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Regulatory Focus™ > News Articles > 2020 > 2 > Economic Operators: Roles and Obligations Under EU’s MDR

Economic Operators: Roles and Obligations Under EU’s MDR

Posted 04 February 2020 | By Randolph Fillmore 

Economic Operators: Roles and Obligations Under EU’s MDR

Regulatory and legal experts share their views on the European Union’s revised Medical Device Regulation (MDR) and the EU’s requirements for Economic Operators (EOs) to play major roles in medical device authorizations and postauthorization monitoring. The article also highlights roles and responsibilities for Manufacturers, Authorized Representatives, Importers and Distributors (MAID) for assuring compliance with new EU MDR in addition to public health/patient safety goals. The article was developed in cooperation with Ludger Möller and Erik Vollebregt who will be presenting this topic at RAPS Euro Convergence, 11-13 May 2020 in Brussels, Belgium.
 
Introduction
 
The EU Medical Devices Regulation (MDR)1 and In Vitro Diagnostic Medical Devices Regulation (IVDR)2 introduce a complete economic operator regime for medical devices. After being approved by the European Council and the European Parliament, in May 2017, the European Medical Devices Regulation (MDR) came into force. MDR implementation is set for May 2020.3 While the new regulations aim at enhancing medical device safety and effectiveness, their genesis is the result of several years of new developments, both scientific and technical, in addition to the perceived need to redesign the EU regulatory landscape to improve quality and safety and alignment of medical devices regulation with EU goods regulation for other CE marked goods set out in the 2008 template New Legislative Framework for the Marketing of Products (see recitals 25-27 MDR). Since 2008, the EU has gradually implemented the economic operator requirements in every CE marking directive and regulation that was renewed. Through MDR, new roles and responsibilities have appeared up and down the medical device supply line with the requirement that Manufacturers, Authorized Representatives, Importers and Distributors (MAID) function as Economic Operators (EOs) with distinct and sometimes overlapping roles and responsibilities. In short, under the EO mandate, quality and regulatory compliance responsibilities have risen to new heights and are much broader than with the older regulations.
 
Which MAID EO is responsible for what?
 
  • Manufacturers: responsible for Eudamed registration, technical documentation, design, development manufacture and assembly, handling, storage and distribution, corrective actions, UDI labeling, complaints, postmarket surveillance and the PRRC.
  • Authorized Representatives: responsible for Eudamed registration, technical documentation, corrective actions, UDI labeling, postmarket surveillance and PRRC.
  • Importers: responsible for Eudamed registration, handling, storage and distribution, corrective actions, UDI labeling, postmarket surveillance.
  • Distributors: responsible for handling, storage and distribution, corrective actions, UDI labeling, complaints and postmarket surveillance.
 
Learning to Play by the Rules
 
While the EO emphasis in MDR means that there many and varied new rules, how can supply chain players adhere to the rules and determine their obligational roles for doing so? According to Erik Vollebregt:
 
 “They can determine this by understanding their role in the supply chain and by understanding the rules, which requires understanding of the concept of ‘placing on the market for the importer and ‘making available for the distributor.”
 
For Vollebregt, ‘placing on the market’ means the first making available of a device other than an investigational device. He emphasizes the operation of ‘placing on the market’ is reserved for, and can only be done by, a manufacturer or an importer. He adds that the placing on the market is “the most decisive point in time” in the new legislative framework4 and that “there is a widespread misunderstanding that companies can ‘appoint’ economic operators like importers and distributors, but this is not how the MDR works. The MDR uses a definition for each economic operator, which means that the facts of the economic operator’s situation either fit the definition or not. So companies should not rely on contracts to appoint an economic operator, but rather analyze if the relationship agreed under the contract fits the MDR’s definitions or not.”
 
Ludger Möller clarifies further that the placing on the market refers to the placing on the market of each individual single product. Sometimes it is mistaken that this refers to a group of products and once a product is placed on the market “for the first time” that then subsequent products can be further placed on the market. This is a misconception since there is no first placing on the market! Should a requirement change the very next product may then have to be updated before it is being placed on the market.
 
Eudamed Registration, PRRCs and Their Responsibilities
 
According to Vollebregt, MDR requires manufacturers, authorized representatives and importers to register in Eudamed, the EU’s electronic database. “The idea was that Eudamed would allow complete transparency of the supply chain, but now that Eudamed has been delayed, we will have to see how the existing national mechanisms that should be used until Eudamed is up will work for the EOs.”
 
Möller outlines that a recent MDCG guidance clarifies that the PRRC of the manufacturer and of authorized representative cannot be the same person. Besides the reason given in the MDCG guidance the responsibilities of the manufacturer’s PRRC for the conformity assessment procedures are specifically excluded from the mandate a manufacturer may give to the authorized representative. This would open doors for a conflict of the interest in creating its own records. How can someone verify that a technical documentation has been drawn up and at the same time being responsible for it.
 
