EU routes to market for medical devices

The risk class of a device under Annex VIII to Regulation (EU) 2017/745 determines which conformity assessment procedure in Annexes IX to XI the manufacturer may use. Class I devices that are non-sterile, without a measuring function and not reusable surgical instruments are self-declared by the manufacturer. Every other class requires a notified body under a quality management system route, a type examination route or a product conformity verification route.¹

Article 52(1) and (2) require the manufacturer to complete the applicable conformity assessment before the device is placed on the market and, where a device is put into service without being placed on the market, before it is put into service.¹ Custom-made devices follow Annex XIII, with class III custom-made implantable devices also subject to Chapter I of Annex IX or Part A of Annex XI, and investigational devices are governed by Articles 62 to 81.¹

Requirements common to every route

A device may be placed on the market or put into service only if it complies with the Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose. It must meet the general safety and performance requirements in Annex I that apply to it, taking account of its intended purpose. Demonstration of conformity with those requirements includes a clinical evaluation under Article 61.¹ The Commission may adopt implementing acts to secure uniform application of Annex I where interpretation diverges.¹

Language is a national variable. The Member State in which the notified body is established may require that documents relating to the procedures in Article 52(1) to (7) and (9) to (11) be made available in an official Union language it determines. Where no such requirement exists, the documents are to be available in any official Union language acceptable to the notified body.¹

Class I

Manufacturers of class I devices other than custom-made or investigational devices declare conformity themselves. They draw up the technical documentation set out in Annexes II and III and issue the EU declaration of conformity referred to in Article 19.¹

Three subsets of class I require a notified body. Devices placed on the market in sterile condition, devices with a measuring function and reusable surgical instruments are subject to the procedures in Chapters I and III of Annex IX or in Part A of Annex XI. The notified body’s involvement is limited in each case. For sterile devices it covers the aspects relating to establishing, securing and maintaining sterile conditions. For measuring devices it covers conformity with the metrological requirements. For reusable surgical instruments it covers reuse.¹ That means in particular cleaning, disinfection, sterilization, maintenance and functional testing together with the related instructions for use.

Class IIa

Manufacturers of class IIa devices other than custom-made or investigational devices are subject to Chapters I and III of Annex IX. That includes an assessment of the technical documentation as specified in Section 4 of Annex IX for at least one representative device for each category of devices.¹

The alternative is to draw up the technical documentation in Annexes II and III together with a conformity assessment under Section 10 or Section 18 of Annex XI. Under that alternative the technical documentation assessment also applies to at least one representative device for each category of devices.¹

Class IIb

Manufacturers of class IIb devices other than custom-made or investigational devices are subject to Chapters I and III of Annex IX, with a Section 4 technical documentation assessment of at least one representative device per generic device group.¹ The unit of sampling differs from class IIa, where the unit is the category of devices.¹

For class IIb implantable devices the Section 4 assessment applies to every device. Two groups listed in the second subparagraph of Article 52(4) are excepted. Point (a) covers:

• sutures
• staples
• dental fillings
• dental braces
• tooth crowns
• screws
• wedges
• plates
• wires
• pins
• clips
• connectors

Point (b) covers:

• cannulas
• catheters
• feeding tubes
• suture pledgets
• suture sleeves
• suture buttons
• gastrostomy buttons
• bone wax
• bone fillers
• bone substitutes
• stem centralisers
• diaphyseal obturators
• radiography markers
• fiber ligatures
• transpalatal distractors
• nails
• anchors
• spinal posterior fixations
• textile braids
• dental implants
• orthodontic devices
• dental barriers
• suspensory fixations
• cinches

The Commission has the power under Article 52(5) to adopt delegated acts in accordance with Article 115 adding types to that list or removing them. It may do so where justified by well-established technologies similar to those in the listed devices being used in other class IIb implantable devices. It may also do so to protect the health and safety of patients, users or other persons, or other aspects of public health.¹

As an alternative to Annex IX, the manufacturer of a class IIb device may apply type examination under Annex X coupled with product conformity verification under Annex XI.¹

Class III

Manufacturers of class III devices other than custom-made or investigational devices are subject to the full Annex IX procedure, covering the quality management system and assessment of the technical documentation. The alternative is Annex X type examination coupled with Annex XI product conformity verification.¹ Class III carries no sampling concession of the kind available for class IIa and class IIb.¹

Additional procedures for particular device types

Three categories of device attract a further procedure on top of the one set by class. Each adds a consultation step under Section 5.2, 5.3 or 5.4 of Annex IX, or under Section 6 of Annex X where the type examination route is used.¹

Section 5.2 of Annex IX applies to devices referred to in the first subparagraph of Article 1(8). Section 5.3 applies to devices covered by the Regulation under point (f) or (g) of Article 1(6) and under the first subparagraph of Article 1(10). Section 5.4 applies to devices composed of substances or combinations of substances intended to be introduced into the human body via a body orifice or applied to the skin and absorbed by or locally dispersed in the human body.¹

Custom-made devices

Manufacturers of custom-made devices follow the procedure in Annex XIII and draw up the statement in Section 1 of that Annex before the device is placed on the market.¹ For class III custom-made implantable devices a notified body is also involved. Those manufacturers are additionally subject to the conformity assessment in Chapter I of Annex IX, or alternatively to Part A of Annex XI.¹

