MDR Classification Rules & Types

The MDR classification rules lay the foundation for a harmonized and effective regulatory framework for medical devices within the EU.  Understanding these rules empowers manufacturers to navigate the complexities of compliance and bring safe and effective devices to the market.

By accurately classifying devices, manufacturers align with the overarching goal of the MDR – safeguarding patient health while fostering innovation in the medical device industry.

As per MDR Article, 51 Medical Devices are divided into class I, IIa, IIb, and III, taking into account the intended purpose of the devices and their inherent risks. MDR Classification is mainly based on the following factors:

  • Does the device have a standalone action?
  • How long is the device in continuous use in the human body?
  • Is it an invasive device or a surgically invasive Medical Device?
  • Is it an implantable or active medical device
  • Does the Medical Device serve the purpose of the use of certain drugs?

Type of Risk Class with Example

  • Class 1
  • Class 1 Sterile
  • Class 1 Measuring
  • Class 1 Reusable
  • Class 11a
  • Class 11b
  • Class 111
Risk Class Risk Description Example
Class III High Drug-eluting cardiac stents, Absorbable Sutures, AIMD
Class IIb Medium-High Ventilators, orthopaedic implants, Radiotherapy equipment
Class IIa Medium-Low Surgical Blades, Suction equipment
Class I sterile Low Sterile dressings, Sterile gloves
Class, I measuring Low Volumetric urine bag
Class I basic Low Non-Sterile Gloves

MDR Classification and CE Certification Process

Class 1 medical devices, according to the European Medical Device Regulation (MDR), have a low risk of causing damage to the patient and are therefore easier in nature than Class 1s, Class 1m, Class IIa, Class IIb, or Class III medical devices. The majority of Class 1 medical devices can be self-certified under EU MDR. It is not required that a Class 1 medical device be CE marked or that a Notified Body be involved. ISO 13485 introduction and certification are not needed for Class 1 component manufacturers.

QMS  enforcement is recommended as a minimum. In some words, certain controls are adequate to provide fair confirmation of the device’s protection and efficacy. By self-declaration, any Class 1 medical device may affix CE Mark. The manufacturer is responsible for ensuring that his product meets all of the Directive’s Essential Requirements and must fill out the Essential Condition Check-list.

We support class 1 Medical Device manufacturers with the following Services

  • (a) Guidance & Technical File
  • (b) Arrange Certificate of Compliance from and European Third Party.
  • (C) Arrange EU Representative from Europe
  • (d) Arrange Free Sale Certificate from Europe.

Steps before Class 1 Medical Device Self Declaration

All class 1 medical devices must go through few steps before placing them on the European market. They are the following.

  • Step 1: Research and competitor analysis and make sure the product is a medical device.
  • Step 2: Confirm that the Medical Device falls under self-declaration, i.e., class 1.
  • Step 3: Ensure that the general safety and performance requirements have been met.
  • Step 4: Clinical Evaluation performed, and Report is available as per MDR and MEDDEV 2.7/1 Rev. 4
  • Step 5: Availability of Primary & Secondary Labels and packing plans
  • Step 6: EAR Agreement for Non-European manufactures.
  • Step 7: Assure the latest revision of technical documentation is available with the declaration of Conformity.

Third-Party CE Compliance Certificate for Class I Medical Devices

Non-sterile, non-measuring medical instruments in Class 1 do not need to be certified by a Notified Body and should instead be certified by a third-party approval body. Manufacturers must realize that a third-party certificate is not needed for class 1 devices; instead, a self-attested declaration of compliance will suffice.

Class 1 Sterile Medical Device CE marking, Notified Body involvement is mandatory. Class 1 sterile manufactures should implement ISO 13485, and certification is recommended. GMP controls are necessary.

Class 1 Sterile Medical Device must comply with all the requirements for Class I devices. Establish and maintain the relevant procedures of a Medical Device Quality Management System.

Contact a Notified Body who can audit the Quality Management System and Technical Files.

