Second in a 7-part series on the EU’s Medical Device Regulation

The new Medical Devices Regulation (2017/745/EU), or more commonly referred to as the EU MDR, poses significant challenges to medical device makers that want to market their products in the European Union.

The clock is already ticking and the three-year transition period is counting down to 26 May 2020, which is the “Date of Application” (DoA) of the Regulation.

From that date, the MDR will apply fully however if a device is still certified under MDD, then only sections of the MDR will apply (for example, post-market surveillance requirements). Consequently, if your company has not already started, the time to act is now.

Because of the complexity of the changes, many experts including Kapstone Medical recommend a structured enterprise-wide approach pulling together a multi-disciplinary and cross-functional governance and program team with C-suite leadership fully engaged.

In a report to medical device makers, Deloitte suggests a 3-step process for getting ready for the EU MDR:

Step 1 – Understand the EU MDR

Step 2 – Conduct a review and assessment of your medical device portfolio

Step 3 – Draw up an EU MDR strategy and roadmap

Step 1 – Understand the EU MDR

It’s important to understand that the MDR imposes a number of obligations on manufacturers. According to a European Commission fact sheet, these include implementing systems for risk and quality management, conducting clinical evaluations, compiling technical documentation, and applying a conformity assessment.

Device makers are also responsible for their devices once they are on the market and must have systems in place to cover financial responsibility for harm caused by defective or malfunctioning devices. Each device must have a Unique Device Identification (UDI) that should be compatible with the FDA system. This will require an update to the current Eudamed database

Other obligations include significant changes, such as having a designated person responsible for regulatory compliance, as well as lesser requirements, such as providing an implant card for patients for implantable devices.

Clinical requirements

Under clinical requirements, the new Regulation requires clinical evaluation including collection of clinical data already available in the literature as well as ongoing clinical investigations. Clinical data for devices that already exists can still be used for an equivalent device. However, there are a limited number of situations where equivalence applies and the new rules are stricter. In addition, new and more precise clinical investigations are required.

There are additional clinical requirements for Class III and implantable devices for safety and performance summaries in lay terms as part of the technical documentation sent to the Notified Body.

Once all obligations are met, you need a declaration of conformity and an application for CE marking. Manufacturers outside the EU need to have a contract with an authorized representative inside the EU who also has specific obligations to comply with.

Post market surveillance (PMS)

Another significant shift of EU MDR is more rigorous post market surveillance requirements include PMS planning and implementation, vigilance reporting, Periodic Safety Update Reports (PSURs), and handling field safety corrective actions. Also, the timeline for adverse event reporting is decreased from 30 days to 15 days.

Step 2 – Conduct a review and assessment of your medical device portfolio

Review your portfolio of products to determine which will be reclassified or will need to be examined by a Notified Body. Under the MDR, determining risk classes is essential in specifying the steps needed for CE marking.

Notified Bodies

Notified Bodies have to be designated under the MDR. For manufacturers new to the EU, Notified Bodies can be difficult to understand and is one of the most significant differences between the EU and FDA approvals.

A Notified Body is an independent certification organization that is “notified” by a European Member State’s Competent Authority to determine if a product or system meets applicable requirements for CE marking.

Because the process of designation involves assessors from different national and European authorities it may take 12 months or more. To check which countries have qualified Notified Bodies, you can check the NANDO database (New Approach Notified and Designated Organizations).


The European Commission mandated that all Competent Authorities in the EU use the Eudamed databank for medical devices as of May 1, 2011. To handle all of the requirements of MDR, the commission committed to building Eudamed into much more robust database for monitoring and data collection, which is expected to go live in March 2020.

The complex data system is intended to consist of seven databases that will track economic operators, devices, Unique Device Identification (UDI), Certificates, Clinical and Performance Studies, Vigilance Data, and Market Surveillance.

When the database is operational, device makers will be required to supply and maintain labeling, perform data submission, and provide storage/traceability and UDI information.

While the project is considered feasible, even if it is completed on time, experts say it is far from certain that all economic operators will be able to get access to the database in time. Until Eudamed is fully operational, it is expected that some parts of the Directives will have to substitute for the corresponding requirements of the Regulation. These include the registration of devices and economic operators. In addition, a person responsible for regulatory compliance needs to be available but not necessarily registered until Eudamed is operational.

Step 3 – Draw up an EU MDR strategy and roadmap

With your full portfolio review and assessment complete, you should be able to identify any gaps which can be used to draw up a strategic projects list around your clinical evidence requirements, product safety, quality management system, and supply chain, based on business, legal, and regulatory concerns.

As an example, the new regulation will require stronger controls in your supply chain management to ensure traceability and transparency. This will require a stronger system to ensure proper labeling and packaging

Your strategy for safety and post-market surveillance will need to address more stringent product safety requirements, including more thorough monitoring and risk-management systems. Your quality management system will need to establish, document, implement, and maintain product conformity and quality.

You will need to strengthen your clinical data documentation to include more information supporting quality, performance, and safety data. The inclusion of data from clinical investigations will become mandatory for new Class III or implantable medical devices.

In short, readjusting your strategy and planning for implementing systems to meet the new regulations is likely to involve substantial resources and may require a change to your business case along with stronger project and stakeholder management.

If you are looking for help with MDR, Kapstone Medical has the experience and expertise of medical device manufacturer requirements from submissions to compliance. Contact us for more information.


Sources: Euro-Lex Document 32017R0746; Deloitte: Preparing for the future: The new European Union medical devices regulation; European Commission: Fact sheet for Manufactures of Medical Devices

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