Global ISO Requirements

Global ISO Requirements

What is ISO?

ISO – International Organization for Standardization, is the international, non-governmental body for drafting and establishing technical and non-technical standards. These standards are developed by different committees within the ISO. Having around 165 member states, with one representative from each, ISO is a global entity catering to the needs of industry requirements.

Are ISO standards important?

The ISO medical device standards are the Bible for many countries, especially ones which do not have predefined regulations or processes. For regulated countries, in addition to their respective regulations and guidance, ISO standards are also preferred. The most popularly referred ISO standard is the ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes. In addition to general standards, ISO also publishes product-specific guidance such as for Implants, Orthopedic, Medical Electric Equipment, and many more.

Global ISO Requirements

In Europe, the European Commission has the Medical Device Regulation MDR 2017/745 and In-vitro Diagnostic Device Regulation IVDR 2017/746. These regulations provide a detailed framework for introducing a medical device in the European market. However, in addition to that, certain ISO standards may also be referred to for ensuring a better-quality product. Some of the many popularly used standards include:

  • ISO 14971:2019 Medical Devices – Application of Risk Management to medical devices
  • ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
  • IEC 60601-2-83 Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
  • IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

The European Commission also has Harmonized Standards, developed by European Standards Organization CEN, CENELEC, or ETSI, per the international standards. It provides a list of the applicable harmonized standards for enhanced product safety and quality.

In the USA, the US Food and Drug Administration (FDA) has a Code of Federal Regulations (CFR) and Guidance.

  • CFRs are legally binding. Manufacturers must comply with the requirements of CFR
  • The guidance provides Agency’s thinking on regulatory issues. They are NOT legally binding

In addition to these, the FDA also accepts certain recognized consensus standards from different organizations such as ISO, CLSI, ANSI, IEC, CEN, etc. These standards may be used to justify a Declaration of Conformity for a product. The widely accepted medical device ISO standards are, but are not limited to:

  • ISO 10993 – Biological Evaluation for Medical Devices
  • ISO 14160 – Sterilization of Healthcare Products
  • ISO 11737 – Sterilization of Medical Devices

In Canada, the Standards Council of Canada (SCC) is the ISO member body. Similar to the US FDA, the Therapeutic Products Directorate (TPD) of Health Canada periodically releases a list of acceptable international or national standards for medical devices. Manufacturers can use these recognized standards in conjunction with the Health Canada’s Medical Devices Regulations (SOR-98/282) and the Guidance Documents, to prove product conformity and safe use in the market.

China‘s National Medical Products Administration (NMPA) is developing indigenous standards that more closely align with those of ISO. Biocompatibility testing is one avenue where the scope and requirements for China are more than that of the US/EU. Hence, NMPA has developed various biocompatibility testing standards which are to be used in addition to the ISO standard.

For the rest of the world’s medical device industry,

  • India encourages ISO certification for all its industries. The medical sector must be ISO 13485 compliant while the pharmaceutical sector must be ISO 9001 compliant for Quality Management Systems, in addition to other relevant and applicable ISO standards.
  • Japan’s The Japanese Industrial Standards Committee (JISC) is an ISO member body. The regulatory authority, Pharmaceutical and Medical Device Agency (PMDA) revised its Ordinance No. 169 in 2021 to closely align with the ISO 13485:2016 standard. The transition period is 3 years and must comply by March 25, 2024
  • For the Korean regulatory authority, aligning the requirements of Korean Good Manufacturing Practice (GMP) to that of ISO 13485:2016 is believed to be a step closer to entering the Medical Device Single Audit Program (MDSAP)
  • Russia’s Federal Service for Surveillance in Healthcare (Roszdravnadzor) is known to accept ISO 13485:2016 certification. Information on acceptance of other ISO standards cannot be confirmed. It does not accept market approvals in the US, EU, or other countries as a reference for market authorization in Russia
  • Australia’s Standard Australia is a member of the ISO, IEC, and ICSID. It strongly encourages the use of international standards, except where their use is ineffective or inappropriate and does not develop any national Australian standard for which there is already an international standard in existence. In 2019, TGA published Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019 which provides a list of applicable conformity assessment standards.
  • Brazil’s ANVISA accepts Good Manufacturing Practices (GMP) along with the ISO 13485

FAQs

Can QMS be established solely based on ISO standards?

