MDR – Article 10 – General Obligations of Manufacturers

MDR Article 10 - General Obligations of Manufacturers

Whereas old Medical Device Directive has these obligations but new Medical Device Regulation has new ones that are more detailed.

Here are the manufacturer’s basic obligations to produce a medical device according to MDR Article 10 – General Obligations of Manufacturers.

Article 10 - General Obligations of Manufacturer

1

When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation.

2

Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I.

In order to have a well designed risk management system, EN ISO 14971 (Application of risk management to medical devices) and EN ISO/TR 24971 (Guidance on the application of ISO 14971) requirements are met in your factory.

3

Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF

Article 61 describes clinical evaluation. This subject is crucial for MDR. You better create a procedure called “Clinical Evaluations” and detail it base on Article 61, Annex XIV and Meddev 2.12/Rev 2.

4

Manufacturers of devices other than custom-made devices shall draw up and keep up to date technical documentation for those devices. The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed. The technical documentation shall include the elements set out in Annexes II and III.

The technical file is a document that proves that the product meets and continues to meet the basic safety requirements of the regulation with pre-market and post-market data, performs and continues to fulfill its clinical benefit and its clinical benefit is higher than its harms.

Please see the following for what should be included in a technical file:

1.COVER

  • File code
  • Product Name
  • Product Photos

2. CONTENTS

3. MANUFACTURER INFORMATION

  • Company’s name
  • Address
  • Company background information
  • Contact information
  • The person to contact about the product and the contact information of this person

4. DEVICE DESCRIPTION AND SPECS, INCLUDING VARIANTS AND ACCESSORIES

  • Device description and its specifications
  • General device definition
  • Product name or trade name of product
  • Intended use
  • Target user population
  • Traceability information
  • Basic UDI-DI information
  • Product codes
  • Catalogue codes
  • Other information allows traceability
  • Target patient population
  • Medical conditions to be diagnosed, treated and / or monitored and patient selection criteria
  • Indications, contraindications, warnings
  • Operating principles and mode of action of the device
  • Justification for qualifying the product as a medical device
  • Risk class of the device and its justification (Annex IX)
  • Description of accessories, other devices and other non-device products intended for use with the device
  • A description or a complete list of the various configurations / variants of the device intended for making it on the market
  • Diagrams showing key essential parts and functions / Mode of action (Formulation)
  • A definition of raw materials, especially those that come into direct / indirect contact with the body
  • Technical specifications such as features, dimensions and performance characteristics to be mentioned in brochures and catalogs
  • GMDN codes (www.gmdnagency.com)
  • Raw material certificates
  • Component / Critical component list and certificates
  • Human blood, drug, animal tissue declaration
  • Noxious chemical substances declaration
  • If applicable, a general statement about the previous generation or generations of the device manufactured by the manufacturer
  • If applicable, a general statement of identified similar devices available in the union market or international markets

5. INFORMATION SUPPLIED BY MANUFACTURER (EN 1041)

In accordance with the languages of the countries planned to be sold;

  • Product labels, sales and shipment labels and symbols, other symbols on the product (EN ISO 15223-1)
  • Instructions of use

6. DESIGN and PRODUCTION INFORMATION

Design stages applied to the device.

  • Production, Quality Control Process Informations and validations
  • Description of all facilities where design and manufacturing activities are carried out and the activities carried out in these facilities
  • Identifying suppliers and subcontractors, identifying facilities, defining the activities carried out there
  • Critical suppliers / subcontractors list
  • Critical suppliers / subcontractors certificates and agreements
  • Techcical drawings, Isolation diagrams

7. ( ANNEX 1 )GENERAL PERFORMANCE AND SAFETY REQUIREMENTS CHECK-LIST

In order to understand this subject, click here to view a comparison between requirements under the MDR and IVDR and the MDD/AIMDD.

8. BENEFIT-RISK ANALYSIS and RISK MANAGEMENT

  • Risk management procedure
  • Risk management plan
  • Risk management report

5

Manufacturers of custom-made devices shall draw up, keep up to date and keep available for competent authorities documentation in accordance with Section 2 of Annex XIII.

6

Where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than custom-made or investigational devices, shall draw up an EU declaration of conformity in accordance with Article 19, and affix the CE marking of conformity in accordance with Article 20.