Criteria for determining devices with measuring function.

The following criteria, if fulfilled together, indicate that a device has a measuring function:

  • The device intended to measure, quantitatively, a physiological or anatomical parameter, or – a quantity or a qualifiable characteristic of energy or of substances delivered to or removed from the human body.
  • The measurement results are displayed in legal units or other acceptable units within the meaning of Directive 80/181/EEC or are compared to at least one point of reference indicated in legal units or other acceptable units in compliance with the pre-mentioned Directive.
  • The intended purpose implies accuracy, claimed explicitly or implicitly.

Measuring activities during the manufacturing process, including those for calibration purposes, are not covered by this recommendation and do not imply a measuring function of the manufactured device.

Examples for Class I devices with a measuring function:

  • Non-active device for measuring body temperature.
  • Pacifier, which includes a non-active temperature display.
  • Device for indicating that body temperature is above or below a specified value.
  • Non-active non-invasive device for measuring blood pressure.
  • Non-active device for measuring intraocular pressure.
  • Device for measuring volume or flow of liquid or gases delivered to or removed from the human body.
  • Device for liquid delivery to the human body (e.g. medicine spoons, cups, droppers, without graduation or scale).
  • Device for displaying trends of physiological parameters (e.g. urine drainage bags without graduation or scale, callipers for obesity).
  • Eye-test chart

Note: – it is assumed that the relevant classification rules permit classification in Class I, provided that relevant criteria are met.

  • Class 1 Device with measuring functions are packed and supplied in a sterile condition require Notified Body Certificate, whereas the non-sterile class 1 measuring device does not!
  • ISO 13485 is Voluntary

EU MDR 2017/745 introduces new requirements for Reusable Surgical Instruments. All reusable surgical instruments fall under class 1r and are subject to conformity assessment by Notified Bodies.

Reusable Surgical Instruments are defined as “instruments intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection, and sterilization have been carried out.

MDR Class Ir CE Marking as per Article 20.1, 20.3, 20.4, and 20.5 and Article 52 (7c) can be achieved in the following methods:

  • Examination and testing of each product or homogenous batch of products (Annex IV)
  • Audit of the production quality assurance system as per Annex VIII, Chapter 1, 2.3(Annex V) and EN ISO 13485:2016 (excluding Design)
  • Audit of final inspection and testing (Annex VI) EN ISO 13485:2016 (excluding Design & Manufacture)
  • Audit of the full quality assurance system (Annex II) EN ISO 13485:2016

In short, Class Ir Reusable manufactures has to.

  • Upgrade existing Technical Files in line with MDR requirements with more details related to reuse, particularly cleaning, disinfection, sterilization, maintenance, functional testing, and the related instructions for use.
  • Clinical Evaluation and Risk Assessment documentation.
  • Issue a Declaration of Conformity.
  • EN ISO 13485:2016 Implementation.

We support class Ir Medical Device manufacturers with the following Services.

  1. Guidance & Technical File
  2. Identify test requirements and review the external reports.
  3. Arrange Notified Body and Coordinate with them till the issue of CE Certificate.
  4. Arrange EU Representative from Europe
  5. Arrange Free Sale Certificate from Europe.

Class IIa Medical Device is critical compared to class 1 devices. Self-declaration is legally not possible. Technical File should be submitted to the Notified Body, and conformity assessment by Notified Body is required before affixing CE Mark.

Possible Class IIa CE Certification options

  • Examination and testing of each product or homogenous batch of products (Annex IV)
  • Audit of the production quality assurance system (Annex V) EN ISO 13485:2012 (excluding Design)
  • Audit of final inspection and testing (Annex VI) EN ISO 13485:2012 (excluding Design & Manufacture)
  • Audit of the full quality assurance system (Annex II) EN ISO 13485:2012

We offer class IIa Medical Device, clients

  1. Guidance & Technical File
  2. Identify test requirements and review the external reports.
  3. Arrange Notified Body and Coordinate with them till the issue of CE Certificate.
  4. Arrange EU Representative from Europe
  5. Arrange Free Sale Certificate from Europe.

