In the context of the EU medical device regulation (EU MDR), what is an “economic operator” and why is it important for medical device manufacturers to understand the roles of economic operators? What is the difference between “placing on the market” and “making available on the market,” and why is that important?

The term “economic operators” is defined in EU MDR 2017/745 as “a manufacturer, an authorized representative, an importer, a distributor or a person” that is part of the product supply chain. This includes, for example, manufacturers, importers, distributors, and warehousing facilities. The regulation describes the responsibilities of the many integral entities to bring a medical device to market in a compliant manner as well as their responsibilities once the device is on the market.

Answers to the following questions can help clarify the various roles and responsibilities of the economic operators:

  • How do these economic operators need to interact with a European Commission (EC) representative, competent authorities, and notified bodies, according to the EU MDR?
  • What is the impact if the manufacturer resides inside or outside the European Union?
  • What are the requirements for importers and distributors?
  • Can an importer and a distributor be the same entity for a given medical device?

[Related: Check out our latest FREE report that includes a look at how the EU MDR will impact combination products. Click here to access it.]

At the virtual  RAPS Euro Convergence Conference in May, two speakers discussed Economic Operators in light of the then-upcoming date of application for EU MDR on May 26. The speakers on the topic were:

  • Medical Device Safety Service (MDSS) GmbH President Ludger J. Moeller (Authorized Representative, or AR)
  • NAMSA Medical Writer Richard Bassett (Contract Research Organization, or CRO)

The speakers provided varied perspectives from an AR, CRO, and notified body toward addressing the requirements for economic operators. 

Authorized Representative Perspective

Moeller debunked myths about economic operators. He began by clarifying the definition of a “manufacturer” as it relates inside and outside the European Union.

As shown in Figure 1, the key criteria to establish the entity that is the manufacturer is the one who fulfills the definition of “placing on the market.” “Placing on the market” according to EU MDR means the first making available of a device, other than an investigational device, on the EU market.

Figure 1 Manufacturers Inside and Outside the European Union
FIGURE 1 | Manufacturers Inside and Outside European Union

A manufacturer outside of the European Union would not be the manufacturer as it is not that particular company placing the device on the market, but, rather, the importer in the European Union that meets this criterion.

He indicated from his discussions with insurance companies in his role as an AR that “insurance companies view the importer as being very critical because according to the European regulation on liability the importer is actually the one that is liable.” Moeller further stated that “the liability regulation in the European Union has not changed as a result of EU MDR.” Conversely, a manufacturer existing in the European Union would fulfill the criterion of “placing on the market.” 

Can an importer and a distributor be the same entity? Moeller’s answer is “no.” He made a clear distinction between an importer and distributor as noted in EU MDR. A distributor is any natural or legal person in the supply chain, other than the manufacturer or importer, that makes a device available on the market, up until the point of putting it into service. The basic difference in the roles is between “placing on the market” (importer) and “making available on the market” (distributor). To be clear, however, an importer could distribute product to an end user. 

In Figure 2, there is a reference to Article 10 of EU MDR—General obligation of the Manufacturer— and Annex III. Both stipulate the communication expectation of the manufacturer with the economic operators from a quality management system (QMS) and post-market surveillance perspective, respectively.

Figure 2 Manufacturer Requirements
FIGURE 2 | Manufacturer Requirements

Moeller indicated that “it may make sense” to establish contract agreements among economic operators, such as between Manufacturer-Importer, Manufacturer-Distributor, or Importer-Distributor. But it is not a requirement of the EU MDR.

The important expectation is the communication of nonconformities or device-related issues among economic operators with notified bodies and competent authorities. A contract agreement is a legally binding arrangement between the entities involved. This would assist in formalizing the relationship among the economic operators. These contract agreements are subject to review by a regulatory authority.

