The European Union’s (EU) Medical Device Regulation (MDR), officially passed in April of 2017, may cause significant changes to the regulatory obligations of legal manufacturers, importers and distributors involved in the medical device distribution chain.
The new MDR regulations differ significantly from the current EU Medical Device Directive (MDD) and go beyond design, development and manufacturing requirements. Specifically, these new requirements are related to post-market importation and distribution activities of medical devices in the European Economic Area (EEA).
Importers and distributors are currently subject to fragmented national law obligations and responsibilities. Replacing the current council directive 93/42/MDD, as amended within the European Regulation on Medical Devices EU-MDR/2017/745, will require that all economic operators in the medical device distribution chain be subject to the same rules throughout Europe.
These rules originate from the EU’s New Legislative Framework for the Marketing of Products (also known as the Goods Package), consisting of Regulation No. 765/2008 on Market Surveillance and Decision No. 768/2008 on the Marketing of Products. This regulation outlines a common framework of general principles which reference provisions for the creation of community legislation harmonizing the conditions of product marketing.
The below blog post provides an overview of changes to be presented by the EU MDR for medical device manufacturers, importers and distributors – collectively defined as economic operators – and how these new obligations may impact current supply and distribution agreements.
New Under the EU MDR
An important focal point related to the new distribution chain for medical device manufacturers surrounds a system of checks and balances. Each economic operator must verify that a previous economic operator has complied with the EU MDR requirements. Thus, importers and distributors must ensure independently that, prior to placing a medical device on the market, the manufacturer, importer and the device itself meet the stipulated EU MDR regulatory requirements.
Article 13: General Obligations of Importers
1) In order to place a device on the market, importers shall verify that:
- the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
- a manufacturer is identified and that an authorized representative, in accordance with Article 11, has been designated by the manufacturer;
- the device is labelled in accordance with this Regulation and accompanied by the required instructions for use; and
- where applicable, confirm that a unique device identifier (UDI) has been assigned by the manufacturer in accordance with Article 27.
2) Where an importer considers, or has reason to believe, that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer’s authorized representative.
3) Where the importer considers, or has reason to believe, that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established.
4) Importers shall indicate on the device, its packaging, or in a document accompanying the device, their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.
5) Importers shall verify that the device is registered in the electronic system in accordance with Article 29. Importers shall add their details to the registration in accordance with Article 31.
6) Importers shall ensure that, while a device is under their responsibility, storage or transport that conditions do not jeopardize its compliance with the general safety and performance requirements set out in Annex I and shall comply with the conditions set by the manufacturer, where available.
7) Importers shall keep a register of complaints of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorized representative and distributors with any information requested of them in order to allow them to investigate complaints.
8) Importers who consider, or have reason to believe, that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and its authorized representative.
9) Importers shall co-operate with the manufacturer, the manufacturer’s authorized representative and the competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or recall is taken.
10) Where the device presents a serious risk, importers shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the Notified Body that issued a certificate in accordance with Article 56 for the device in question giving details in particular of the non-compliance and of any corrective action taken.
11) Importers who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market shall immediately forward this information to the manufacturer and its authorized representative.
12) Importers shall, for the period referred to in [MDR] Article 10(8), keep a copy of the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements issued in accordance with Article 56.
13) Importers shall cooperate with competent authorities at the latter’s request on any action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market.
14) Importers, upon request by a competent authority of the Member State in which the importer has its registered place of business, shall provide samples of the device free of charge or, where that is impractical, grant access to the device.
The above mandatory importer obligations will no doubt have far-reaching implications. For example, the importer will have to carefully evaluate and verify whether the legal manufacturer located outside the EU has the technical, scientific and financial capacity to manufacture a medical device that is compliant with the current EU MDR.
Additionally, the importer has a legally binding obligation to take its own corrective action when necessary and engage in post-market surveillance activities, which means that the agreement between the legal manufacturer and the importer will need to address how this will be effectively implemented.
A downright challenging obligation relates to the fact that an importer must verify that the manufacturer has applied the “appropriate” conformity assessment procedure to the device, and that the product bears the “required” CE marking of conformity. This means that the importer cannot simply rely on a warranty with indemnity by the manufacturer in regards to compliance, but will need to actively assess the legal manufacturer and establish their own judgment regarding the compliance of the manufacturer and be willing to refuse to import a non-compliant device.