For countries that do not have their own QMS regulations, the ISO standard can be used as a reference. For countries with established local regulations, and that accepts ISO, both ISO standard and local/national regulations must be considered.

Are ISO standards freely available?

No. ISO standards are available for purchase from the ISO official website. However, they do have FREE read-only formats available.

Comparing ISO standards to local regulations, which one takes precedence?

The local or national regulation always takes precedence over the ISO standard.

Can the manufacturer use an older version of an ISO standard for compliance?

No. Manufacturers must make sure they comply with the active or most recent version of the ISO standard. This is not restricted just to ISO standards but applies to National regulations too. Manufacturers must keep their QMS up to date with the latest requirements of the industry. The ideal way to be updated is to refer to the latest version of any Standard or Regulation.

Quality Management System Requirements of EU MDR

Quality Management System Requirements of EU MDR

Quality Management Systems (QMS) are defined by the MDR as formalised systems that document processes, responsibilities, and procedures to ensure and continually improve the standard of company activities. To obtain CE marking and market devices in European Union, an effective Quality Management System that complies with EU MDR 2017/745 is must.

Article 10 of EU MDR 2017/745 explains the general obligation of manufacturers to place their products in the EU market. Article 10 of the EU MDR 2017/745 also comprises the requirements for implementing and maintaining a Quality Management System capable of addressing particular issues to ensure device quality and safety. Manufacturers of devices are expected to establish, document, implement, maintain, and keep up to date all the device documents to continually aid the improvement of the quality management system.

QMS for EU MDR

Quality Management System (QMS) must address at least the following:

  1. A strategy for regulatory compliance, which includes conformity assessment procedures and procedures for change management and control for the device
  2. The system must consist of general safety and performance requirements and methods to address the same
  3. The system must define the management’s responsibility
  4. The system must include resource management methodologies which should contain information on the selection and control of suppliers and sub-contractors
  5. The system must include risk management methodologies as per Section 3 of Annex I
  6. The system must include clinical evaluation data along with post-market clinical follow-up (PMCF) as per Article 61 and Annex XIV
  7. The system must include data on product realization, which should involve information such as planning, design, development, production, and service provision
  8. The system must ensure the verification of the UDI assignments as per Article 27(3) for all relevant devices and should also ensure consistency and validity of the information provided as per Article 29
  9. The system must contain data on the setup, implementation, and maintenance of a post-market surveillance system as per Article 83
  10. The system must include communication protocols with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders
  11. The system must include methodologies for reporting serious events and field safety corrective actions in the context of vigilance
  12. The system must also include methodologies of management of corrective actions and verification of their effectiveness
  13. The system must include data on processes for monitoring and measurement of output data, data analysis and product improvement

Mapping of ISO 13485:2016 clauses to the MDR QMS requirements

FAQs:

How will a QMS be assessed under the EU MDR?

The quality management system of a manufacturer will be evaluated as part of the EU MDR Annex IX to XI- conformity assessment procedures. A Notified Body will do conformity evaluation for all devices except Class I.

Can ISO 13485:2016 QMS certificate holders bypass or claim EU MDR compliant QMS by themselves?

No, to be compliant with EU MDR the manufacturer is required to obtain a QMS assessment w.r.t Article 10(9) by a notified body in case of Class II & III. For a class I, the manufacturer must establish a corresponding QMS and include the same declaration in the self-declared DoC

Is 13485:2016 mandatory for MDR in addition to Article 10(9)?

No, the ISO 13485:2016 is not mandatory. However, the Quality Management System ISO 13485:2016 ensures entry to various global markets.

EU MDR – Article 117

EU MDR – Article 117

The French Poly Implant Prostheses (PIP) breast implant controversy prompted medical rules to be revised and formed new Medical Devices and In-Vitro Devices Regulations to safeguard public health. As per the European Medicines Agency (EMA) definition, a medicinal device is a substance or combination of substances intended to treat, prevent or diagnose a disease, or restore, correct or modify physiological functions by exerting a pharmacological immunological or metabolic action.

Medical devices, or device parts, are increasingly being produced for use with medicinal items, which might range from a basic prefilled syringe to more complex autoinjectors to medical devices incorporated as sensors in tablets. Regulatory bodies have created specialised capabilities and requirements over the last decade due to the increased integration of medicines and devices seen in the latest generation of combination products. To achieve fast and proper market access for new combination products, manufacturers must adequately understand the unique requirements in each country, and the development of combination products entails a specific pattern of engagement between manufacturers and regulatory bodies. Based on their primary mode of action, products that combine a medicinal product (or substance) and a medical device are governed by Regulation (EU) 2017/745 or Directive 2001/83/EC.

