MDR class IIb and III: routes, CECP, PSUR, EUDAMED

Hugues Orgitello updated 7 Oct 2026 20 min read

This page is the in-depth companion to the MDR overview at /en/guides/mdr-medical-device-regulation/. It reads Regulation (EU) 2017/745 in its consolidated version of July 19, 2026, which includes the two delegated regulations of March 20, 2026 that widened the well-established technology lists, and it checks every date, article and annex section the page cites. It focuses on class IIb and class III, where notified-body involvement is heaviest, and it ends with the claims the texts contradict, several of which this page used to make.

What changed for class IIb and III, 2023 to 2027

Date	Act or event	Effect for class IIb and III
March 20, 2023	Regulation (EU) 2023/607 published	Article 120(3a): MDD and AIMDD devices may be placed on the market until December 31, 2027 (class III, class IIb implantable devices outside the well-established list) or December 31, 2028 (other classes), under the conditions of Article 120(3c)
May 26, 2024	Article 120(3c)(d) and (e) deadline	Quality management system in place and formal application lodged with an MDR notified body
September 26, 2024	Article 120(3c)(e) deadline	Written agreement signed with the notified body
January 10, 2025	Article 10a applies (Regulation (EU) 2024/1860)	At least 6 months notice to the competent authority and direct customers before an interruption or discontinuation of supply that could cause serious harm
November 27, 2025	Decision (EU) 2025/2371 published	Four EUDAMED electronic systems declared functional: Actors, UDI and devices, Notified bodies and certificates, Market surveillance
December 16, 2025	Commission proposal COM(2025) 1023	Proposed simplification of the MDR and IVDR; not adopted law (see below)
May 26, 2026	End of Article 120(3f)	Class III custom-made implantable devices can no longer rely on the derogation from the notified body certificate
May 28, 2026	Six months after the notice (Article 123(3)(d))	The four modules are mandatory to use
June 17, 2026	Decision (EU) 2026/1231 published	EN 60601-1:2006 with A13:2024 cited as entry 65 of the MDR list of harmonised standards
July 19, 2026	Delegated Regulations (EU) 2026/1359 and 2026/1451 in force (published June 29, 2026)	Longer lists of class IIb implantable devices exempted from per-device assessment (Article 52(4)) and of devices exempted from clinical investigations (Article 61(6)(b))
November 2026	12 months after the notice (Article 123(3)(e))	Devices placed on the market from May 28, 2026, including legacy devices, must be registered in EUDAMED
May 2027	18 months after the notice (Article 123(3)(ea))	Notified bodies must have entered the latest relevant certificates in EUDAMED
December 31, 2027	Article 120(3a)(a)	Last day for placing MDD-certified class III and class IIb implantable devices on the market
December 31, 2028	Article 120(3a)(b) and (3b)	Last day for the other legacy classes

Conformity assessment routes, article by article

The routes are assigned class by class in Article 52. The table below quotes what each paragraph requires, which is narrower than the usual summaries.

Class	Article	Default route	Alternative	Technical documentation assessment
Class III	52(3)	Annex IX (Chapters I, II, III)	Annex X coupled with Annex XI	Every device (Annex IX Section 4)
Class IIb implantable, not on the exempt list	52(4), second subparagraph	Annex IX Chapters I and III plus Section 4	Annex X coupled with Annex XI	Every device
Class IIb implantable on the exempt list	52(4) as amended by 2026/1359	Annex IX Chapters I and III plus Section 4	Annex X coupled with Annex XI	At least one representative device per generic device group
Class IIb non-implantable	52(4), first subparagraph	Annex IX Chapters I and III plus Section 4	Annex X coupled with Annex XI	At least one representative device per generic device group
Class III custom-made implantable	52(8)	Annex XIII plus Annex IX Chapter I	Annex XIII plus Annex XI Part A	Not applicable

Additional procedures stack on top of the route: consultation of a medicines authority for devices incorporating a medicinal substance (Annex IX Section 5.2, Article 52(9)), devices manufactured using tissues or cells of human or animal origin (Section 5.3, Article 52(10)), and devices composed of substances absorbed by or locally dispersed in the body (Section 5.4, Article 52(11)). For the medicinal substance consultation, the medicines authority gives its opinion within 210 days of receiving all the necessary documentation (Section 5.2).

Whatever the route, Article 10(9) requires every manufacturer to have a quality management system. Annex X does not let a manufacturer skip one.

The 2026 well-established technology lists

Two delegated regulations dated March 20, 2026 used the powers in Article 52(5) and Article 61(8). They are often read as one list; they are two different lists with two different effects.

