Guidesheet for Importers and Distributors
under Medical Devices Regulation (MDR) (EU 2017/745) & In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU 2017/746)MDR/IVDR Q&A
Introduction and Timeline of MDR/IVDR:
The MDR will replace the existing medical devices Directive 93/42/ EEC (MDD) and active implantable medical devices Directive 90/385/EEC (AIMDD). The MDR was published in May 2017, with the transition period end on 26 May 2021, the “Date of Application” (DoA) of the MDR.
To avoid market disruption and to allow a smooth transition from the Directives to the Regulations, several transitional provisions are in place (MDR Article 120). Some devices with certificates issued under the Directives may continue to be placed on the market until 26 May 2024, and made available for sale to end customers until 26 May 2025.
The IVDR will replace the existing in vitro diagnostic medical devices Directive (98/79/EC) (IVDD). The IVDR was published in May 2017, with the transition period end on 26 May 2022, the “Date of Application” (DoA) of the IVDR.
To avoid market disruption and to allow a smooth transition from the Directives to the Regulations, several transitional provisions are in place (IVDR Article 110). Some devices with certificates issued under the Directives may continue to be placed on the market until 26 May 2024, and made available for sale to end customers until 26 May 2025.
Main Change Points
Assessment: MDR/IVDR retain all the requirements of the Directives, while adding some new requirements of their own. Compared to the MDD/IVDD, MDR/IVDR emphasize a life-cycle approach to safety, backed up by clinical data or performance data.
Classification: MDR reclassifies certain devices and has a wider scope than the Directives. Eg, Mindray Defibrillator/Monitors with AED function are classified from IIb(MDD) to III(MDR) with more stringent clinical evidence and conformity assessment requirement. As for IVDR, a new rule-based classification system is introduced, ranging from class A for lowest risk to class D for highest risk. Class A in sterile condition and Class B/C/D devices require Notified Body involvement. It means that around 85% of IVD medical devices will require a notified body for conformity assessment, compared to 20% under IVDD. Eg, Mindray β2-Microglobulin Kit is classified from others (IVDD) only with self-issued declaration of conformity (DoC) to Class B(IVDR) with increased conformity assessment from notified body.
Economic Operator: MDR/IVDR add more control and monitoring requirements and clarify the obligations of manufacturers, authorized representatives, importers and distributors.
EUDAMED: MDR/IVDR increase transparency, requiring the publication of information on devices and on clinical or performance studies related to their conformity. The new European Database for Medical Devices – EUDAMED – will play a central role in making data available and increasing both the quantity and quality of data (MDR Article 33&IVDR Article 30).
UDI: MDR/IVDR add a completely new requirement as the system of Unique Device Identifiers (UDIs) (MDR Article 27&IVDR Article 24). This will enhance the identification and traceability of devices. The UDI will allow all stakeholders to access basic information on devices through EUDAMED.
Table 1 Responsibilities of Importer and Distributor
( “●” means finish the responsibility as remarked in“ Detailed content” )
|Verification||Verify CE marking/EU declaration of conformity/ EU authorized representative/Labelling/UDI||●||●|
|labelling||Attach the Importer label||●||Check|
|Save files||Keep a copy of EU declaration of conformity and relevant certificate||Keep for 10 years||Keep for 10 years|
|Eudamed||Register importer SRN and check device list of manufacturers||●||/|
|storage or transport conditions||Make the storage or transport comply with general safety and performance requirements||●||●|
|Provide sample||if demanded by competent authorities||●||●|
|Post-market||Keep a register of complaints/nonconforming devices/recalls/withdrawals, and report.||Inform manufacturer/ AR||Inform manufacturer/AR/ importer|
|If a serious risk, inform the competent authorities||●||●|
Roles and responsibilities of importers:
1. Importers shall verify that: (a) the device has been CE marked and that the EU declaration of conformity has been drawn up; (b) a manufacturer has designated an authorized representative; (c) the labelling conforms with MDR/IVDR; (d) where applicable, an UDI has been assigned.
2. Importers shall indicate on the device or on 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.
3. Importers shall verify that the device is registered in EUDAMED. Currently the EUDAMED system hasn’t been released fully functionally.
4. Importers shall ensure that, the storage or transport conditions of the devices do not jeopardize its compliance with the general safety and performance requirements.
5. 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 by them, in order to allow them to investigate complaints.
6. 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.
7. Importers shall, for the period referred to in Article 10(8) of MDR and Article 10(7) of IVDR, keep a copy of the EU DoC and, if applicable, a copy of any relevant certificate.