Figure 3 outlines product flow for the following three areas:

  • Informing authorities on noncompliance issues
  • Informing authorities on serious risks due to a noncompliance issue
  • Informing authorities on vigilance interactions

Figure 3 also displays the necessary interactions for a company existing outside of the European Union to be notified of, as well as its communication pathways to the appropriate authorities within the European Union.

Figure 3 Post-Market Surveillance Roadmap
FIGURE 3 | Post-Market Surveillance Roadmap

Moeller stated that a manufacturer “may receive multiple communications of one product failure” given the requirements. He did explain that Figure 3 does not provide all the communication pathways that might need to be executed but rather, only the “most important ones.” 

The complexity of the necessary communications among economic operators is displayed in Figure 3. The interrelationship of the economic operators highlights the impact of EU MDR to generate awareness of non-compliant issues so the appropriate steps and corrective actions can be enacted.

[Related: Find out what two GMP experts think about the impact of the EU MDR on combination products. Click here to access a FREE report.]

Perspective on Impact to Manufacturer

Bassett described what the impact of MDR/IVDR requirements for economic operators means for manufacturers. He opened his presentation by explaining that manufacturers do not need to ensure the various economic operators are compliant with EU MDR (Figure 4). He stated that “this is not a compliance issue and you will not be checked as a part of your conformity assessment.”

Figure 4 Manufacturers Requirements
FIGURE 4| Manufacturers’ Requirements

While an importer or distributor would not be in scope for a conformity assessment audit, he said that what falls under the scope of an audit are “the requirements in regard to the procedures, policies, and contracts they have set up for themselves” as part of their QMS. As per ISO 13485, the entities that are a part of the distribution of a medical device could be subject to an audit. 

Bassett explained that a manufacturer may incorporate another manufacturer`s device, e.g., as part of a test kit or procedure pack. As a result, the manufacturer would be making the device available to the market (distributor role) or placing it on the market in the European Union (importer role). Figure 5 outlines some of the requirements if a manufacturer becomes an importer or distributor. As their role would be changing from a regulatory perspective, they would need to adhere to certain requirements as indicated by being a distributor or importer.

Figure 5 Distributor and Importer Requirements
FIGURE 5| Distributor and Importer Requirements

In summary, it is important to understand the relationship of economic operators with their role in moving devices through the supply chain. Requirements will change as a function of a company’s role in making devices available to the market. Understanding the reporting requirements for economic operators to the appropriate regulatory authorities will be paramount given the attention to post-market surveillance as described in EU MDR.

[Editor’s note: For more from Mark Agostino on the EU MDR, read his article, “Navigating a Regulatory Path to Market Through EU MDR Article 117.”]

[Related: Are you a combination products manufacturer? Read our latest FREE report that includes additional articles on the topic. Click here to access it.]

Combination Products Report ad

Changing Medical Device Regulations

Presented by Redica Systems 

What you will learn:

  • The latest developments regarding the EU MDR
  • Quality Systems requirements for medical devices
  • Regulatory updates affecting medical devices

Download the Special Report

Download your copy of THE FDA INSPECTION LANDSCAPE IN MID-2020 AND A LOOK AT VIRTUAL INSPECTION

In this summary we identify:

  • Trend analysis of FDA inspections through mid-2020
  • Strategies for preparing and hosting virtual inspections
  • New technologies to support remote inspections
Redica Systems Enforcement Analytics

Compare the enforcement history of your CDMOs.

Enter your email address and someone will contact you shortly to customize your report.

Redica Systems Enforcement Analytics

Monitor compliance at your Clinical Investigator sites.

Enter your email address and someone will contact you shortly to get you started.

Redica Systems Enforcement Analytics

Prepare for inspections of Clinical Investigator sites.

Enter your email address and someone will contact you shortly to provide more Clinical Investigator data about your sites.

Redica Systems Enforcement Analytics

Prepare for your next inspection.

Enter your email address and someone will contact you shortly to explore enforcement trends. 

Redica Systems Enforcement Analytics

Prepare for your next inspection.