How is a product categorised as a medicinal product or a medical device based on its mode of action?

As per the EU MDR 2017/745, the product is controlled as a:

  • medical device when the action of the medicinal substance is auxiliary to the action of the medical device,
  • medicinal product when the action of the medicinal substance is prominent and not supplementary to the action of the medical device.

For example, an insulin injector pen’s principal action is insulin administration. As a result, the injector pen will be classified as a medicinal product.

The necessity of a declaration of conformity and an EU certificate issued by a notified authority for the evaluation of compliance of the device part and the Drug-Device Combination marketing authorisation dossier is the most significant change brought about by Article 117 of EU MDR. Suppose these conformity assessment documents are excluded from the dossier. In that case, the applicant will be asked to give an opinion from a notified body on the device part’s compliance with the relevant requirements of EU MDR Annex I. A notified body is a conformity assessment service provider appointed by the National Competent Authority to assess the conformity of medical devices before being placed on the Union market.

When the device is integrated with a medicinal substance where the action of that substance is principal, or when the medical device administers a medicinal product forming a single integral product, such devices are considered an integral product (combination of medical device and medicinal product). They shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004 and the relevant general safety and performance requirements set out in Annex I of Regulation (EU) 2017/745. The devices must meet the following criteria before they may be placed on the market:

  • The device and the medicinal product should be combined into a single integral product
  • The single integral product should not be reused
  • The single integrated product is only meant to be used in combination

Marketing Authorisation Applications (MAA)

An application by the Marketing Authorisation Holder (MAH)/applicant to a European regulatory body seeking authorisation to commercialise a pharmaceutical inside the European Union is known as a Marketing Authorisation Application (MAA). Once obtained, the centralised marketing authorisation is valid in all EU Member States and EEA-EFTA countries (Iceland, Norway, and Liechtenstein). According to Annex I of Regulation (EU) 2017/745, the MAA shall provide the following for a combination device starting on 26 May 2021:

  • Declaration of Conformity, and the CE certificate issued by a notified body for the device part having a CE mark
  • An opinion from a notified body on the conformity of the device part, if it does not hold a CE mark, Declaration of Conformity, and the CE certificate irrespective of the class of the device
  • Additional information of the benefit/risk assessment of the medicinal product when requested
  • Where a CE mark has not been issued to the device component on its own, the manufacturer must reach out to a NB and obtain their opinion on the device conformity and provide the NBO report in the MAA

In case the documents mentioned above are issued following the Medical Device Directives 93/42/EEC or 90/385/EEC, then they are still valid and can be used to support the requirements throughout the transition period, which lasts until 26 May 2024.

According to the European Medicines Agency (EMA) or the National Competent Authority (NCA), these documents must be provided in the initial MAA for the medicinal product, and if not, they must be produced before an opinion on the medicinal product application may be granted. Failure to submit the appropriate documentation may cause the evaluation period to be delayed.

If any changes to the design, intended purpose of the device part, or a new version are launched after the Marketing Authorization has been granted to the manufacturer, the necessary declaration of conformity, CE certificate, and notified body opinion should be submitted to the EMA/NCA. If the revisions influence the device’s quality, safety, or efficacy, the applicant/Marketing Authorisation Holders (MAH) must file a variation application, consulting the Medicines Competent Authority that gave the marketing authorisation (if the change is unclear). As part of regulatory compliance, the relevant member states require the Mutual Recognition Procedure (MRP)/Repeat Use Procedure (RUP) application after submitting the variation application. The dossiers for this application include the General Safety and Performance Requirements (GSPR) of the MDR and Annex I of Directive 2001/83/EC, Section 3.2’s point 12 of Directive 2001/83/EC as amended by Article 117 of the MDR, and supporting documents like the declaration of conformity, certificate of conformity or notified body opinion.

The European Public Assessment Report (EPAR) contains information on the submission and evaluation of materials, procedures, findings, and conclusions of the marketing authorisation application (MAA) to the EMA/NCA.