Article 14: General Obligations of Distributors
1) Before making a device available on the market, distributors must verify that all of the following requirements are met:
- the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
- the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11); and
- for imported devices, the importer has complied with the requirements set out in Article 13(3) that where applicable, a UDI has been assigned by the manufacturer.
- In order to meet the requirements referred to in points (a), (b) and (d) of the above, the distributor may apply a sampling method that is representative of the devices supplied by a distributor.
2) Where a distributor considers, or has reason to believe, that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer’s authorized representative and the importer. Where the distributor considers, or has reason to believe, that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established.
3) Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer and must engage in post-market surveillance (i.e., report complaints).
4) Distributors that consider, or have reason to believe, that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, the manufacturer’s authorized representative and the importer. Distributors shall co-operate with the manufacturer and, where applicable, the manufacturer’s authorized representative and the importer, and with competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it as appropriate, is taken. Where the distributor considers, or has reason to believe, that the device presents a serious risk, it shall also immediately inform the competent authorities of the Member States in which it made the device available, giving details of the noncompliance and of any corrective action taken.
5) Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available shall immediately forward this information to the manufacturer and, where applicable, the manufacturer’s authorized representative and the importer. They shall keep a register of complaints of non-conforming devices and of recalls and withdrawals, and keep the manufacturer and, where available, the authorized representative and the importer informed of such monitoring and provide them with any information upon their request.
6) Distributors shall, upon request by a competent authority, provide them with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device.
7) Distributors shall be considered to have fulfilled the obligation referred to in the first subparagraph when the manufacturer or, where applicable, the authorized representative for the device in question provides the required information. Distributors shall cooperate with competent authorities at their request on any action taken to eliminate the risks posed by devices which they have made available on the market. Distributors, upon request by a competent authority, shall provide free samples of the device or where that is impracticable, grant access to the device.
Consequently, the distributor also accepts significant additional regulatory burden and risks with the mandatory requirements to verify that: (1) the product bears the required CE marking of conformity, and (2) the manufacturer and the importer (where applicable) have complied with EU MDR requirements in Article 13.
Similar to an importer, the distributor must demonstrate to the competent authorities that it has actively verified these requirements and that it is not relying on the other party’s commitments and declarations.
The distributor’s and importer’s legal responsibilities for storage and transport raise an interesting new question of the definition of “while a device is under its responsibility.”
When is a device “under the responsibility” of the distributor or importer? If this refers to a contractual responsibility, distributors and importers will have a strong incentive to limit the duration that they are responsible for a device or try to push out this responsibility as much as possible.
Another issue relates to the transport and the question of whether this includes both transport to and from the importer’s or distributor’s warehouses? And, what if the importer or distributor does not have a controlled warehouse, but has products delivered directly from the factory to the manufacturer?
This provision is likely to cause a lot of confusion until the legal concept of “responsibility” is interpreted by the European Court of Justice.
Significant Changes to Safeguard and Market Surveillance Obligations
Important changes have also been implemented with respect to safeguard and market surveillance obligations. It is apparent that these proposed changes are effected by the provisions of the Decision on the Marketing of Products1.
Under the MDD, it is the responsibility of Member States’ competent authorities and legal manufacturers to take safeguard and corrective measures against medical devices posing a risk to public health.
Under the EU MDR, this responsibility has expanded to include importers and distributors. Thus, importers and distributors will be obligated to take all the necessary measures to prevent a medical device from being placed on the EU market, or even withdraw or recall it, should they have credible evidence that it does not comply with the requirements set forth in the EU MDR.
Should a device present unreasonable risk to the end users, importers and distributors should immediately notify the competent authority of the respective Member State and the Notified Body.
Additionally, importers and distributors should immediately forward to the manufacturer, or the authorized representative, complaints or reports from end users about suspected incidents with the relevant device.
For devices with higher risk profiles, manufacturers may need to carry out sample testing of marketed products, investigate complaints and keep a complaint log of nonconforming products and of product recalls and withdrawals. Manufacturers, authorized representatives and distributors must be kept informed of such events.