	Delegated Regulation (EU) 2026/1359	Delegated Regulation (EU) 2026/1451
Provision amended	Article 52(4), second subparagraph	Article 61(6)(b)
Effect	Class IIb implantable devices exempted from the technical documentation assessment of every device	Implantable and class III devices exempted from the obligation to perform clinical investigations
Original list kept as point (a)	Sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, connectors	Same twelve types
Examples added in point (b)	Cannulas, catheters, feeding tubes, suture pledgets, sleeves and buttons, gastrostomy buttons, bone wax, bone fillers, bone substitutes, stem centralisers, nails, anchors, spinal posterior fixations, dental implants, orthodontic devices, dental barriers, suspensory fixations and cinches	Almost all of the 2026/1359 additions (catheters only in named forms, such as anticoagulant-coated catheters and port catheters) plus, among others, cranial perforators, introducers, dilators, ventricular drains, guide wires, pacing wires and leads, embolisation coils, embolisation particles, shunts, reusable surgical instruments and internal defibrillation paddles
Condition kept	None beyond the list	Clinical evaluation based on sufficient clinical data and compliant with any relevant product-specific common specification

The exemption from clinical investigations does not remove the clinical evaluation: Article 61(1) and Annex XIV Part A still apply, and Article 61(7) requires the manufacturer and the notified body to justify the use of the exemption in the clinical evaluation report and in the clinical evaluation assessment report.

Software: Rule 11 decides the class

For medical device software, Rule 11 of Annex VIII (Section 6.3) places software that provides information used for diagnostic or therapeutic decisions in class IIa, class IIb when those decisions may cause a serious deterioration of health or a surgical intervention, and class III when they may cause death or an irreversible deterioration of health. Software monitoring vital physiological parameters, where variations could result in immediate danger, is class IIb. MDCG 2019-11 rev.1 (June 2025) is the current qualification and classification guidance.

The clinical evaluation consultation procedure (Article 54)

For class III implantable devices and for class IIb active devices intended to administer and/or remove a medicinal product (Rule 12), the notified body follows Annex IX Section 5.1:

1. The notified body prepares a clinical evaluation assessment report (CEAR) and sends it, with the clinical evaluation documentation of the manufacturer, to the Commission, which forwards it to the relevant expert panel (Article 106).
2. Within 21 days of receipt, the expert panel notifies through EUDAMED whether it will give a scientific opinion, using three criteria: novelty with a possible major clinical or health impact, a significantly adverse change in the benefit-risk profile of the category, or a significantly increased rate of serious incidents.
3. If it gives an opinion, it does so within 60 days of receipt.
4. The procedure is not required for a certificate renewal, for a modification of a device already marketed by the same manufacturer for the same purpose with no adverse effect on the benefit-risk ratio, or where a common specification covers the clinical evaluation and the notified body confirms compliance (Article 54(2)).

Article 61(2) also lets the manufacturer of any class III device, or of a Rule 12 class IIb device, consult an expert panel before its clinical evaluation or investigation. The views are not binding on any later conformity assessment. After certification, Article 55(1) requires the notified body to notify the competent authorities of certificates issued after the Article 54 procedure, with the summary of safety and clinical performance and, where applicable, the expert panel opinion.

The notified body: selection, audits, certificate

Selection through NANDO

The Commission database lists the bodies designated under the MDR with their scope expressed in the codes of Implementing Regulation (EU) 2017/2185, in four families: MDA (active devices), MDN (non-active devices), MDS (devices with specific characteristics) and MDT (technologies and processes). MDCG 2019-14 explains the codes. On October 7, 2026, NANDO returned 45 bodies notified under the MDR, established in 18 countries; 10 of them list MDA 0101 (active implantable devices for stimulation, inhibition or monitoring) and 8 list MDS 1002 (devices manufactured using tissues or cells of human origin), as detailed in the notified body selection guide.

Article 53(1) lets the manufacturer choose any body designated for the device type, but not apply to two bodies in parallel for the same procedure. Article 53(3) requires the manufacturer to declare any application withdrawn before a decision, and any refusal by another body.