Co-Packaged Medical Devices

If a medical device is provided as part of the secondary packaging of a marketed medicinal product (co-packaged) and does not form an integral part of the medicinal product, the Marketing Authorisation Holder/applicant must ensure that their co-packaged medical device is CE marked, meets the MDR’s general safety and performance requirements, and is entirely compliant with the MDR before it can be placed on the market. Spoons, measuring cups, inhalers, and spacers are co-packaged medical devices. MDR 2017/745 must be followed by self-CE marked Class I devices.

Article 117 of the Regulation requires Notified Body involvement for European market authorisation of a medicinal product that incorporates an integral medical device or drug-device combination product. The EMA has released an FAQ to help the combination products’ manufacturers understand Article 117 requirements better. Manufacturers must keep in mind that the summary report of NBO will be issued by the notified body only after they verify if all the GSPR requirements are met adequately. Based on their opinion report, the medicines agency decides on the products’ MAA.

FAQs

Is the NBO report mandatory to be submitted to the MAA?

There are 2 ways to do this:

  • If the device is CE marked already, the manufacturer must submit a DoC and a copy of the CE certificate for the device.
  • If the device is not CE marked, obtain the NBO report (assessment of GSPR) and submit it to the authority along with your MAA application.

What is a Single Integrated Drug-Device product?

If a medical device used to administer a medicinal product is placed on the market in such a way that the device and medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable.

What are a few examples of Drug-Device Combination products?

Pre-filled syringes, inhalers, pre-filled pens, an antibody combined with a therapeutic drug, transdermal patches, and insulin pump.

Co-packaging examples are a Drug or vaccine vial packed with a syringe and a dose-dispenser medication.

Nomenclature of medical devices

Nomenclature of medical devices

Medical devices are those products used to prevent, diagnose, treat, and monitor the many diseases known to humankind. Medical devices and medicines play an equally important role in treating human beings. To learn more about medical devices, read our article on the definition of a medical device. This article discusses the nomenclature of medical devices and examples of these.

What is the nomenclature of medical devices?

To simply put it, the nomenclature is the naming of a medical device. Although medical devices are classified into different risk classes, they should be named so that it is universally identified. Standardised nomenclature facilitates this easy identification.

A nomenclature is needed to simplify trade and tracking among the different regulatory authorities, Ministries of Health, and other organisations that regulate medical devices.

A standardised nomenclature aids in the following aspects:

  • Grouping and classification of medical devices.
  • Registration under different regulatory bodies or Ministries of Health
  • Streamlined procurement and distribution
  • Grouping of medical devices in various electronic health records and medical device databases
  • Vigilance reporting, field safety and post-market surveillance
  • Unique Device Identifiers (UDI)

Medical Device Nomenclatures

The different device nomenclatures available are as follows:

  • GMDN or Global Medical Device Nomenclature.
  • EMDN or European Medical Device Nomenclature
  • UMDNS or Universal Medical Device Nomenclature System
  • Other nationally developed nomenclature systems

Global Medical Device Nomenclature (GMDN)

About 10% of countries use Global Medical Device Nomenclature worldwide. It is a system of internationally accepted descriptors used to identify medical devices. The GMDN Agency manages GMDN codes, a non-profit organisation.

GMDN is a 5-digit code containing the following information:

  • GMDN Term Name: Anaesthesia ventilator
  • GMDN Code: 34851
  • GMDN Definition: A mains electricity (AC-powered) stand-alone, automatic cycling device used to assist and control alveolar ventilation during general anaesthesia and is compatible with inhaled anaesthetic agents. It has fewer functions and is less complex to operate than an intensive care ventilator but adequately meets the patient’s ventilation needs for oxygen (O2) and carbon dioxide (CO2) exchange to maintain normal blood gas concentrations. The device provides a mechanical means to deliver the breathing gas to the patient in a controlled pattern. It is equipped with alarms to warn of changes in respiration or the onset of unsafe operating conditions.

Source: gmdnagency.org

GMDN was introduced for a variety of regulatory purposes. GMDN is based on the ISO 15225: Medical device nomenclature data structure’. Read more about the frequently asked questions about GMDN here.

European Medical Device Nomenclature (EMDN)

European Medical Device Nomenclature or EMDN is introduced due to Article 26 of EU Regulation 2017/745 of Medical devices and Article 23 of EU Regulation 2017/746  of in-vitro diagnostic medical devices. Like GMDN, it plays a considerable role in device nomenclature and serves various regulatory purposes. One of the primary uses is while registering a medical device in EUDAMED where it is closely linked to UDI-DI.