8. Importers shall cooperate with competent authorities, shall provide samples of the device free of charge once upon request.
Roles and responsibilities of distributors:
1.Distributors shall verify that: (a) the device has been CE marked and that the EU declaration of conformity has been drawn up; (b) the device is accompanied by the information to be supplied by the manufacturer; (c) for imported devices, the importer has complied with the requirements set out in Article 13(3); (d) that, where applicable, a UDI has been assigned by the manufacturer.
2. Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer.
3. 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.
4. Distributors shall, upon request by a competent authority, provide it with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device. Distributors, upon request by a competent authority, shall provide free samples of the device.
Currently EUDAMED only release the Actor registration module, upon which the manufacturer/authorized representative/ importer can register to apply for one SRN (Single Registration Number) by one actor role.
1. For Mindray, the EU authorized
representative’s information is as:
Company Name: Shanghai International Holding Corp. GmbH (Europe)
Company Address: Eiffestrasse 80, 20537 Hamburg
2. Mindray’s SRN as non-EU manufacturer are under review and will be obtained soon.
4. Currently the device registration module hasn’t been released. The European Commission concluded that its database of medical device information (Eudamed) will only be operational once all modules are fully functional and an independent audit has been conducted, so the commission has decided to launch the database simultaneously for both medical devices and invitro diagnostics together in May 2022. After the device registration modules are released, Mindray will start up the EUDAMED device registration by the highest priority, and inform all cooperators in EU.
According to MDR, UDI requirement shall be applied：
1. from 2021.5.26 for implantable devices and for class III devices;
2. from 2023.5.26 for class IIa and class IIb devices;
3. from 2025.5.26 for class I devices. Mindray has finished the UDI assignation and attached the label with UDI on all medical devices sold to EU since manufactured after 2021.1.1.
According to IVDR, UDI requirement shall be applied：
1. from 2023.5.26 for implantable devices and for class D devices;
2. from 2025.5.26 for class B and class C devices;
3. from 2027.5.26 for class A devices. Mindray has finished the UDI assignation and attached the label with UDI on all in vitro diagnostic instruments sold to EU since manufactured after 2021.1.1. For IVD reagents, UDI will be finished before the above timeline based on IVDR. The UDI is indicated by QR code or bar code.
Mindray’s Transition Schedule from MDD/IVDD to MDR/IVDR
From 2017，Mindray has set up a special team (including regulation experts, quality experts, clinical experts, after-sales supervisors, R&D managers, production managers, marketing directors, and other relevant professionals) to evaluate the impact on products and manufacturers, by interpreting MDR regulation and repeatedly communicating with external audit institutions. Review the new requirement for the existing technical documents, check if the existing clinical evidence and risk management conform with MDR, identify any discrepancy defects, update the relevant requirements.
For QMS, to meet the requirements of the MDR/IVDR in terms of the standards and procedures met by medical devices, include the requirements of quality management system, appoint the person in charge of compliance work, and ensure that the person has sufficient qualifications. Improve the obligations of legal persons and operators, ensure the management awareness and staff capability meet the new regulations. Review supply chain terms and clarify roles and responsibilities of business partners (authorized representatives, importers, distributors, etc.).
For MDR/IVDR marketing approval, after communicating with the notified body, formulate a audit implementation roadmap, actively cooperate with the notified body, and complete document preparation, system upgrade, on-site audit, and related rectification. In 2019.11, Mindray obtained the first MDR CE certificate in Asia Pacific for ultrasound products, and in 2020.12, Mindray obtained the first IVDR CE certificate in China for Immunoturbidimetric reagents demonstrating the advantages of Mindray in terms of MDR&IVDR regulatory compliance.
The regulations MDR/IVDR allow for transition period set in the regulation, Mindray’s product will be continuously compliant with MDD/IVDD Directive during the transition period. Then before the deadline of transition period, they will reach compliance with MDR/IVDR regulation.
Above all, Mindray has ability to supply you with the valid EC certificate and CE marked products under MDD/IVDD or MDR/IVDR and fully comply with all the regulation requirements.
Q & A for Importer and Distributor under MDR/IVDR
What is an Economic Operator as Importers/Distributors?‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market.
‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.
What’s the difference between the MDD/IVDD and the new MDR/IVDR?a) The MDR reclassifies certain devices and has a wider scope. For instance, the MDR explicitly covers all devices for cleaning, sterilizing or disinfecting other medical devices (Article 2.1); reprocessed single-use medical devices (Article 17); and certain devices with no intended medical purpose (Annex XVI).