What Annex IX imposes on surveillance

Requirement	Annex IX section	Text
Surveillance audits and assessments	3.3	At least once every 12 months, including on-site audits at the manufacturer and, if appropriate, at suppliers or subcontractors
Unannounced audits	3.4	At least once every five years, randomly, with tests on a sample of produced devices or samples taken from the market
Technical documentation sampling, class IIa and IIb	3.5	Further representative samples assessed during surveillance
Class III parts and materials	3.5	Test of approved parts and materials essential for device integrity, with quantity reconciliation where appropriate
Auditor rotation	3.6	As a general rule, a lead auditor neither leads nor attends audits of the same manufacturer for more than three consecutive years
Changes to an approved device	4.10	Changes that could affect safety and performance or the conditions of use need approval by the notified body that issued the EU technical documentation assessment certificate

Certificates are valid for the period they indicate, five years at most, and can be extended for further periods of up to five years after a re-assessment (Article 56(2)). Article 56(3) lets the notified body restrict the intended purpose to certain patient groups or require specific PMCF studies.

See the certification timeline for project framing that integrates these audit sequences.

The technical file: Annexes II and III

Annex II fixes six sections:

1. Device description and specification, including variants and accessories.
2. Information to be supplied by the manufacturer: label, instructions for use.
3. Design and manufacturing information, including the sites where design and manufacturing take place.
4. General safety and performance requirements: the applicable requirements of Annex I, the method used to demonstrate conformity, the harmonised standards or common specifications applied, and the controlled documents giving the evidence.
5. Benefit-risk analysis and risk management (Annex I Sections 1 and 3).
6. Product verification and validation: pre-clinical and clinical data, including the clinical evaluation report, the PMCF plan and evaluation report or the justification why PMCF is not applicable, plus additional information for specific cases (medicinal substance, tissues of human or animal origin, absorbed substances, CMR or endocrine-disrupting substances, sterile and measuring devices, combinations).

Annex III, the post-market surveillance documentation, has two sections only: the PMS plan (Section 1.1), which must contain a PMCF plan or a justification why PMCF is not applicable, and the PSUR or the PMS report (Section 2). Vigilance reports, trend reports and field safety corrective actions are governed by Articles 87 to 89, not by Annex III.

See also the CE technical file page for the cross-cutting framing of the technical file under CE marking.

Harmonised standards cited under the MDR (consolidated list of June 17, 2026)

Article 8(1) gives presumption of conformity only for the references listed in the annex to Implementing Decision (EU) 2021/1182. Several standards that class IIb and III files rely on are absent from it.

Standard	Status under the MDR	Entry and act
EN ISO 13485:2016 with AC:2018 and A11:2021	Cited	Entry 10 (added by Decision (EU) 2022/6, corrigendum by 2022/757)
EN ISO 14971:2019 with A11:2021	Cited	Entry 16 (Decision (EU) 2022/757)
EN ISO 10993-1:2025	Cited	Entry 54 (Decision (EU) 2026/1231)
EN 60601-1:2006 with A13:2024	Cited	Entry 65 (Decision (EU) 2026/1231)
EN 60601-1-2 (electromagnetic compatibility)	Not cited	No collateral standard of the 60601 series is listed
IEC 62304 (software life cycle), IEC 62366-1 (usability)	Not cited	Usable as state of the art, without presumption of conformity

The IEC 60601-1 guide, the risk management guide and the QMS comparison go into each standard.

UDI: carriers, dates, direct marking

Article 27 and Annex VI set the UDI system. The UDI-DI identifies the device model; the UDI-PI carries production data (lot or serial number, manufacturing or expiry date, software identification). The Basic UDI-DI is the key used in EUDAMED, in certificates and in the EU declaration of conformity. Implementing Decision (EU) 2019/939 designates the four issuing entities: GS1, HIBCC, ICCBBA and IFA GmbH.

The UDI carrier combines an automatic identification and data capture form (AIDC) and a human readable interpretation (HRI). Annex VI Part C Section 4.10 requires reusable devices to bear the carrier on the device itself, permanent and readable after each process that makes the device ready for the next use, unless direct marking would interfere with safety or performance, or is not technologically feasible.

Class	UDI carrier on label and packaging (Article 123(3)(f))	Direct marking of reusable devices (Article 123(3)(g))
Class III and implantable devices	May 26, 2021	May 26, 2023
Class IIa and IIb	May 26, 2023	May 26, 2025
Class I	May 26, 2025	May 26, 2027

Delegated Regulation (EU) 2023/2197 introduced the Master UDI-DI for standard and made-to-order contact lenses, applicable from November 9, 2025. MDCG 2025-8 rev.1 (March 2026) gives guidance on the Master UDI-DI for spectacle frames, spectacle lenses and ready-to-wear reading spectacles.

