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Jon Speer

FDA Compliance

Eight Things You Need to Know About the European Medical Device Regulation

Setting up for long-term success

Published: Tuesday, June 4, 2019 - 12:02

The European Medical Device Regulation (MDR) is a new set of regulations that governs 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 significant changes.

For those seeking to better understand why the regulations have changed, and what some of the major changes are, let’s take a look at some of the most common questions we hear from our users.

1. Why did the MDD need an update?

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 (SaaMD) did not yet exist. Software was something that controlled electric machines, and apps that patients could use to monitor their own health were still nearly 20 years away.

Demographics have also shifted in Europe during the past 30 years; the population is growing older, and there is a greater push for transparency and standardization of medical device technical information and regulations throughout Europe.

2. How is the new MDR structured?

The MDR document is 174 pages and contains a 13-page introduction, followed by 123 articles split into 10 chapters (79 pages), and 17 annexes (80 pages). Additionally, the document contains 42 implementing acts, which are used to clarify and implement the MDR; and 12 delegating acts, used to modify or amend it. Compared with the older MDD, which was 60 pages in length, the new regulations are much longer and more detailed. Finally, the Active Implantable Medical Devices Directive (AIMD) has also been integrated into the new MDR.

3. What are the major thematic changes in the MDR?

The old MDD essentially served as a go-to-market manual for medical device manufacturers seeking their CE marking. The new MDR promotes a life cycle-focused approach that puts greater responsibility on device makers throughout the life of a product.

The European Common Market consists of 28 member states and three additional states that fall into the European Economic Area (Liechtenstein, Norway, and Iceland), each of which fall under the MDR. The region is inhabited by an aging population of more than 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 life cycle, not just getting to market.

4. What devices are covered under the MDR?

The MDR defines “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 that’s not all. The MDR newly specifies certain types of products that must obtain a CE marking, including products used to clean, disinfect, or sterilize medical devices, as well as 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, called a notified body.

5. What devices are covered under Annex XVI of the MDR?

The new MDR contains a total of 16 annex sections, and the one creating the most buzz is Annex XVI. This section mandates that certain devices are covered under the MDR—including ones that may not have previously been considered “medical devices.” As a result, some companies are being subjected to medical-device compliance regulations for the first time.

Annex XVI mandates that the following groups of products comply with the requirements of the MDR:
• Contact lenses and other products used in or on the eye (this would include eye drops and cosmetic contact lenses)
• Products introduced into the body via surgically invasive means to modify the anatomy (silicone breast implants would now qualify)
• Products and substances used for facial or other subcutaneous fillings
• Equipment used for liposuction, lipolysis, or lipoplasty
• High-intensity radiation equipment used for tattoo and hair removal
• Equipment using electrical or magnetic currents to stimulate the brain

Annex XVI now regulates devices that avoided regulation due to their cosmetic, not medicinal, applications.

6. Will the MDR require enhanced device traceability?

Yes, it will. The new MDR mandates a Unique Device Identification (UDI) intended to facilitate the traceability of all medical devices sold in the region. Devices must be marked with a device identifier (DI), and each batch or production series of the product will be marked with a production identifier (PI).

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.

7. How will the MDR affect CE markings?

As of right now, the new MDR is not having a significant impact on obtaining a CE marking. The regulations do not go into full 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.

8. How will the new MDR affect my QMS?

Once the new MDR goes into effect in May 2020, any and all previous “directives” will be deprecated and no longer applicable to quality systems. Instead, they will have a new name—i.e., “regulations”—and carry a much more substantial meaning. They will be considered laws, similar to FDA medical device regulations.

Manufacturers shall follow what is now known as “General Obligations” to ensure compliance for their quality management systems (QMS); this comprehensive list can be found in Article X of the new MDR.

As stated in the MDR guidance, manufacturers shall establish, document, and implement a quality system, and maintain its effectiveness throughout the entire device life cycle. There’s also a strong emphasis placed on the management functionality of that QMS for required procedures with document storage, post-market surveillance and risk assessments of both new and existing devices.

During QMS implementation, manufacturers must include documentation in the form of a quality manual and written policies and/or procedures, including:
• Quality objectives
• Organization of the business
• Procedures and techniques used for design control, verification, validation, and review of the device(s)
• Quality assurance and verification procedures used during the manufacturing stage
• Relevant tests and trials

In the event a manufacturer plans to implement a new quality system, it must submit an “application for assessment of its quality system with a notified body” (excluding Class I devices). Documentation of the application must include:
• Manufacturer’s current QMS and the procedures used to ensure adequacy and efficacy
• Manufacturer’s QMS system and clinical evaluation plan, along with descriptions of both of those procedures to ensure these will be kept up to date
• Current procedures being used to meet both QMS and MDR/IVDR regulations must be documented and include with descriptions of each.

Come 2020, the three-year transition period will come to an end, and after May 26, 2020, all new QMS regulations must be implemented by manufacturers for each device which they plan to sell in the European Union marketplace.

Conclusion

The European MDR is a taste of how the regulatory environment for medical devices will change during the coming decade. For example, ISO 13485 and the MDSAP program are already pushing for greater standardization and stronger post-market surveillance requirements, process-oriented risk management, and a life cycle-focused approach to device management.

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

Discuss

About The Author

Jon Speer’s picture

Jon Speer

Jon Speer is the founder and VP of QA/RA at Greenlight Guru, a software company that produces the only medical device quality management software (MD QMS) solution. Device makers in hundreds of cities in more than 50 countries use Greenlight Guru to get safer products to market faster and keep them there while pushing beyond compliance to True Quality.

Jon is a medical device industry veteran with over 20 years experience having helped dozens of devices get to market over his career in a variety of roles including product development, project management, quality and regulatory. He is a thought leader, speaker and regular contributor at numerous leading industry publications. He is also the host of the #1 most downloaded podcast in the industry, The Global Medical Device Podcast.

Comments

Botox is a drug not a medical device

You state Botox as an example of a medical device, Botox is a drug and is not a dermal filler.  It has a pharmacological effect of muscle, not filling facial wrinkles.  An example of facial fillers would be Radiesse (brand name).

Thanks for heads-up

You are correct. Thanks for bringing that to our attention. We have removed that reference.