Structure of EMDN

The European Medical Device Nomenclature is characterised by its alphanumeric structure and is established in a seven-level hierarchical tree where it clusters medical devices into three primary levels:

Categories: the first hierarchical level – alphanumeric.

Groups: the second hierarchical level – 2 numbers indicating group.

Types: the third hierarchical level – a series of numbers 1,2,3,4 and 5.

EMDN was adopted from the Classificazione Nazionale Dispositivi medici (CND) classification. The EMDN can be accessed at the EMDN list. European Medical Device Nomenclature categorises into three primary levels, categories, groups, and types. A category comprises several groups composed of various kinds of medical devices.

Source: https://webgate.ec.europa.eu/dyna2/emdn/. In the above image of EMDN, ‘A’ is the category, ‘A01’ is Group and ‘A0101’ to ‘A0199’ are the types of medical devices.

Universal Medical Device Nomenclature System (UMDNS)

Universal Medical Device Nomenclature System or UMDNS was developed by the Emergency Care Research Institute (ECRI). Many nations have adopted this standard around the world. UMDNS is used in inventory control, work order control, and regulatory systems applications. It is a 5-digit code unique code and a term for different types of medical devices. One can find the UMDNS code list here. UMDNS is updated monthly.

CND Nomenclature

CND nomenclature or ‘Classificazione Nazionale Dispositivi medici’ was developed by Italian Ministry of Health. In addition to Italy, it is also used in Portugal and Greece. The guidance document on CND nomenclature explains the basic principles and structure of CND, which also applies to EMDN as EMDN was adopted from CND nomenclature. Following this, medical devices are clustered into three levels:

  • Category
  • Group
  • Type

FAQs

Is UDI the same as GMDN?

Both Unique Device Identification System (UDI) and GMDN are used in device identification. However, the two have some fundamental differences. UDI is inferior because of its lack of unity. It does not have a structure; therefore, device identification becomes more difficult with UDIs. Nonetheless, it is an effective tool for the traceability of medical devices. FDA utilises UDIs for medical device identification. The user guide to GUDID explains how the UDIs are managed in US FDA’s database, GUDID.

Can EMDN be accessed free of charge?

The EMDN is accessible to all stakeholders- free of charge. Hence, it can be utilised by a non-exhaustive list of stakeholders such as manufacturers, patients, research organisations, practitioners, hospitals, etc. The EMDN can also be downloaded from here.

Is there a guidance document that helps economic operators to map the EMDN information into the forthcoming EUDAMED database?

Yes, there are two guidance documents released by the EU commission

Updates in ANVISA GMP 2022 document 

Updates in ANVISA GMP 2022 document 

Agência Nacional de Vigilância Sanitária – ANVISA is the Regulatory Body of Brazilian government.  

What is Good Manufacturing Practice (GMP)? 

Good manufacturing practices are the procedures that must be followed in order to comply with the guidelines set forth by regulatory agencies that oversee the authorization and licencing of the manufacture and sale of medical devices. 

The GMP document released on 30th March 2022 for Medical and IVD products replaced the GMP document released by ANVISA in 2013. In this article, we will discuss the Significant changes that were made in the latest 2022 Regulations, which supersedes the 2013 version. 

  1. In Art 35 2022 GMP Document, under the document review and archive section, it is explicitly mentioned that – “All digitally stored documents and records shall be backed up.”  
  1. In Art 71 2022 GMP Document, under the Personal health and hygiene section, it is now clearly explained that – “Any individual who, upon medical examination or observation by supervisors, appears to be in a health condition which could affect the product shall be removed from operations until the health condition is deemed adequate.” 
  1. In Art 87 2022 GMP Document under labels and instructions for use, there is an additional point which states – “In the case of importers, the approval documentation referred to in “Labels and instructions for use” article may be recorded in a specific document in lieu of the history record of the product.” 
  1. In Art 112 2022 GMP Document under Distribution Records section, it is now mentioned as:   

Each manufacturer shall maintain distribution records which include or reference: 

I – the name and address of the consignee. 

II – risk: combination of probability of occurrence and severity of damage. 

III – any number control used for traceability. 

Previously in the 2013 GMP document, it was mentioned as: 

Each manufacturer shall maintain distribution records, including or making reference to: 
(i)Names and addresses of the consignee;                                
(ii) Identification and amount of products shipped, with shipment date;  
(iii) Any numerical control used for traceability.  

