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Types of MDR Technical Files

SR. NO.

TECHNICAL FILE TYPE

RULES APPLIED

CONFORMITY ROUTE

CLASS I

1.

CLASS I

Non-Invasive Device

Rule-1 All Non-Invasive device are classified as class IConformity Assessment Article 52 (7). Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III.

Notified Body involvement is not mandatory.

CE mark could be affixed by self-Declaration

Rule 2 -All non-invasive devices not intended for channeling or storing blood, liquids or gases, body liquid for storing organs, parts of organs or body cells and tissues.
Rule 4 – All non-invasive devices which come into contact with injured skin or mucous membrane if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates.

2.

CLASS I

Invasive Device

Rule 5 – All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class I active device are Class I if they are intended for transient use (Transient’ means normally intended for continuous use for less than 60 minutes.)
Rule 5- Device used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane

3.

CLASS I

Active device

Rule 10 – Active devices intended to illuminate the patient’s body, in the visible spectrum, in which case they are classified as class I
Rule 11- All other software is classified as class I, other than those mentioned under Class IIa, Class IIb, and Class III active device.
Rule 13- All other active devices are classified as class I.

4.

Class I

Sterile and

Measuring Device

Article 52 (Point 7)Conformity Assessment Article 52 (7). For Reusable Surgical Instruments the manufacturer shall apply CA as per the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI.

The involvement of the notified body in below cases:

(a)  in the case of devices placed on the market in sterile condition, to the aspects relating to establishing, securing and maintaining sterile conditions.

(b)  in the case of devices with a measuring function, to the aspects relating to the conformity of the devices with the metrological requirements.

-For Sterile medical device CE marking, Notified-body involvement is mandatory, and device must comply with Quality Management System.

– For Measuring device those are supplied in sterile condition require notified body certification, non-sterile device don’t require notified body involvement.

5.

CLASS I

Surgical Invasive Device

Rule 6 – All surgically invasive devices intended for transient use are reusable surgical instrumentsConformity Assessment Article 52 (7). For Reusable Surgical Instruments the manufacturer shall apply CA as per the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI.

The involvement of the notified body in the case of reusable surgical instruments, to the aspects relating to the reuse of the device, cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use.

Class IIa

6.

CLASS IIa

Non-Invasive Device

Rule 2 -All non-invasive devices intended for channeling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:Conformity Assessment Article 52 (6). Manufacturers of class IIa devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Section 4 of that Annex of at least one representative device for each category of devices.

OR

The manufacturer may choose to draw up the technical documentation set out in Annexes II and III coupled with a conformity assessment as specified in Section 10 or Section 18 of Annex XI. The assessment of the technical documentation shall apply for at least one representative device for each category of devices.

Declaration of Conformity with a Notified body assessment before affixing CE mark

Rule 3-All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended, the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat
Rule 4- All non-invasive devices which meet injured skin or mucous membrane if they are principally intended to manage the micro-environment of injured skin or mucous membrane

7.

CLASS IIa

Invasive Device

Rule 5- All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class I active device are class IIa if they are intended for short-term use (Short term’ means normally intended for continuous use for between 60 minutes and 30 days)
Rule -5 Device used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are classified as class IIa
Rule 5 -All invasive devices with respect to body orifices, other than surgically invasive devices that are intended for connection to a class IIa, class IIb or class III active device, are classified as class IIa.

8.

CLASS IIa

Surgical Invasive Device

Rule 6- All surgically invasive devices intended for transient use are classified as class IIa
Rule 7 – All surgically invasive devices intended for short-term use are classified as class IIa (Short term’ means normally intended for continuous use for between 60 minutes and 30 days)

9.

CLASS IIa

Implantable device & Long Term Surgical Invasive Device

Rule 8- All implantable devices and long-term surgically invasive devices intended to be placed in the teeth.

10.

CLASS IIa

Active Therapeutic Device

Rule 9- All active therapeutic devices intended to administer, or exchange energy are classified as class IIa

11.

CLASS IIa

Active Device

Rule 10 – Active devices intended for diagnosis and monitoring are as class IIa

Rule 10 Active devices if they are intended to supply energy which will be absorbed by the human body

Rule 10 Active devices if they are intended to image in vivo distribution of radiopharmaceuticals.

Rule 10 Active devices intended to allow direct diagnosis or monitoring of vital physiological processes

Rule 11-Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is class IIa,

Rule 11- Software intended to monitor physiological processes is classified as class IIa

Rule 12- All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body are classified as class IIa

12.