As per Medical Device Regulation (MDR), Class IIb Medical Device are critical. Design review and QMS implementation will be verified along with the technical file and Clinical Evaluation (meddev Rev 4) documents. Conformity assessment by a Notified Body is required before affixing CE Mark.

Possible Class 2b Medical Device CE Certification options

  • Type / Batch Examination and testing as per Annex IV
  • Onsite Audit of the production quality assurance system (Annex V) including Design
  • Audit of final inspection and testing (Annex VI) excluding Design & Manufacture
  • Audit of the full quality assurance system (Annex II) EN ISO 13485:2016

We support class IIb Device manufactures the following Services

  1. Guidance & Technical File
  2. Identify Biocompatablity test requirements and review the external Protocols and Reports.
  3. Prepare Clinical Evaluation Reports as per Meddev 2.7/1 Rev 4.
  4. Conduct Risk Analysis and prepare Risk Management Files as per EN ISO 14971.
  5. Arrange Notified Body and Coordinate with them till the issue of CE Certificate.
  6. Arrange EU Representative from Europe
  7. Periodic Safety Update Report.
  8. Arrange Free Sale Certificate from Europe.

CE Marking for Class 3 Medical Devices According to annexes II and III, the marking standards in MDR are far higher. This is where rigorous protocols will be implemented, owing to the fact that these devices pose the biggest danger to patients. According to MDR specifications, the majority of essential medical instruments are classified as Class 3. In comparison to other medical device manufacturers, all Class III medical device manufacturers must undergo rigorous performance and safety checks and clinical evaluation, as per the current MedDev 2.7.1 rev 4 guidelines.

Class III Medical Device manufactures have to submit technical documentation or file to the Notified Body for approval under Annex II and do not allow the Annex III / Annex VI option.

Definition & Examples for Class III Medical Devices

Class 3/111 follows the same guidelines as 1s, 2a, 2b, but also has to have Notified Body design Examination and Technical Documentation or Technical File review before affixing CE Logo on your medical device. Class III, at times, will be relied on to sustain human lives, so malfunctions are not acceptable in any manner. Some examples would be pacemakers, cerebral simulators, and heart valves, medicated bandages, etc.

Notified Body must carry out audit under Annex II full quality assurance system (EN ISO 13485:2016), plus that the manufacturer must submit the Technical File / Design Dossier to the Notified Body for approval under Annex II, for all type of Class III medical devices including medical devices with ancillary medicine.

(OR)

Type-examination (Annex 3) plus one of the two options given here:

  • Batch Inspection as per Annex IV
  • Audit of the production quality assurance system (Annex V) EN ISO 13485:2016 (with mandatory Design evaluation)

Need help in the Class III approval process?

  • Technical Documentation covering the following,
  • Risk Analysis,
  • Clinical Evaluation,
  • Post Market Surveillance,
  • Post Market Clinical Follow Up,
  • IFU /User Manual review
  • Notified Body Technical Documentation /Technical File clearance.

We support Medical Device manufacturers with the following Services:

  1. Guidance, Preparation, NB Submission, and Answering to Notified Body.
  2. Conduct Biological Evaluation.
  3. Review the external Protocols and Reports.
  4. Conduct Clinical Evaluation and Prepare Clinical Evaluation Reports as per Meddev 2.7/1 Rev 4.
  5. Conduct Risk Analysis and prepare Risk Management Files as per EN ISO 14971.
  6. Arrange Notified Body and Coordinate with them till the issue of CE Certificate.
  7. Arrange EU Representative from Europe.
  8. Arrange Free Sale Certificate from Europe.
  9. Development of Clinical Evaluation Report.
  10. Post Market Surveillance (PMS).
  11. Post Market Clinical Follow Up (PMCF).
  12. Periodic Safety Update Report (PSUR).

