What an EU medical device submission contains

An EU medical device submission is the technical documentation set out in Annex II and Annex III of Regulation (EU) 2017/745, assessed under the conformity assessment procedure that Article 52 attaches to the device’s risk class. That documentation is presented to a notified body under Annex IX, Annex X or Annex XI. This applies to all classes except class I devices outside the sterile, measuring and reusable surgical instrument categories, custom-made devices under Annex XIII and investigational devices under Articles 62 to 81. For those class I devices the manufacturer draws up the same Annex II and Annex III documentation and issues the EU declaration of conformity referred to in Article 19 on its own responsibility.¹

The Annex II technical documentation

Annex II fixes the content of the core file. The manufacturer draws it up for every device, whatever the class, and the notified body assesses it where one is involved. Annex II is organised in six numbered headings.

• Device description and specification, including variants and accessories, and a reference to previous and similar generations of the device.
• Information supplied by the manufacturer, meaning the complete set of labels and instructions for use in the languages accepted in the Member States where the device is to be sold.
• Design and manufacturing information, including the manufacturing processes and their validation, and identification of all sites including suppliers and sub-contractors.
• Demonstration of conformity with the general safety and performance requirements of Annex I.
• The benefit-risk analysis and the results of risk management.
• Product verification and validation, covering pre-clinical and clinical data.

Section 1.1 is granular. It calls for the intended purpose and intended users and the Basic UDI-DI referred to in Part C of Annex VI. It also calls for the intended patient population and the indications, contra-indications and warnings. It also calls for the principles of operation, the rationale for qualification of the product as a device, the risk class with a justification of the classification rule applied under Annex VIII and an explanation of any novel features.¹

Section 4 sets the structure of the conformity demonstration. The file states which general safety and performance requirements apply. It gives the reason for the exclusion of each requirement that does not apply. It also gives the method used to demonstrate conformity with each applicable requirement, the harmonised standards, common specifications or other solutions applied, and the precise identity of the controlled documents that evidence conformity. The information on the controlled documents carries a cross-reference to the location of that evidence within the full technical documentation and, where applicable, the summary technical documentation.¹

Section 6 holds the evidence itself. Pre-clinical data covers the following.

• biocompatibility
• physical, chemical and microbiological characterisation
• electrical safety and electromagnetic compatibility
• software verification and validation
• stability including shelf life
• performance and safety

Test design, complete protocols and methods of data analysis are included alongside the summaries and conclusions. Where no new testing has been undertaken, the documentation carries a rationale for that decision. Section 6.1 also requires the clinical evaluation report with its updates, the clinical evaluation plan referred to in Article 61(12) and Part A of Annex XIV, and the post-market clinical follow-up plan and evaluation report under Part B of Annex XIV or a justification of why post-market clinical follow-up is not applicable.¹

Section 6.2 adds content for particular device types. Devices incorporating a medicinal substance and devices using tissues or cells of human or animal origin require a statement of that fact together with defined data. Devices composed of substances absorbed by or locally dispersed in the body require detailed information on absorption, local tolerance and toxicity studies. Devices containing CMR or endocrine-disrupting substances require the justification referred to in Section 10.4.2 of Annex I. Sterile devices require a description of the environmental conditions for the relevant manufacturing steps and validation reports covering packaging, sterilisation and maintenance of sterility, addressing bioburden testing, pyrogen testing and sterilant residues where applicable.¹

The Annex III post-market surveillance documentation

Annex III is a second body of technical documentation, drawn up in accordance with Articles 83 to 86. It contains the post-market surveillance plan, the periodic safety update report referred to in Article 86 and the post-market surveillance report referred to in Article 85.¹

The plan addresses the collection and use of the following.