A derogation in Article 120(3f) allowed class III custom-made implantable devices to be placed on the market or put into service until 26 May 2026 without that certificate. It was conditional on a formal application lodged with a notified body under Section 4.3 of Annex VII no later than 26 May 2024 and a signed written agreement no later than 26 September 2024. That derogation has expired.¹

Devices made and used within a health institution

Devices manufactured and used within health institutions are treated as put into service.¹ Article 5(5) disapplies the requirements of the Regulation, other than the relevant general safety and performance requirements in Annex I, to devices manufactured and used only within health institutions established in the Union. All of the following conditions must be met:

• the devices are not transferred to another legal entity
• manufacture and use occur under appropriate quality management systems
• the health institution justifies in its documentation that the target patient group’s specific needs cannot be met, or cannot be met at the appropriate level of performance, by an equivalent device available on the market
• the health institution provides information on use to its competent authority on request, with a justification of manufacturing, modification and use
• the health institution draws up and publishes a declaration with its name and address, the details identifying the devices and a statement on compliance with Annex I
• the health institution draws up documentation sufficient for the competent authority to ascertain that Annex I is met
• the health institution ensures that devices are manufactured in accordance with that documentation
• the health institution reviews clinical experience and takes corrective action

Member States may require further information, may restrict the manufacture and use of specific types of such devices and may inspect the activities of health institutions. Article 5(5) does not apply to devices manufactured on an industrial scale.¹

Legacy certificates and the remaining transitional dates

Certificates issued under Directive 90/385/EEC or Directive 93/42/EEC from 25 May 2017 that were still valid on 26 May 2021 and have not been withdrawn remain valid until the dates in Article 120(3a).¹ Devices covered by such a certificate may be placed on the market or put into service until 31 December 2027 for all class III devices and for class IIb implantable devices other than those in the point (a) list above. The date is 31 December 2028 for other class IIb devices, for class IIa devices and for class I devices placed on the market in sterile condition or having a measuring function.¹

Some devices required no notified body for conformity assessment under Directive 93/42/EEC and had a declaration of conformity drawn up before 26 May 2021. Where such devices now require notified body involvement, they may be placed on the market until 31 December 2028.¹

Those extensions depend on the conditions in Article 120(3c). The device must continue to comply with the applicable Directive, must show no significant change in design or intended purpose and must present no unacceptable risk. A quality management system under Article 10(9) had to be in place no later than 26 May 2024. A formal application to a notified body had to be lodged by 26 May 2024 and a written agreement signed by 26 September 2024.¹ Post-market surveillance, market surveillance, vigilance and registration of economic operators and devices follow the Regulation for these devices rather than the Directives.¹

Devices lawfully placed on the market under the Directives before 26 May 2021, and those placed on the market under the transitional provisions, may continue to be made available or put into service.¹

Questions people also ask

Does a class IIa device always need a notified body?

Yes. A class IIa device other than a custom-made or investigational device requires either Chapters I and III of Annex IX with a Section 4 technical documentation assessment, or Annexes II and III technical documentation coupled with Section 10 or Section 18 of Annex XI. In both cases the technical documentation assessment covers at least one representative device for each category of devices.¹

When must a notified body assess the technical documentation of every class IIb implantable device?

The Section 4 assessment applies device by device for class IIb implantable devices, except for the two groups listed in the second subparagraph of Article 52(4). Those cover items such as sutures, staples, screws and plates in point (a) and items such as cannulas, catheters, dental implants and orthodontic devices in point (b). For other class IIb devices the assessment covers at least one representative device per generic device group.¹

What is the deadline for devices still relying on a Medical Device Directive certificate?

Article 120(3a) sets 31 December 2027 for class III devices and for class IIb implantable devices outside the exempt list, and 31 December 2028 for other class IIb devices, class IIa devices and sterile or measuring class I devices. Those dates apply only where the conditions in Article 120(3c) are satisfied, including the application and agreement deadlines that fell in 2024.¹

Is a self-declared class I device free of any notified body involvement?

A class I device that is placed on the market in sterile condition, has a measuring function or is a reusable surgical instrument requires a notified body under Chapters I and III of Annex IX or Part A of Annex XI. The notified body’s role is confined to sterility, to metrological conformity or to the reuse aspects respectively. All other class I devices are declared by the manufacturer after the Annexes II and III technical documentation is drawn up.¹

Does a device containing a medicinal substance follow a different route?

The class-based procedure still applies. Article 52(9) adds the procedure in Section 5.2 of Annex IX, or Section 6 of Annex X where type examination is used, for devices referred to in the first subparagraph of Article 1(8). Comparable additions apply under Article 52(10) and Article 52(11) for other specified device types.¹

Footnotes

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Consolidated version of 2026-07-19. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20260719 ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰ ↩¹¹ ↩¹² ↩¹³ ↩¹⁴ ↩¹⁵ ↩¹⁶ ↩¹⁷ ↩¹⁸ ↩¹⁹ ↩²⁰ ↩²¹ ↩²² ↩²³ ↩²⁴ ↩²⁵ ↩²⁶ ↩²⁷ ↩²⁸ ↩²⁹ ↩³⁰ ↩³¹ ↩³² ↩³³ ↩³⁴