MDR Classifications examples

The Medical Device Regulation (MDR) classifies medical devices into different classes based on their inherent risks and intended use. Here are some examples of medical devices classified under different MDR classes:

Class I:

  1. Bandages and dressings
  2. Non-prescription contact lenses
  3. Dental floss
  4. Tongue depressors
  5. Surgical instruments for external use

Class IIa:

  1. Hearing aids
  2. Condoms
  3. Pregnancy test kits
  4. Nebulizers for local use
  5. Non-invasive blood pressure monitors

Class IIb:

  1. Infusion pumps
  2. Powered wheelchairs
  3. Electrocardiography (ECG) machines
  4. Surgical lasers
  5. Implantable contact lenses

Class III:

  1. Implantable pacemakers
  2. Heart valves
  3. Hip joint prostheses
  4. External defibrillators
  5. Active implantable medical devices

It’s important to note that these examples are just a small representation of the diverse range of medical devices that fall under each MDR class. The classification is based on multiple factors, including the device’s intended use, duration of contact with the body, and its potential for harm. Manufacturers must accurately determine the classification of their devices to ensure proper compliance with the MDR’s regulatory requirements.

How do you classify a medical device in Europe?

Classifying a medical device in Europe involves a systematic process that takes into account the device’s intended use, potential risks, and characteristics. The classification determines the regulatory requirements and level of scrutiny the device will be subjected to under the Medical Device Regulation (MDR). Here’s an overview of the steps involved in classifying a medical device in Europe:

Step 1: Understand Device Characteristics: Thoroughly analyze the device’s attributes, functionality, and intended purpose. Consider factors such as whether the device is invasive, its duration of contact with the body, its role in diagnosis or treatment, and the potential risks it poses to patients and users.

Step 2: Refer to Annex VIII of MDR: Annex VIII of the MDR contains detailed classification rules that outline the criteria for each class of medical device. These rules help manufacturers determine the appropriate class based on factors such as invasiveness, duration of contact, and impact on the body.

Step 3: Determine the Classification Rule: Using the information gathered in Step 1, match the device’s characteristics to the relevant classification rule in Annex VIII of the MDR. This will guide you toward the appropriate class for your device.

Step 4: Confirm the Classification: Once you’ve identified the relevant classification rule, confirm that it aligns with the device’s characteristics and intended use. If there is any uncertainty, consult with regulatory experts or competent authorities for clarification.

Step 5: Document the Classification Process: Maintain comprehensive documentation that outlines how you arrived at the classification for your device. This documentation will serve as evidence of compliance and support your regulatory submissions.

Step 6: Determine Conformity Assessment Route: Based on the determined class, identify the appropriate conformity assessment procedure that corresponds to the classification. Each class has specific requirements for conformity assessment, including the involvement of notified bodies for higher-risk devices.

Step 7: Prepare Technical Documentation: Compile detailed technical documentation that provides comprehensive information about the design, development, and manufacturing processes of the device. This documentation will be crucial in demonstrating compliance with regulatory requirements.

Step 8: Clinical Evaluation and Post-Market Surveillance: For higher-risk devices, conduct thorough clinical evaluations and establish effective post-market surveillance plans. These activities provide evidence of safety and performance throughout the device’s lifecycle.

Step 9: Declaration of Conformity and CE Marking: Once all requirements are met, issue a Declaration of Conformity affirming that your device complies with the MDR. This declaration is a prerequisite for affixing the CE mark on your device, indicating its compliance with EU regulations.

Step 10: Maintain Ongoing Compliance: Classifying a medical device is not a one-time process. Continuously monitor your device’s performance, update technical documentation as needed, and stay informed about any regulatory changes that could impact your device’s classification.

Navigating the classification process accurately is crucial to ensuring proper regulatory compliance and market access for your medical device within the European Union. It’s recommended to seek guidance from regulatory experts or competent authorities to ensure a thorough and accurate classification.