  1. In Art 114 2022 GMP Document under Identification and traceability of batch production units’ section, there is an additional point added which states- “Each manufacturer shall establish and maintain a program for maintenance, adjustment and, where necessary, cleaning of equipment to ensure that all manufacturing specifications are met.” This is in addition to the identification of the units that are manufactured with every product history record. 
  1. In Art 118 2022 GMP Document, under the Non-conforming components and products section, there is an additional point added which states – “The disposal of the products referred to as “non-conforming” shall be documented, and a record of the justification and manual or electronic signature of the person-in-charge for the disposal of such non-conforming products or components shall be kept.” 
  1. In Art 120-VIII 2022 GMP Document, under the Corrective and preventive actions section, there is additional information added which states – Each manufacturer shall establish and maintain procedures to determine the collection of products and other field actions for those products that are already distributed. The quality process to determine the corrective actions in regard to the identified potential causes shall be based on a valid statistical technique for detecting recurring quality problems, where applicable.” 
  1. In Art 123 2022 GMP Document under the Quality Audit section, there is an additional point added which states – “Those in charge of conducting the quality audit cannot be directly responsible for the matters under audit.” 
  1. CHAPTER 10 in 2022 GMP Document (Final Provisions) is additionally introduced – The chapter includes rules such as:  
  • “The documentation evidencing compliance with the requirements set out in this Resolution shall be made available whenever requested by the health regulatory agencies.” 
  • “Failure to comply with the provisions contained in this Resolution constitutes a health violation, under the terms of Law No. 6.437, of August 20, 1977, without prejudice to applicable civil, administrative and criminal liabilities” 
  • “The following are hereby revoked: 
    I – the Resolution of the Collegiate Board of Directors – RDC No. 16, of March 28, 2013, published in the Federal Official Journal No. 61, of April 1, 2013, Section 1, p. 75;  

II – Normative Instruction – IN No. 8, of December 26, 2013, published in the Federal Official Journal No. 252, of December 30, 2013, Section 1, p. 758.” 

Source: RESOLUTION RDC No. 665, OF MARCH 30, 2022 – RESOLUTION RDC No. 665, OF MARCH 30, 2022 

FAQ 

When will this Resolution come into effect? 

This Resolution comes into force on May 2, 2022. 

What are the terms that got replaced in the new document? 

2013 2022 
Regulation Resolution 
Device history record Product history record 
Device Master Record (DMR) Product Master Record (RMP) 
Compliance Conformity 
Guidance On Class I Medical Devices

Guidance On Class I Medical Devices

The EU MDR 2017/745 imposes more stringent requirements for Class I devices. Under the new regulations, Manufacturers must righty classify a medical device and provide technical documentation following the device class. The risk class under MDD could change under MDR. In some cases, medical devices could be up classified from Class I to Class II a/b or Class III. Please read our article on the classification of medical devices to understand how to classify your current device per MDR.

MDCG guidance on Class I medical devices is a valuable resource document for Class I Manufacturers. Manufacturers can place the devices by following the steps mentioned below.  

Steps for placing a Class I Medical Device.

Step 1: Integrate MDR into the existing Quality Management System.

This allows the correct documentation to be created following the risk classification of the device.

Step 2: Confirm whether the product is a medical device under the scope of MDR.

Confirm that the product meets the definition of a medical device as stated in Article 2 of EU MDR based on its intended use and primary mode of action. In some cases, the product may be out of the scope of MDR and may be termed as a medical device ‘accessory ’. EU MDR also states how accessories for a medical device is also to be classified on its own apart from the main medical device.

Step 3: Confirm whether the medical device is a Class I medical device.

It must be noted that several MDD Class I devices will be reclassified under the MDR as per the new classification criteria in Annex VIII, such as most software (rule11) and devices made up of chemicals or combinations of substances (rule 21).

Step 4: Pre-market procedures.

  • Verify that the device meets the General Safety and Performance Requirements (GSPR).

A proper and well-established risk management system should be implemented. Manufacturers must ensure that the associated risks are identified, analysed and appropriate corrective actions are taken. This must be guaranteed throughout the product’s lifecycle and documented. When standard specifications are available, Manufacturers must adhere to them unless they can demonstrate that they have adopted a solution that is at least as safe and effective.