Overlapping EO Obligations and Sharing Resources
 
According to Vollebregt, the EO function does not translate well to large companies when multiple EOs are under the same joint control. This reality, he says, makes amending supply chain contracts a good idea. Can a company pool resource between various EOS? Yes, says Vollebregt.
 
Vollebregt also notes that EOs among the MAID players along the chain have “overlapping” obligations; but that the number and scope of obligations reduces going down the supply chain after starting with manufacturers and authorized representatives as the most obligated and importers and distributors less so. Understanding which EO obligation is whose obligation may be key to quality control. This obligation identification requires what Vollebregt calls “awareness and awakeness” on the part of the MAID players.” They also suggest that efficiency-driven companies will strive to find the most efficient ways of achieving what regulators expect from them.
 
 “Accordingly, there is a shared interest among EOs to cooperate more intensively, including sharing resources to avoid duplicating work,” said Vollebregt.
 
Some observers may be concerned about a business/regulatory model that may, inadvertently, include either EO work duplication or that the EO function and quality may be undermined by some EOs in the MAID supply chain taking for granted that “someone else has already done that or will do that.”

Regardless, spreading compliance responsibility among all MAID players appears to have been an EU objective from the start.
 
EO Roles
 
Manufacturers and ARs appear to be most directly affected in terms of EO responsibilities. According to Vollebregt, there are “big changes” in store for ARs, those both inhouse and external. Too, there are now prescriptive rules for an AR mandate and contract. “As with notified bodies, ARs are now recruited into market surveillance,” said Vollebregt in a recent presentation. “ARs must provide information, cooperate in investigations and verify that appropriate conformity assessment procedure has been carried out by the manufacturer. The AR must have a PRRC.” He added: “I expect the requirement for ARs to terminate the mandate and report the manufacturer to the authorities and notified body to lead to a lot of friction and conflict. Historically, many manufacturers see the AR as a communication channel with authorities but certainly not as a party that has anything to say about the manufacturer’s compliance.”
 
According to Möller, the authorized representative now have been called the “little notified body” and indeed remembering the introduction of the MDD in 1998 some notified bodies indeed only verified at that time that the technical documentation was drawn up. A clear requirement of the authorized representative today. In addition, the authorized representative has the power to stop the European business quickly with terminating the mandate. This is an interesting requirement in a cooperate setting. For example, this applies as well for a subsidiary and that subsidiary would have to terminate the mandate with the mother company.
 
The PRRC
 
The Person Responsible for Regulatory Compliance (PRRC) is a vital part of the EO function. Vollebregt outlines the PRRC requirements by reference to MDR Article 15,5 which says a manufacturer must employ a PRRC and that the PRRC role may be shared between several persons. He also notes the PRRC for the manufacturer and the AR cannot be the same person and that the PRRC for the AR must be located within the EU and that PRRC qualifications must be proven by demonstrated member state equivalency.
 
Who can be a PRRC? According to Vollebregt a PRRC:6,7
 
  • is qualified through education or experience
  • has a university degree or study recognized equivalent by a member state
  • has a degree in law, medicine, pharmacy, engineering or other relevant discipline
  • has more than one year of experience in medical devices in regulatory affairs or quality management systems
  • has four years of experience in medical devices (for MDR) or IVDs
 
Vollebregt lays out the responsibilities of the PRRC as follows:
 
  • assuring the conformity of the devices is appropriately checked in accordance with the Quality Management System (QMS) under which the devices are manufactured before a device is released onto the market
  • assuring the technical documentation and the EU declaration of conformity are drawn up and kept up to date.
  • assuring the postmarket surveillance obligations are complied with in accordance with Article 10 (10) MDR/10 (9) IVDR
  • assuring the reporting obligations referred to in Articles 87 to 91 MDR/82 to 86 IVDR are fulfilled
  • assuring in the case of investigational devices the statement referred to in Section 4.1 of Chapter II of Annex XV MDR/XIV IVDR is issued
 
Authorized Representative and Non-EU Manufacturer Liabilities
 
Regarding manufacturers who are not established in the EU:
 
(35) For manufacturers who are not established in the Union, the authorised representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union. Given that pivotal role, for the purposes of enforcement it is appropriate to make the authorised representative legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general obligations. The liability of the authorised representative provided for in this regulation is without prejudice to the provisions of Directive 85/374/EEC, and accordingly the authorised representative should be jointly and severally liable with the importer and the manufacturer.8
 
Möller outlines that he was surprised of the lack of understanding among importers in terms of their existing liability obligations even though the directive on liability is quite clear on this aspect. The above paragraph indeed mentions the importer but it does not so under the respective article 13. The MDR indeed adds confusion to the liability regime since the requirements are clearly outlined in the Directive 85/374/EEC. This is also most likely the reason that importers are obligated to add their name and information where they can be contacted with the product. It is interesting to observe that the liability concern is now a concern of the regulatory department with the focus on the patient. It was previously only in the financial department and the task was to protect the company. It does not matter, the result is the same.
 