• information on serious incidents and field safety corrective actions
• records of non-serious incidents and undesirable side-effects
• trend reporting
• technical literature and registers
• feedback and complaints from users, distributors and importers
• publicly available information on similar devices

It sets out the process for collecting that information, the methods for assessing it, and suitable indicators and threshold values for continuous reassessment of the benefit-risk analysis. It also sets out the methods and protocols for trend reporting under Article 88, including how a statistically significant increase in frequency or severity of incidents is established and the observation period. The post-market clinical follow-up plan under Part B of Annex XIV sits inside the Annex III plan, or a justification of its non-applicability does.¹

Which procedure applies by class

Article 52 assigns the route. Manufacturers of class III devices other than custom-made and investigational devices undergo conformity assessment under Annex IX, or alternatively type examination under Annex X coupled with product conformity verification under Annex XI. Manufacturers of class IIb devices apply Chapters I and III of Annex IX with assessment of the technical documentation under Section 4 of that Annex for at least one representative device per generic device group, or the Annex X and Annex XI combination.¹

For class IIb implantable devices the Section 4 technical documentation assessment applies to every device, with two groups of exceptions set out in the second subparagraph of Article 52(4).

• The first group is as follows.
  • sutures
  • staples
  • dental fillings
  • dental braces
  • tooth crowns
  • screws
  • wedges
  • plates
  • wires
  • pins
  • clips
  • connectors
• The second group is as follows.
  • 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 may amend that list by delegated act under Article 115, in either direction.¹

Class IIa manufacturers apply Chapters I and III of Annex IX with a Section 4 technical documentation assessment of at least one representative device for each category of devices. The alternative is the Annex II and Annex III documentation coupled with Section 10 or Section 18 of Annex XI, again with assessment of a representative device per category. Class I devices placed on the market in sterile condition, having a measuring function or being reusable surgical instruments require Chapters I and III of Annex IX or Part A of Annex XI. In those three cases the notified body’s involvement is limited to sterility, to metrological conformity, and to reuse aspects such as cleaning, disinfection, sterilization, maintenance and functional testing.¹

Custom-made devices follow Annex XIII with the statement in Section 1 of that Annex. Class III custom-made implantable devices additionally undergo assessment under Chapter I of Annex IX or Part A of Annex XI. Investigational devices are subject to Articles 62 to 81.¹

Additional procedures for specific devices

Three categories trigger a further step on top of the class-based route. Devices incorporating a medicinal substance under the first subparagraph of Article 1(8) trigger Section 5.2 of Annex IX or Section 6 of Annex X. Devices covered by point (f) or (g) of Article 1(6) and by the first subparagraph of Article 1(10) trigger Section 5.3 of Annex IX or Section 6 of Annex X. Devices composed of substances introduced via a body orifice or applied to the skin and absorbed or locally dispersed trigger Section 5.4 of Annex IX or Section 6 of Annex X.¹

Format and language

Annex II requires the technical documentation and any summary of it to be presented in a clear, organised and readily searchable manner. Annex III sets the same presentation requirement for the post-market surveillance documentation.¹ Neither Annex prescribes a form or an electronic template.¹

Language is set by the Member State in which the notified body is established. That Member State may require all or certain documents to be made available in official Union languages it determines. This covers the technical documentation and the audit, assessment and inspection reports. Absent such a requirement, the documents are available in any official Union language acceptable to the notified body.¹

What review consists of

Review under Annex IX combines a quality management system assessment with assessment of the technical documentation, as the Annex title indicates. Article 52(14) identifies the elements the Commission may harmonise by implementing act, adopted under the examination procedure in Article 114(3), and in doing so names the operative review mechanics.

• The frequency and sampling basis of representative technical documentation assessment under the third paragraph of Section 2.3 and Section 3.5 of Annex IX for class IIa and class IIb devices, and under Section 10.2 of Annex XI for class IIa devices.
• The minimum frequency of unannounced on-site audits and sample tests under Section 3.4 of Annex IX, by risk class and device type.
• The physical, laboratory or other tests carried out by notified bodies for sample tests, technical documentation assessment and type examination. These are set out in Sections 3.4 and 4.3 of Annex IX, Section 3 of Annex X and Section 15 of Annex XI.¹