These new changes should be carefully taken into consideration when revising current supply and distribution agreements in compliance with the EU MDR and all parties of the agreement should enter into these new obligations with a full understanding of all responsibilities. Due to the importance of EU MDR requirements, obligations should be fulfilled with no delay in order to prevent any individual liability issues.
Forward traceability of a medical device, other than custom made or investigational devices, throughout the distribution chain is another crucial feature of the EU MDR as all economic operators will have to track devices.
Manufacturers, importers and distributors will have to identify at any given time from whom – and to whom – among the supply chain when the medical device was supplied, including devices provided to health institutions and/or healthcare professionals.
The obligation of downstream traceability among economic operators is closely connected to the MDR’s safeguard measures. It will enable economic operators and the Member States’ competent authorities to accurately allocate problematic devices in the case of recalls and market withdrawals, as well assist with field safety notices.
Finally, the EU MDR introduces other new and important requirements such as:
- an importer is responsible to register an imported device in the electronic database system on the registration of devices and economic operators (which will reside in the Eudamed database); and
- a manufacturer of an implantable device must issue a patient implant card which shall be made available to the healthcare professional implanting the device.
All said, the legal manufacture of implantable devices must ensure that all downstream economic operators are obliged to associate the device with the patient implant card, and that the last known distributor can make the implant card available to a healthcare professional at any given time.
These new EU MDR importation and distribution requirements for medical devices expand regulatory due diligence from legal manufacturer to importers and distributors. Each economic operator must verify regulatory compliance independently and generate its own records of compliance and be aware that they may be subject to unannounced audits. More important than ever, economic operators must confirm compliance with all partners – including agreement validity – to avoid serious regulatory compliance issues and increased enforcement action from EU authorities.
Many of the new regulatory compliance responsibilities for importers and distributors set forth in MDR/2017/745 will need to be agreed upon and further specified in legally binding distribution and supply agreements. Not only must new agreements comply with these provisions, but current distribution agreements may have to be revised accordingly if their duration extends beyond the EU MDR enforcement date.
Importers and distributors will have a regulatory mandate to verify and monitor regulatory compliance throughout the product lifecycle. Some of these new requirements will likely require implementing a Quality Management System (QMS) to suitably and effectively fulfill these new obligations. It should be noted that the newly released ISO 13485:2016 Quality Management Standard already makes reference to these post-approval import and distribution requirements.
It is critical that each contracting party ensures implementation and compliance when entering or updating distribution agreements. The EU regulatory authorities can – and likely will – enforce punishment against nonconforming economic operators for identified serious noncompliance.
Finally, it is important to note that distribution and supply agreements only establish formal compliance. In practice, economic operators must consider ways to share and maintain pertinent regulatory compliance information so that action taken by any given economic operator does not prejudice the interests or compliance of other upstream or downstream partners.
Do You Have an EU MDR Compliance Plan in Place?
NAMSA’s global regulatory experts welcome the opportunity to discuss strategic options related to the new EU MDR regulations, including the potential business impacts for distributors and importers of medical devices in the EU. How can you plan for success? Contact us at email@example.com, or visit our regulatory consulting webpage here, to learn how we are assisting countless medical device organizations succeed under the latest regulatory EU landscape.
Stephan Buttron currently serves as NAMSA’s Senior Product Development Strategist. Mr. Buttron has over 20 years’ experience in achieving EU, U.S. FDA and other international regulatory medical device approvals and registrations. He has provided global consulting services on regulatory strategy development to medical device manufacturers regarding least burdensome pathways for 510(k)/PMA and MMD-CE mark applications. He has successfully managed FDA pre-submission meetings for Investigational Device Exemption (IDE) pathways with multiple FDA specialty branches. Stephan is considered a key industry thought leader on risk management, and has provided multiple training sessions to medical device manufacturers on structured risk management process per EN ISO 14971 & EU MDD 93/42 as amended with directive 2007/ 47. Mr. Buttron has also provided countless educational opportunities to international organizations regarding medical device design and development issues related to ISO 13485 & EU MDD 2007/47 compliance.