Please click here to download a Declaration of Conformity (DoC) template

7

Manufacturers shall comply with the obligations relating to the UDI system referred to in Article 27 and with the registration obligations referred to in Articles 29 and 31.

PLEASE CLICK HERE TO VIEW ALL  MDCG DOCUMENTS.

Medical Device Coordination Group (MDCG) documents are clarifying UDI appointments: (Click them to see)

MDCG 2018-1 v3 – Guidance on basic UDI-DI and changes to UDI-DI: 

MDCG 2018-2 – Future EU medical device nomenclature – Description of requirements

MDCG 2018-3 Rev.1 – Guidance on UDI for systems and procedure packs

MDCG 2018-4 – Definitions/descriptions and formats of the UDI core elements for systems or procedure packs

MDCG 2018-5 – UDI assignment to medical device software

MDCG 2018-6 – Clarifications of UDI related responsibilities in relation to article 16

MDCG 2018-7 –Provisional considerations regarding language issues associated with the UDI database

MDCG 2019-1 – MDCG guiding principles for issuing entities rules on basic UDI-DI

MDCG 2019-2 – Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017

MDCG 2020-18 –MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers

8

Manufacturers shall keep the technical documentation, 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, available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market. In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market.

You need to keep your technical file available at least for 10 years.

9

Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation. Changes in device design or characteristics and changes in the harmonised standards or CS by reference to which the conformity of a device is declared shall be adequately taken into account in a timely manner. Manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.

The quality management system shall address at least the following aspects:

  1. A strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;
  2. Identification of applicable general safety and performance requirements and exploration of options to address those requirements;
  3. Responsibility of the management; resource management, including selection and control of suppliers and sub-contractors;
  4. Risk management as set out in in Section 3 of Annex I;
  5. Clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF;
  6. Product realisation, including planning, design, development, production and service provision;
  7. Verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29;
  8. Setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83;
  9. Handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders;
  10. Processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;
  11. Management of corrective and preventive actions and verification of their effectiveness;
  12. Processes for monitoring and measurement of output, data analysis and product improvement

10

Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article 83.

As a manufacturer, you need to plan, establish, document, implement, maintain and update a post-market surveillance system.

This system is used to;

  • update the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex I;
  • update the design and manufacturing information, the instructions for use and the labelling;
  • update the clinical evaluation;
  • update the summary of safety and clinical performance referred to in Article 32;
  • for the identification of needs for preventive, corrective or field safety corrective action;
  • for the identification of options to improve the usability, performance and safety of the device;
  • when relevant, to contribute to the post-market surveillance of other devices; and
  • detect and report trends in accordance with Article 88.

11

Manufacturers shall ensure that the device is accompanied by the information set out in Section 3 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.

“The device is accompanied by the information” means: Label and instructions for use

12

Manufacturers who consider or have reason to believe that a device which they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate. They shall inform the distributors of the device in question and, where applicable, the authorised representative and importers accordingly.

If you believe that there is something with your medical device in EU market, you should withdraw or recall  and inform your distributors and competent authorities.

13

Manufacturers shall have a system for recording and reporting of incidents and field safety corrective actions as described in Articles 87 and 88.

14

Manufacturers shall, upon request by a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language determined by the Member State concerned. The competent authority of the Member State in which the manufacturer has its registered place of business may require that the manufacturer provide samples of the device free of charge or, where that is impracticable, grant access to the device. Manufacturers shall cooperate with a competent authority, at its request, on any corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have
placed on the market or put into service.

This sentence means that you should give every document whatever the competent authority wants. Because every document is related to the conformity of the device. And you should provide a free sample of your product when related competent authority wants to see it.

In case of any incident, you should cooperate with the competent authority. If not, the competent authority is entitled to prohibit or restrict your devices placed on the market.

15

Where manufacturers have their devices designed or manufactured by another legal or natural person the information on the identity of that person shall be part of the information to be submitted in accordance with Article 30(1).

If your devices designed or manufactured by another legal or natural person, you should share the information of this person in EUDAMED.

16

Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law.

This regulation allows natural or legal persons to claim compensation for damage caused your defective device, therefore, product liability assurance is recommended.

Share This Post :

Twitter
LinkedIn

Related Posts

Products

About

Downloads