The Manufacturer should periodically update the clinical evaluation report, risk management and post-market reports.

  • Conduct Clinical evaluations

All devices require clinical evaluation, Class I devices are not exempted from this requirement. A clinical evaluation report must contain essential information such as device descriptions, literature reports and post-market surveillance reports to name a few. MDR also emphasises the need to consider available alternatives and the acceptability of the benefit-risk ratio.

  • Prepare an up-to-date technical file.

The Manufacturer will draw up the technical documentation that demonstrates the conformity of their devices with the specific requirements of the MDR. Technical documentation is mentioned in Annex II and III of EU MDR.

The Manufacturer is obligated to keep the file updated and make them available to competent authorities, notified bodies and the authorised representative.

  1. The technical file must contain the following elements. The detailed information can be found in Annex II of EU MDR.
  2. Device description and specification, variants, and accessories
  3. Information to be supplied by the Manufacturer
  4. Information on Design and manufacturing
  5. General Safety and Performance Requirements
  6. Benefit-risk analysis
  7. Risk management
  8. Verification and validation of product
  9. Demonstration of Conformity

The documents in the technical file should be made available in the language accepted in the Member State in which the device is sold. Please read our article on EU Requirements for translations to understand this requirement specified in EU MDR.

  • Involvement of Notified Bodies

Most Class I devices do not require the involvement of a Notified Body. However, device Classes ‘Ir’, ‘Is’ and ‘Im’ have this requirement. ‘Ir’ devices are those which are reusable instruments. ‘Is’ are devices to be used in a sterile condition. ‘Im’ are those devices with a measuring function. For these devices, the involvement of Notified Bodies is limited to audit and the NB assesses those specific controls. For example, an “Is” device assessment of NB would involve auditing the Sterilisation process and controls.

  • Prepare Instructions for Use and Labelling

Medical device manufacturers must ensure that the instructions for use and labels are available in languages accepted within the Member State they decide to market in. The instruction for use must indicate the safety and performance information so that its users are aware of its intended use. The instructions for use (IFUs) should have drawings and internationally accepted symbols. Read our article on Information to be supplied by manufacturers to understand more about this topic. 

Step 5: Draw up a Declaration of conformity.

The Declaration of conformity (DoC) is a document signed by the Manufacturer that states the device fulfils the requirements set forth by MDR. For more information, read our article on Declaration of conformity.

Step 6: Affix CE mark.

CE mark should be placed on the medical device to show compliance. If it cannot be placed on the product itself, it must be placed on the packaging.

Step 7: Registration on EUDAMED

Before placing in the EU market, all devices must be registered on EUDAMED. EUDAMED is a secure, web-based European Databank on Medical Devices. Although Class I devices are not much of a threat to human life, they must be made available on EUDAMED. It ensures that the device information is accessible to the public.

Transitional provisions

Transitional provisions are in place to help manufacturers transition to MDR from the directives. Article 120 of EU MDR gives an idea of the exemptions from MDR and greatly helps manufacturers by providing more time to meet the requirements.

The following conditions must be met to be able to market a device according to Directive 93/42/EEC until 26 May 2024:

  • The device complies with Directive 93/42/EEC.
  • The device has not undergone significant changes in device design or intended purpose.
  • The device has a valid Declaration of Conformity (DoC)
  • The post-market surveillance, Market Surveillance, Vigilance and Registration of economic operators and devices requirements are met.

FAQs

Does a Class I Device manufacturer require an ISO certificate for the Quality Management System?

Not necessarily. The Class I manufacturer must have an established QMS, and obtaining a certification is not mandated. Although globally, there is a significant benefit for the Manufacturer to hold an ISO QMS certification. Major markets worldwide accept ISO 13485 certificate as one of the key entry factors into their geography. A few key markets, such as Canada, Japan, Australia, Singapore, and Malaysia, require ISO Certification. The ISO 13485 certificate is recognised worldwide as a significant standard for a quality management system for medical device manufacturers.

Should Class I Device DoC contain the reference to MDR Annex (s)?

Yes, but this has been considered of less importance while drafting the DoC. Declaration of Conformity (DoC) must mention the respective Annex(s) in the MDR that it has complied with for any device class. This is one of the required information to be entered while performing product registrations in many countries.

What is the conformity procedure for Class I devices?

The conformity procedure for all Class I devices is mentioned in the flow chart.

Source: MDCG Guidance document for Class I manufacturers