The IVDR introduces a new rule-based classification system including Class A (lowest risk), Class B, Class C, and Class D (highest risk). Class A in sterile condition, Class B, C, and D IVDs will require certification by a Notified Body NB involvement as part of their conformity assessment. Only the lowest classification class A devices do not need NB involvement with the exception of Class A devices that are sterile (Article 48). The new rule-based system supersedes the current list-based approach in the Directive. This change means that, as classification rules will be applied to all IVD medical devices, around 85% of IVD medical devices will require a notified body for conformity assessment, compared to 20% under IVDD.
b) The MDR introduces a clinical evaluation consultation procedure for some Class IIb devices and for implantable Class III devices by an independent expert panel.
IVDR introduces a more detailed procedure and requirements of performance evaluation and post-market surveillance for all IVD medical devices.
c) A new Unique Device Identification system will significantly enhance the traceability and the effectiveness of post-market safety-related activities.
d) The MDR/IVDR will also provide increased transparency, with information on devices and studies being made public. The new European Database for Medical Devices – EUDAMED – will play a central role in making data available and increasing both the quantity and quality of data.
Will there be a difference in CE marking of a medical device?As for MDR, the same CE marking attached on the labelling, although standing for the MDR Regulation instead of MDD Directive. As for IVDR, CE marking of medical devices classified from others(IVDD) to Class B/C/D(IVDR) is changed from CE to CE with Notify Body number because of increased Notified Body involvement. Mindray will supply you with the valid EC certificate or DOC and CE marked products under MDD/IVDD or MDR/IVDR and fully comply with all the regulation requirements by EU.
How can I recognize when a product’s CE mark is under MDD/IVDD or MDR/IVDR?Check the Declaration of Conformity for your product. If a customer is unable to find a DoC, please contact Mindray to request it based on the device’s serial number, product name and REF number or model (if applicable).
After 2021.5.26 or 2022.5.26, if we sell the devices under MDD or IVDD Directives, will there be any discrimination in eligibility criteria in public tenders?No.
According to European Commission official document, Factsheet for competent authorities in nonEU/EEA countries Page 3 indicate that “During the transition period, products certified under the Directives and products certified under the Regulations will coexist on the market. Both will have equal status under the law, provided that they are accompanied by appropriate certificates, and no discrimination in eligibility criteria in public tenders may take place. Certificates issued by Notified Body (For IVDD, only List A/B products have such certificates) under the Directives will remain valid, under certain conditions, until 26 May 2024 at the latest. During the remaining validity of a certificate, a device can be covered by both a Directive certificate and a Regulation certificate”
Must economic operators enter all relevant information into EUDAMED by 2021.5.26(for MDR) or 2022.5.26(for IVDR)?No.
Even if EUDAMED is fully functional at 2021.5.26, there will be an 18-month “interim phase” during which the relevant information according to Art. 56 para 5 MDR may be registered in EUDAMED “step by step = certificate by certificate” instead of nationally according to the Directives. However, at the end of this “interim phase” it must be ensured that all the relevant data regarding all certificates have been registered in EUDAMED. For IVDR, the relevant data should be registered in EUDAMED within the date corresponding to six months after the date of publication of the notice that EUDAMED is fully functional. Till 2021.5, EUDAMED only release the actor registration module, the device registration module is postponed. The European Commission concluded that its database of medical device information (Eudamed) will only be operational once all modules are fully functional and an independent audit has been conducted, so the commission has decided to launch the database simultaneously for both medical devices and in-vitro diagnostics together in May 2022. After the device registration modules are released, Mindray will start up the EUDAMED device registration by the highest priority, and inform all cooperators in EU.
Must all devices sold to EU attach with the UDI label?No.
According to MDR, UDI requirement shall be applied：
a) from 2021.5.26 for implantable devices and for class III devices;
b) from 2023.5.26 for class IIa and class IIb devices;
c) from 2025.5.26 for class I devices.
While, Mindray has finished the UDI assignation and attached the label with UDI on all medical devices sold to EU since manufactured after 2021.1.1.
According to IVDR, UDI requirement shall be applied：
a) from 2023.5.26 for class D devices;
b) from 2025.5.26 for class B and class C devices;
c) from 2027.5.26 for class A devices.
Mindray has finished the UDI assignation and attached the label with UDI on all in vitro diagnostic instruments sold to EU since manufactured after 2021.1.1. For IVD reagents, UDI will be finished before the above timeline based on IVDR.
Will Mindray have new requirements for Business Partners/Distributors?Yes. Mindray has updated the partnership contracts as regulation compliance articles to reflect these changes.
* For any additional questions about MDR&IVDR regulation, please contact us: MindrayRA@mindray.com