Enter your email address and someone will contact you shortly to explore observations and trends. 

Redica Systems Enforcement Analytics

Prepare for your next inspection.

Enter your email address and someone will contact you shortly to run your custom report.

Redica Systems Enforcement Analytics

Get help choosing the right CRO.

Enter your email address and someone will contact you shortly to customize your insights.

Redica Systems Enforcement Analytics

Compare two companies of your choice.

Enter your email address and someone will contact you shortly to customize your report.

Download the Special Report

CDMO Comparison opt-in

In this summary we identify:

FY2018-FY2020 GMP data for Lonza & Catalent

Top GMP primary citations

Top FDA 483 observations

Redica Systems Enforcement Analytics

Evaluate Your CDMOs

Enter your email address and someone will contact you shortly to customize your report.

Panel Discussion – Remote Audits

Panel Discussion opt in image

Featuring Panelists:
—Barbara W. Unger, Unger Consulting, Inc.
—Jerry Chapman, Redica Systems
—Stephanie Gaulding, Pharmatech Associates

Who Will Benefit?
This session will be valuable to GMP quality, regulatory, compliance, and management personnel in FDA-regulated industries who want to have a conversation on remote audits and get to know what is going on in the industry.

Turning Failure into Success

Presented on Tuesday, April 27, 2021 by Steve Greer, Executive Coach, Genesis Assist, and former Quality Leader, Procter and Gamble

What you will learn:

  • How to use the Leadership SOS Model to transform quality culture
  • How to strengthen quality systems to eliminate human error
  • How to generate ideas on how to set your organization up for success for shareholders, FDA, and staff
Redica Systems Enforcement Analytics

Get Full Access to Redica Enforcement Analytics

Enter your email address and someone will contact you shortly to answer all of your questions and get you started.

Quality Management Systems for Small Pharma and Biotech Firms

Webinar: QMS for Small Pharma and Biotech Firms

Presented by Fenton Fong, Founder, Managing Director, & Principal at xCellarate

Get instant access to the webinar video and slides.

What you will learn:

  • Common challenges small pharma firms face when developing a QMS
    Recent enforcement trends involving the Quality Unit
    Impact of the COVID-19 pandemic

Download the Special Report

APAC ad

In this summary we identify:

GMP data from FY2017 to FY2020 for the Asia-Pacific region

Top 3 GMP primary and secondary citations

Top 3 483 observations

Download the Special Report

An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

In this summary we identify:

  • Data from 2019 UK MHRA Inspections
  • Trends from 2015, 2016, 2018, and 2019 inspections
  • Conclusions drawn from an analysis of drug inspection data

Experience the Power of Redica Systems

Redica_Vert_Periwinkle_RGB_Large

SEARCH Find the inspection records you want by inspector’s name, company name, site, city, country, etc.

WARNING LETTERS Easily search the largest database of FDA Warning Letters by date, company, FDA office, or subject

SITES Quickly assess inspection records including dates and inspectors across all of your sites

INSPECTIONS Complete list of FDA inspections by date, company, category, and country

Get Complete Access to the Redica Systems Platform

Please submit your email address and one of our team members will contact you shortly to answer all of your questions and get you started with the new Enforcement Analytics platform.

Redica Systems Enforcement Analytics

Compare the inspection history of your CDMO sites.

Enter your email address and someone will contact you shortly to customize your report.

Experience the Power of Redica Systems

Complete the form and one of our experts will reach out to you to schedule a demo and answer questions about our subscription options.

INDEX INFORMATION  Redica consolidates regulatory data in real-time on the single largest database for quality, safety, and compliance intelligence.

STRENGTHEN DATASETS Redica machine intelligence algorithms identify and triage risk signals to derive meaning from vast amounts of private and public data.

ANALYZE & INTERPRET PATTERNS Redica instantly models the customer-specific regulatory risks, trends, and opportunities that stand to fundamentally change compliance operations.

