with the MDR is about working with clinical evidence. Whether you need to generate evidence for PMCF, analyse data for writing a CER, or build an MDR-ready PMS system, our medical experts have the clinical acumen to ensure that your clinical evidence is produced and interpreted with the highest levels of professionalism. Medical professionals work with clinical evidence all day. We bring their specialist capabilities directly to your MDR strategy.

  8. We believe in transparency and aim to build long-term relationships with our clients. This commitment is demonstrated by our customer-focused pricing strategy. You pay a small deposit upfront, only paying the balance when the work has been completed to your total satisfaction. For higher-value projects we offer flexible payment packages on an individual basis — please contact a member of our team to find out more.

  9. Yes. Our unique business model allows us to scale to accommodate almost any amount of work. Many of our medical professionals remain clinically active, meaning that we have trained more than we presently need. This system allows us to have ready availability of redundant capacity that can be called upon in the event of a surge in demand. Whatever your requirements, our unique business model allows us to step in faster than any of our competitors.

  10. Yes. We run a number of events throughout the year focusing on specific aspects of MDR compliance. We also offer a limited number of free webinars on a limited basis — subscribe to our newsletter to be notified early when we publish new events. Of course, we also have our extensive MDR Compliance Guide and free MDR downloads suite, both of which offer extensive training on all aspects of MDR compliance.

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