By Jon Speer

Stakeholders in the medical device manufacturing sector, listen up: The European Medical Device Regulation (MDR) is a new set of rules that govern the production and distribution of medical devices in Europe—and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace. If your company was already compliant with the Medical Devices Directive (MDD), don’t be fooled into complacency—the MDR represents brand new regulations with a lot of changes.

As a starting point for medical device companies, this article will answer seven of the most important questions about the new MDR. We’ll cover why the old regulations needed an update, the structure of the new MDR document, and some of the latest requirements that medical device companies need to be aware of.

 1. Why Was the Update Necessary?

There were many reasons the MDD needed to be updated. For instance, when the MDD came into law in 1992, Software as a Medical Device did not yet exist. Software was something that controlled electric machines, and there were no apps that patients could use to monitor their own health.

The European demographic has also changed since 1992, with the population growing older—and there is a growing push for increased transparency of medical device technical information to the general public. The MDD’s new directive will encourage wider compliance with standardized medical device regulations throughout Europe.

2. What’s the New MDR Structure?

The new MDR document is 174 pages in length, with a 13-page introduction, followed by 123 articles in 10 chapters (79 pages), and 17 annexes (80 pages). Compared with the previous MDD, which was only 60 pages in length, the new regulations are much longer and more detailed. There have also been 42 implementing acts published, which are used to clarify/implement the MDR, and 12 delegating acts used to modify/amend it.

So, why is there so much new content? In addition to the integration of the Active Implantable Medical Devices Directive into the new MDR, new content has been created as well.

3. What Are the Major MDR Changes? 

Compared with its predecessor, the MDD, the new European MDR is less focused on the pre-approval stage of medical device manufacturing and, instead, promotes a lifecycle approach to medical device regulation.

While the old MDD essentially served as a manual for how medical device companies could get their CE marking and continue to market, the new regulations encourage policies and procedures that elevate the responsibilities of medical device companies for their products throughout the product lifecycle.

The European market comprises 27 member states (excluding the United Kingdom), along with others that fall into the European Economic Area (Liechtenstein, Norway, and Iceland). The region is inhabited by an aging population of 500 million people, and as populations age, they face greater risks associated with medical device malfunctions and adverse events. This is one of the main reasons that the regulations focus on product lifecycle, not just getting to market.

4. Which Devices Are Covered Under the MDR?

The MDR defines the term “medical device” as an “instrument, apparatus, appliance, software, implant, reagent, material, or other article” that is used for any of the following:

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease, disability, or injury, but not for disability or injury prevention
  • Investigation, replacement, or modification of an anatomical, physiological, or pathological process
  • Providing data via in vitro examination of samples derived from a human body

This definition covers a broad range of existing devices, but beyond that, the MDR newly specifies certain types of products that need to obtain a CE marking—for instance, products used to clean, disinfect, or sterilize medical devices, and devices used to control and support conception, whether through pharmacological, immunological, or metabolic means.

It is important to consult the regulations directly to determine whether your medical device is covered under the MDR. Even so, you may be spared some of the hardships of compliance depending on your device classification. Under the MDR, Class I devices are exempt from being required to have their QMS audited by a third-party auditor (notified body).

5. Will the MDR Require Enhanced Device Traceability?

Yes. The new MDR includes a mandate for Unique Device Identification (UDI) that is intended to facilitate the traceability of all medical devices sold in the region. Devices must be marked with a device identifier and each batch or production series of the product will be marked with a production identifier.

The MDR also introduces new databases for clinical investigations, product registration, and post-market surveillance. The EUDAMED database will function as part of a system of several databases that allows notified bodies, medical device companies, consumers, regulators, and other stakeholders to access the latest data on medical devices for sale in Europe.

6. How Will the MDR Affect CEO Markings?

Right now, the new MDR is not having a significant effect on obtaining a CE marking. Although the final document was published in May 2017, the regulations will not come into force until May 2020, leaving medical device companies ample time and opportunity to achieve compliance.

Medical device companies can still receive compliance certification from notified bodies up to the effective date of May 26, 2020, and these certificates will remain valid for five years from the date of issuance, allowing for a smooth transition period. Devices that are legally placed on the market before the effective date can be sold until five years after the MDR takes effect, but their compliance certificates will all become void on May 25, 2024.

 7. How Will the New MDR Affect the QMS

Once the new MDR goes into effect in May 2020, any and all previous “directives” will no longer exist or be applicable to quality systems. Instead, they will be called a “regulation,” which carries a more substantial meaning. The changes will be considered laws, similar to FDA medical device regulations. Manufacturers must also follow “general obligations” to ensure compliance for their quality management systems (QMS).

As stated in the MDR guidance, manufacturers shall establish, document, and implement a quality system and maintain its effectiveness throughout the entire device lifecycle. A strong emphasis will be placed on the management functionality of the QMS for required procedures with document storage, post-market surveillance, and risk assessments of new and existing devices.

During QMS implementation, manufacturers must include documentation in the form of a quality manual and written policies/procedures, including:

  • Quality objectives
  • Organization of the business
  • Procedures/techniques used for design control, verification, validation, and review of the device(s)
  • Quality assurance and verification procedures during manufacturing stage
  • Relevant tests and trials

If manufacturers plan to implement a new quality system, they must submit “an application for assessment of its quality system with a notified body” (excluding Class I devices). The documentation of the application must also include:

  • The specific manufacturer’s current QMS and the procedures used to ensure adequacy and efficacy
  • The manufacturer’s post-market surveillance system and clinical evaluation plan, along with descriptions of both of those procedures to ensure they will be kept up to date
  • Current procedures being used to meet both QMS and medical devices regulations/in vitro diagnostic device regulations must be documented, along with descriptions of each.`

Come 2020, the three-year transition period will come to an end. And after May 26, 2020, manufacturers must implement all new QMS regulations for each device to be sold in the European Union.

Summing It Up

The European MDR is a taste of how the regulatory environment for medical devices will be changing over the next decade. The newly published ISO 13485:2016 and the FDA’s Medical Device Single Audit Program program are already pushing for greater standardization and stronger post-market surveillance requirements, along with process-oriented risk management and a lifecycle approach to device management.

Although the effective date for the MDR feels far in the future, compliance today promises to set your medical device company up for long-term industry prosperity and unprecedented success in meeting regulatory compliance objectives in valuable markets around the world.

Jon Speer, is founder and vice president of quality assurance/regulatory affairs at Greenlight Guru. Questions and comments can be directed to chief editor Keri Forsythe-Stephens at [email protected].