CLASS IIa

Special Case

Rule 16- All devices intended specifically to be used for disinfecting or sterilizing medical devices are classified as class IIa
Rule 17- Devices specifically intended for recording of diagnostic images generated by X-ray radiation are classified as class IIa
Rule 19 – All devices incorporating or consisting of nanomaterial are class IIa if they present a negligible potential for internal exposure.
Rule 20 – All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation are classified as class IIa
Rule 21- Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and

that are absorbed by or locally dispersed in the human body are classified as class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities

CLASS IIb

13.

CLASS IIb

Non-Invasive Device

Rule 2-Non-Invasive – Blood bags
Rule 3 All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIbConformity Assessment Article 52 (4). Manufacturers of class IIb devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, with assessment of the technical documentation as specified in Section 4 of that Annex of at least one representative device per generic device group

OR

The manufacturer may choose to apply a conformity assessment based on type examination as specified in Annex X coupled with a conformity assessment based on product conformity verification as specified in Annex XI.

Article 61:-For all the class IIb devices referred to in point (b) of Article 54(1), the manufacturer may, prior to its clinical evaluation and/or investigation, consult an expert panel as referred to in Article 106, with the aim of reviewing the manufacturer’s intended clinical development strategy and proposals for clinical investigation. The manufacturer shall give due consideration to the views expressed by the expert panel.

Conformity Assessments is required before affixing CE marking by Notified Body. Review of QMS implementation, Technical file, Clinical Evaluation, Design review by notified body.

Rule 4 All non-invasive devices which meet injured skin or mucous membrane if they are intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent.

14.

CLASS IIb

Invasive device

Rule 6- All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for Connection to an active device or which are intended for connection to a class I active device are Class IIb if they are intended for long-term use (‘Long term’ means normally intended for continuous use for more than 30 days.)

15.

CLASS IIb

Surgical Invasive device

Rule 6 All surgically invasive devices intended to supply energy in the form of ionizing radiation in which case they are classified as class IIb.

Rule 6- All surgically invasive devices have a biological effect or are wholly or mainly absorbed are classified as class IIb

Rule 6- All surgically invasive devices intended to administer medicinal products by means of a delivery system, if such administration of a medicinal product is done in a manner that is potentially hazardous taking account of the mode of application are class IIb.

Rule 7 – All surgically invasive devices intended to supply energy in the form of ionizing radiation

Rule 7 – All surgically invasive devices intended to administer medicines,

Rule 7 – All surgically invasive devices intended to undergo chemical change in the body, except if the devices are placed in the teeth

16.

CLASS IIb

Active Therapeutic Device

Rule-9 All active therapeutic devices that they may administer energy to or exchange energy with the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy are class IIb.

17.

CLASS IIb

Active Device

Rule 9-All active devices intended to control or monitor the performance of active therapeutic class IIb devices or intended directly to influence the performance of such devices are classified as class IIb.

Rule 9- All active devices intended to emit ionizing radiation for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb.

Rule 10 – Active devices intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system, or they are intended for diagnosis in clinical situations where the patient is in immediate danger, in which cases they are classified as class IIb.

Rule 10 – Active devices intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology, including interventional radiology devices and devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb.

Rule 11- Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes that may impact a serious deterioration of a person’s state of health or a surgical intervention, it is classified as class IIb.

Rule 11- Software intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.

Rule 12- All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are classified as class IIb.

18.

CLASS IIb

Special Rules

Rule 15- All devices used for contraception or prevention of the transmission of sexually transmitted diseases are classified as class IIb
Rule 16- All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses are classified as class IIb

Rule 16- disinfecting solutions or washer-disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are classified as class IIb.

Rule 19 – All devices incorporating or consisting of nanomaterial if they present a low potential for internal exposure
Rule 20 – All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation, unless their mode of action has an essential impact on the efficacy and safety of the administered medicinal product or they are intended to treat life- threatening conditions, are classified as class IIb
Rule 21- Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified as class IIb in all other cases except then those specified in Class III, Class IIA Special case

19.

CLASS IIb

Implantable device & Long Term Surgical Invasive Device

Rule 8- All implantable devices and long-term surgically invasive devices are classified as class IIb (‘Long term’ means normally intended for continuous use for more than 30 days.)Conformity Assessment Article 52 (4). For class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, the assessment of the technical documentation as specified in Section 4 of Annex IX shall apply for every device.

CLASS III

20.

CLASS III- Non-Invasive Device

Rule 3- All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body.Conformity Assessment: – Article 52 (3) Manufacturers of class III devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Annex IX. Alternatively, the manufacturer may choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI.

Notified body review device design, technical file as per Annex II before affixing CE logo.

Article 61(2)- For all class III devices referred to in point (b) of Article 54(1), the manufacturer may, prior to its clinical evaluation and/or investigation, consult an expert panel as referred to in Article 106, with the aim of reviewing the manufacturer’s intended clinical development strategy and proposals for clinical investigation. The manufacturer shall give due consideration to the views expressed by the expert panel.