Download the Special Report

Combination Product Report

What You Will Learn from This Report:

The latest U.S. and European regulatory developments

The impact of smart combination products

How the EU MDR impacts drug-device combination products

Experience the Power of Redica Systems

Redica Systems Enforcement Analytics

Let us know who you are and we’ll be in touch to answer all of your questions and get you started.

Download the Special Report

5 GMP Case Studies Report

What You Will Learn from This Report:

In-depth analysis of the findings

Lessons learned

How companies can avoid similar shortcomings.

Experience the Power of Redica Systems

Redica Systems Expert Jerry Chapman to Present at SQA Annual Meeting

Index Information Redica consolidates regulatory data in real-time on the single largest database for quality, safety, and compliance intelligence.

Strengthen Datasets Redica machine intelligence algorithms identify and triage risk signals to derive meaning from vast amounts of private and public data.

Analyze & Interpret Patterns Redica instantly models the customer-specific regulatory risks, trends, and opportunities that stand to fundamentally change compliance operations.

Download the 510(k) Sample

What You Will Learn from This Sample:

See how a 510(k) submission is structured

Find out what information to include

Review correspondence between sponsor and FDA

Redica Systems Enforcement Analytics

Unlimited Access to Reports and Data

Enter your email address and someone will contact you shortly.

Download the Special Report

5 GMP Case Studies Report

What You Will Learn from This Report:

The first countrywide import alert issued by FDA

An inadequate deviation investigation

An inadequate product specifications and a product recall

Process validation issues at a CMO

A different perspective on process validation and the culpability of the quality unit

 

A.I. for Quality and Compliance Teams

August 3 webinar

Presented by Redica Systems Senior GMP Quality Expert Jerry Chapman

What you will learn:

  • A basic understanding of data sources, machine learning, NLP, and A.I. tools
  • Building and applying Expert Models
  • Two case studies, one on sterile manufacturing/503B and one on data integrity

Get the scoop on recent data integrity 483 observations!

  • FY 2020 Data Integrity 483 Observations
  • Data Integrity Observations for Human Drugs
  • Observations Falling Under GMP
  •  

Human Factors – Compliance and Applications

June webinar

Presented by Alison Sathe, Founder, Regulatory Mark & Valerie Fenster, Director of Insights and  Human Factors, Kaleidoscope Innovation 

What you will learn:

  • Human factors strategies from simple drug products to complex surgical devices
  • Primary and secondary labeling development and evaluation for usability
  • Human factors activities from product development to post-market
  • International strategies: expectations for human factors in regulatory submissions in international markets
Redica Systems Enforcement Analytics

Keep up with the latest Regulatory Developments on Clinical Trials

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Upgrade your inspection strategy.

Enter your email address and someone will contact you shortly to get the reports and analysis you need to prepare for your next inspection.

Redica Systems Enforcement Analytics

Save your team valuable time when using External Monitoring.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Save time and Resources when using External Monitoring.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Get immediate access to the news that matters to your sites.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

See how we can help you eliminate yet another spreadsheet.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Stay ahead of changing regulations.

Enter your email address and someone will contact you shortly to get the data and analysis you need.

Redica Systems Enforcement Analytics

Upgrade your CDMO monitoring strategy.

Enter your email address and someone will contact you shortly to get the data and analysis you need.

Redica Systems Enforcement Analytics

Upgrade your CDMO management strategy.

Enter your email address and someone will contact you shortly to get the reports and analysis you need.

Experience the Power of Redica Systems

Redica Systems Enforcement Analytics

Sign up for your FREE account today and get instant access to Enforcement Analytics.

Redica Systems Enforcement Analytics

Upgrade your inspection strategy.

Enter your email address and someone will contact you shortly to get the reports and analysis you need.

Discover the power of the most comprehensive database of 483s in existence.

Our database of over 20,000 483s is retyped and tagged, making it easy to create an Observation Report in seconds.

Eliminate days of work and get your FREE personalized 483 Observation Report.