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Dynamic EU MDR 2017/745 Full Text
Chapter 1 (Art 1 - 4) Scope and definitions
Chapter 2 (Art 5 - 24) – Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement
Chapter 3 (Art 25 - 34) – Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices
Chapter 4 (Art 35 - 50) – Notified bodies
Chapter 5 (Art. 51 – 60) Classification and conformity assessment
Chapter 6 (Art. 61 – 82) Clinical evaluation and clinical investigations
Chapter 7 (Art. 83 – 100) Post-market surveillance, vigilance and market surveillance
Chapter 8 (Art. 101 – 108) Cooperation between member states, medical device coordination group, expert laboratories, expert panels and device registers
Chapter 9 (Art. 109 – 113) Confidentiality, data protection, funding and penalties
Chapter 10 (Art. 114 – 123) Final provisions
Annexes
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Chapter 5 (Art. 51 – 60) Classification and conformity assessment

Article 52 – Conformity assessment procedures

Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in
Annexes IX
⁠
to
XI
⁠
.
Prior to putting into service a device that is not placed on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in
Annexes IX
⁠
to
XI
⁠
.
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
⁠
.
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
⁠
, and including an assessment of the technical documentation as specified in Section 4 of that Annex of at least one representative device per generic device group.
However, 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.
Alternatively, 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
⁠
.
Where justified in view of well-established technologies, similar to those used in the exempted devices listed in the second subparagraph of paragraph 4 of this Article, being used in other class IIb implantable devices, or where justified in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission is empowered to adopt delegated acts in accordance with
Article 115
⁠
to amend that list by adding other types of class IIb implantable devices to that list or removing devices therefrom.
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.
Alternatively, 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.
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
⁠
. If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of
Annex IX
⁠
, or in Part A of
Annex XI
⁠
. However, the involvement of the notified body in those procedures shall be limited:
in the case of devices placed on the market in sterile condition, to the aspects relating to establishing, securing and maintaining sterile conditions;
in the case of devices with a measuring function, to the aspects relating to the conformity of the devices with the metrological requirements;
in the case of reusable surgical instruments, to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use.
Manufacturers of custom-made devices shall follow the procedure set out in
Annex XIII
⁠
and draw up the statement set out in Section 1 of that Annex before placing such devices on the market.
In addition to the procedure applicable pursuant to the first subparagraph, 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
⁠
.
In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7 of this Article, in the case of devices referred to in the first subparagraph of
Article 1(8)
⁠
, the procedure specified in Section 5.2 of
Annex IX
⁠
or Section 6 of
Annex X
⁠
, as applicable, shall also apply.
In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7 of this Article, in the case of devices that are covered by this Regulation in accordance with point (f) or (g) of
Article 1(6)
⁠
and with the first subparagraph of
Article 1(10)
⁠
, the procedure specified in Section 5.3 of
Annex IX
⁠
or Section 6 of
Annex X
⁠
, as applicable, shall also apply.
In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7, in the case of 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, the procedure specified in Section 5.4 of
Annex IX
⁠
or Section 6 of
Annex X
⁠
, as applicable, shall also apply.
The Member State in which the notified body is established may require that all or certain documents, including the technical documentation, audit, assessment and inspection reports, relating to the procedures referred to in paragraphs 1 to 7 and 9 to 11 be made available in an official Union language(s) determined by that Member State. In the absence of such requirement, those documents shall be available in any official Union language acceptable to the notified body.
Investigational devices shall be subject to the requirements set out in
Articles 62
⁠
to
81
⁠
.
The Commission may, by means of implementing acts, specify detailed arrangements and procedural aspects with a view to ensuring the harmonised application of the conformity assessment procedures by the notified bodies for any of the following aspects:
the frequency and the sampling basis of the assessment of the technical documentation on a representative basis as set out in the third paragraph of Section 2.3 and in Section 3.5 of
Annex IX
⁠
in the case of class IIa and class IIb devices, and in Section 10.2 of
Annex XI
⁠
in the case of class IIa devices;
the minimum frequency of unannounced on-site audits and sample tests to be conducted by notified bodies in accordance with Section 3.4 of
Annex IX
⁠
, taking into account the risk-class and the type of device;
the physical, laboratory or other tests to be carried out by notified bodies in the context of sample tests, assessment of the technical documentation and type examination in accordance with Sections 3.4 and 4.3 of
Annex IX
⁠
, Section 3 of
Annex X
⁠
and Section 15 of
Annex XI
⁠
.
The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in
Article 114(3)
⁠
.
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