21.

CLASS III Surgical Invasive Device

Rule 6- All surgically invasive devices are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III;

Rule 6- All surgically invasive devices are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III

Rule 7 – All surgically invasive devices intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body

Rule 7 – All surgically invasive devices intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system

Rule 7 – All surgically invasive devices having a biological effect or are wholly or mainly absorbed are classified as class III

22.

Class III

Implantable device & Long Term Surgical Invasive Device

Rule 8 – All implantable devices and long-term surgically invasive devices are class III if:

1) intended to be used in direct contact with the heart, the central circulatory system or the central nervous system

2) have a biological effect or are wholly or mainly absorbed

3) are intended to undergo chemical change in the body, except if the devices are placed in the teeth.

4) are intended to administer medicinal products,

5) are active implantable devices or their accessories

6) are breast implants or surgical meshes,

7) are total or partial joint replacements, with the exception of ancillary components such as screws, wedges, plates and instruments

8) are spinal disc replacement implants or are implantable devices that meet the spinal column, with the exception of components such as screws, wedges, plates and instruments.

23.

Class III

Active Device

Rule 9- All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable devices are classified as class III.
Rule 11-Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes have an impact that may cause death or an irreversible deterioration of a person’s state of health, in which case it is in class III;

24.

Class III

Special Rules

Rule 14-. All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, including a medicinal product derived from human blood or human plasma, and that has an action ancillary to that of the devices, are classified as class III.
Rule 15 – Devices used for contraception or prevention of the transmission of sexually transmitted diseases that are implantable or long-term invasive devices are classified as class III.
Rule 18 – All devices manufactured utilizing tissues or cells of human or animal origin, or their derivatives, which are non- viable or rendered non-viable, are classified as class III unless devices intended to come into contact with intact skin only.
Rule 19 – All devices incorporating or consisting of nanomaterial if they present a high or medium potential for internal exposure
Rule 21- Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are class III if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose.

Rule 21- Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body;

Rule 22- Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators, are class III.

25.

Systems and procedure packs

Article 22

Systems: – ‘system’ means a combination of products, either packaged together or not, which are intended to be inter- connected or combined to achieve a specific medical purpose.

Procedure Packs: – ‘procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose;

Para1. Natural or legal persons shall draw up a statement if they combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack:

(a)  other devices bearing the CE marking.

(b)  in vitro diagnostic medical devices bearing the CE marking in conformity with Regulation (EU) 2017/746.

(c)  other products which are in conformity with legislation that applies to those products only where they are used within a medical procedure or their presence in the system or procedure pack is otherwise justified.

Para 2: In the statement made pursuant to paragraph 1, the natural or legal person concerned shall declare that:

(a) they verified the mutual compatibility of the devices and, if applicable other products, in accordance with the manufacturers’ instructions and have carried out their activities in accordance with those instructions.

(b)  they packaged the system or procedure pack and supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products which have been put together.

(c)  the activity of combining devices and, if applicable, other products as a system or procedure pack was subject to appropriate methods of internal monitoring, verification and validation.

Article shall be kept at the disposal of the competent authorities, after the system or procedure pack has been put together, for the period that is applicable under Article 10(8) to the devices that have been combined. Where those periods differ, the longest period shall apply.

The systems or procedure packs referred to in paragraph 1 of this Article shall not themselves bear an additional CE marking but they shall bear the name, registered trade name or registered trade mark of the person referred to in paragraphs 1 and 3 of this Article as well as the address at which that person can be contacted, so that the person’s location can be established.

Para 3: – Any natural or legal person who sterilizes systems or procedure packs referred to in paragraph 1 for the purpose of placing them in the market shall,At their choice, apply one of the procedures set out in Annex IX or the procedure set out in Part A of Annex XI. The application of those procedures and the involvement of the notified body shall be limited to the aspects of the procedure relating to ensuring sterility until the sterile packaging is opened or damaged. The natural or legal person shall draw up a statement declaring that sterilization has been carried out in accordance with the manufacturer’s instructions
Para4:-Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, or where the sterilizations has not been carried out in accordance with the manufacturer’s instructions.The system or procedure pack shall be treated as a device and shall be subject to the relevant conformity assessment procedure pursuant to Article 52. The natural or legal person shall assume the obligations incumbent on manufacturers.

26.

Custom Made Device

ANNEX XIII of EU MDR 2017/745Authorized representative shall draw up a statement specified in section 1 of Annex XIII

Conformity Assessment: – Article 52 (8) Manufacturers of class III custom-made implantable devices shall be subject to the conformity assessment as specified in Chapter I of Annex IX. Alternatively, the manufacturer may choose to apply a conformity assessment as specified in Part A of Annex XI.

27.

Investigational devices

Follow requirements set out in Article 62 to 81