Certificates issued by a notified body are the subject of Annex XII.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 were not later withdrawn remain valid beyond the period printed on them, until the dates in Article 120(3a). Those dates are 31 December 2027 for all class III devices and for class IIb implantable devices other than the types listed in point (a), and 31 December 2028 for other class IIb devices, class IIa devices and class I devices placed on the market in sterile condition or with a measuring function. Devices that did not require notified body involvement under Directive 93/42/EEC but do under the Regulation, with a declaration of conformity drawn up before 26 May 2021, may be placed on the market until 31 December 2028.¹

Those extensions depend on the conditions in Article 120(3c). The device continues to comply with the applicable Directive, there are no significant changes in design and intended purpose, and the device presents no unacceptable risk. The manufacturer had to have a quality management system in place under Article 10(9) by 26 May 2024 and to have lodged a formal application with a notified body under Section 4.3 of Annex VII by that date, with a signed written agreement by 26 September 2024. Post-market surveillance, market surveillance, vigilance and registration requirements of the Regulation apply to these devices in place of the corresponding Directive requirements.¹

Article 120(3f) allowed class III custom-made implantable devices to be placed on the market without a notified body certificate until 26 May 2026, on the same application and agreement conditions. That date has passed.¹

Registration timing under Article 123

The obligations tied to the Eudamed electronic systems in Article 33(2) apply from six months after publication of the notice under Article 34(3) confirming that the relevant system is functional. Article 123(3)(e) then gives manufacturers twelve months from that publication to enter the Article 29 registration information for devices assessed under Article 52 and for legacy devices placed on the market under Article 120(3), (3a) or (3b). Notified bodies have eighteen months from publication of the corresponding notice to enter certificate information under Article 56(5).¹

UDI carrier obligations under Article 27(4) applied from 26 May 2021 for implantable and class III devices, from 26 May 2023 for class IIa and class IIb devices and from 26 May 2025 for class I devices. For reusable devices required to bear the carrier on the device itself, Article 27(4) applies from 26 May 2023 for implantable and class III devices and from 26 May 2025 for class IIa and class IIb devices, and it applies to class I devices only from 26 May 2027.¹

Questions people also ask

Is an EU device dossier submitted to a government regulator?

Under Article 52 the manufacturer undertakes the conformity assessment in accordance with Annexes IX to XI before the device is placed on the market or put into service. For all classes above the self-declared class I devices, that assessment involves a notified body. Article 52(12) treats the notified body as the recipient of the technical documentation, audit, assessment and inspection reports, with language determined by the Member State in which the notified body is established.¹

Does a class I device require any technical documentation?

Yes. Article 52(7) requires manufacturers of class I devices other than custom-made and investigational devices to draw up the technical documentation set out in Annexes II and III before issuing the EU declaration of conformity under Article 19. Where the device is sterile, has a measuring function or is a reusable surgical instrument, a notified body is involved on that limited aspect only.¹

How often does a notified body assess the technical documentation for class IIa and class IIb devices?

Article 52 requires a Section 4 Annex IX assessment of at least one representative device per generic device group for class IIb, and of at least one representative device per category of devices for class IIa. For class IIb implantable devices the assessment covers every device, except the types listed in the second subparagraph of Article 52(4). Article 52(14)(a) allows the Commission to specify the frequency and sampling basis by implementing act.¹

What has to be in a post-market surveillance plan?

Annex III requires the plan to describe a proactive and systematic collection process, methods to assess the data, and indicators and threshold values for reassessing the benefit-risk analysis. It also requires methods for investigating complaints and protocols for trend reporting under Article 88. Further required are procedures for communicating with competent authorities and economic operators and tools to trace devices needing corrective action. The post-market clinical follow-up plan under Part B of Annex XIV forms part of it.¹

Can a device still be sold on an old Directive certificate?

Yes, within limits. Article 120(3a) permits placing on the market until 31 December 2027 for class III devices and most class IIb implantable devices, and until 31 December 2028 for other class IIb, class IIa and sterile or measuring class I devices. The conditions in Article 120(3c) include the quality management system and notified body application deadlines that fell in 2024.¹

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