Medical Device Manufacturers

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 EU 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

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 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.

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.