Manufacturers
 
Regarding manufacturers’ liabilities:
 
(74) Manufacturers should play an active role during the postmarket phase by systematically and actively gathering information from postmarket experience with their devices in order to update their technical documentation and cooperate with the national competent authorities in charge of vigilance and market surveillance activities. To this end, manufacturers should establish a comprehensive postmarket surveillance system, set up under their quality management system and based on a postmarket surveillance plan. Relevant data and information gathered through postmarket surveillance, as well as lessons learned from any implemented preventive and/or corrective actions, should be used to update any relevant part of technical documentation, such as those relating to risk assessment and clinical evaluation, and should also serve the purpose of transparency.9
 
According to Möller, president of the Medical Device Safety Service, the new rules under MDR will render the medical device business to be “business NOT as usual.” He suggests that the overlapping EO roles and obligations among MAID players may work against “business as usual” because importers and distributors have, historically, not been in the verification “business.”
 
“The previous set of regulations did not change the nature of business; the new regulations already have,” says Möller.10
 
He also recognizes the many “gray areas” in MDR needing to be made “black and white” and looks for clarification for new regulations. He poses a host of MAID questions for which companies need answers.
 
Among those questions are:
 
  1. Can I consider myself a distributor?
  2. As a manufacturer, do I need to control my importer?
  3. As an importer, do I like to be controlled by my supplier?
  4. Can I have my subsidiary act as an importer?
  5. Do I want to take on the role of the AR?
 
The question will be addressed during the RAPS Euro Convergence, 11-13 May 2020 in Brussels, Belgium and proposals for solutions are going to be provided.
 
To many of these unanswered questions, the “gray answers” may be both “yes” and “no.” For example, regarding question number 2 above, Möller says this question touches on a “fundamental shift in regulatory thinking. The regulatory department of the manufacturer likes to control that requirements are indeed implemented and some indeed start to believe that the importer should be controlled with their supplier evaluation program. This may be possible if the manufacturer has a strong product, but it should not be forgotten that the importer in the first place is the customer for most of the manufacturer. The sales and marketing department may not agree with the activities of the regulatory department.
 
Möller has more questions:
 
  • How (exactly) does a distributor check on the importer and manufacturer?
  • How (exactly) does the importer check on the manufacturer and the authorized representative?
  • How (exactly) does the authorized representative check on the manufacturer and importer?
 
Vollebregt offers that these “how” questions reflect the need for relationships among MAID players that are “mutual and reciprocal” and points to the need to apply a “certain degree of quality control over each other.”
 
Conclusion
 
The experts each emphasize the need for clarification in certain areas of MDR’s elevation of the roles of EOs and offer some practical solutions for EOs to consider during the RAPS Euro Convergence. The CAMD and later the MDCG indicate that guidance is forthcoming. The experts also emphasize the need for all MAID players to hasten their efforts to comply with the looming May 2020 implementation.
 
“The Economic Operator (EO) regime under the MDR and IVDR is not new, it is based on the goods package as set out in Regulation 765/2008, which provided a template for regulation for CE-marked goods and established the ‘New Legislative Framework.’ MDR and IVDR strengthen and make more explicit the obligations of economic operators with substantial overlap and repetition.”11,12 Furthermore, the MDR has already been in force since May 2017.
 
These requirements have now found their way into the MDR with a focus on compliance via the extension of EO responsibilities and obligations to all MAID players—up and down the supply line—coupled with the parallel responsibilities of the PRRC.
 
References
 
  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. 5 May 2017.https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745. Accessed 28 January 2020.
  2. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. http://www.ce-mark.com/IVD%20Regulation.pdf. Accessed 28 January 2020.
  3. European Union Medical Device Regulation (EU MDR) 2017/645. Timelines. http://eumdr.com/timelines/. Accessed 28 January 2020.
  4. Szoboszlai A and Vollebregt E. “Implementation of Shared MDR Economic Operator Resources.” Regulatory Focus. September 2019. Regulatory Affairs Professionals Society. https://www.raps.org/news-and-articles/news-articles/2019/10/implementation-of-shared-mdr-economic-operator-res. Accessed 28 January 2020.
  5. Op cit 1.
  6. Op cit 1.
  7. Op cit 2.
  8. Position of the Council at first reading with a view to the adoption of a Regulation of the European Parliament and of the Council on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. http://data.consilium.europa.eu/doc/document/ST-10728-2016-INIT/en/pdf. Accessed 28 January 2020.
  9. Ibid.
  10. Interview with Möller by R Fillmore. Conducted 24 January 2020.
  11. Op cit 4.
  12. Op cit 10.
 
About the Experts
 
Ludger Möller is president of Medical Device Safety Service GmbH. He can be contacted at l.moeller@mdssar.com.
 
Erik Vollebregt is a partner at Axon Lawyers. He can be contacted at erik.vollebregt@axonlawyers.com.
 
About the Author
 
Randolph Fillmore is a technical writer for Florida Science Communications Inc.
 
Cite as: Fillmore R. “Economic Operators: Roles and Obligations Under EU’s MDR.” Regulatory Focus. January 2020. Regulatory Affairs Professionals Society.
 
 
 
 
 

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