EUDAMED: module status on October 7, 2026

Regulation (EU) 2024/1860 replaced the all-or-nothing start of EUDAMED with a module-by-module one: each obligation linked to an electronic system applies six months after the Commission publishes a notice that the system is functional (Article 123(3)(d)). Decision (EU) 2025/2371 was that notice for four systems, published on November 27, 2025.

Module	Legal basis	Status
Actor registration	Article 30	Mandatory since May 28, 2026
UDI and device registration	Articles 28 and 29	Mandatory since May 28, 2026; legacy and new devices registered within 12 months of the notice
Notified bodies and certificates	Article 57	Mandatory since May 28, 2026; latest certificates entered within 18 months of the notice
Market surveillance	Article 100	Mandatory since May 28, 2026, for competent authorities and the Commission
Vigilance and post-market surveillance	Article 92	Not covered by the notice; the Commission lists it as in development, with no voluntary period before it becomes mandatory
Clinical investigations and performance studies	Article 73	Not covered by the notice; listed as under analysis

Until the vigilance and clinical investigation modules are declared functional, the corresponding provisions of the directives continue to apply for vigilance reporting and clinical investigation information (Article 123(3)(d), last subparagraph): serious incidents go to the national competent authorities through the existing channels, and PSURs of class III and implantable devices reach the notified body outside EUDAMED.

Clinical evaluation

Article 61 and Annex XIV

Article 61(1) requires the manufacturer to specify and justify the level of clinical evidence and to plan, conduct and document a clinical evaluation under Annex XIV Part A. The evaluation rests on the critical evaluation of the literature (only when equivalence is demonstrated under Annex XIV Section 3), of the results of clinical investigations, and of the available alternative treatments (Article 61(3)).

When clinical investigations are mandatory

Article 61(4) requires clinical investigations for implantable devices and class III devices, except where:

• the device modifies a device already marketed by the same manufacturer, equivalence is demonstrated under Annex XIV Section 3 and endorsed by the notified body, and the clinical evaluation of the marketed device is sufficient; the notified body then checks that the PMCF plan includes post-market studies;
• the equivalent device belongs to another manufacturer and the two have a contract giving full access to the technical documentation on an ongoing basis, with the original clinical evaluation compliant with the MDR (Article 61(5));
• the device was lawfully placed on the market under the directives and its clinical evaluation is based on sufficient clinical data and complies with any relevant common specification (Article 61(6)(a), read with MDCG 2020-6);
• the device is on the Article 61(6)(b) list, now much longer after Delegated Regulation (EU) 2026/1451.

Equivalence is assessed on technical, biological and clinical characteristics together (Annex XIV Section 3, MDCG 2020-5). Clinical investigations follow Articles 62 to 82 and Annex XV.

What the notified body checks

Annex IX Sections 4.4 to 4.8 require device reviewers with sufficient clinical expertise, external clinical experts if necessary, a documented conclusion on any claimed equivalence, and a clinical evaluation assessment report (MDCG 2020-13 is the template). For class III and implantable devices, the manufacturer drafts a summary of safety and clinical performance that the notified body validates and uploads to EUDAMED (Article 32, MDCG 2019-9 rev.1), and Article 61(11) requires the PMCF evaluation report and that summary to be updated at least annually.

Post-market surveillance: PMS, PSUR, PMCF, vigilance

PSUR cadence by class

Class	Report	Cadence (Article 85 or 86)	Notified body role
Class I	PMS report	Updated when necessary	Made available to the competent authority on request
Class IIa	PSUR	When necessary, at least every two years	Made available to the notified body and, on request, to the competent authority
Class IIb non-implantable	PSUR	At least annually	Made available to the notified body and, on request, to the competent authority
Class IIb implantable	PSUR	At least annually	Submitted to the notified body, which adds its evaluation (Article 86(2))
Class III	PSUR	At least annually	Submitted to the notified body, which adds its evaluation (Article 86(2))

The PSUR sets out the conclusions of the benefit-risk determination, the main findings of PMCF, the sales volume and an estimate of the size and characteristics of the population using the device (Article 86(1)). MDCG 2022-21 gives the PSUR guidance.

Vigilance deadlines (Article 87)

• serious incident: immediately after establishing a causal relationship, or that one is reasonably possible, and not later than 15 days after awareness,
• death or unanticipated serious deterioration of health: not later than 10 days,
• serious public health threat: not later than 2 days.

An incomplete initial report may be followed by a complete one (Article 87(6)). Trend reports (Article 88) cover statistically significant increases in non-serious incidents or expected side effects. Field safety corrective actions and field safety notices follow Article 89.

PMCF (Annex XIV Part B)

PMCF is not restricted to class IIb and III: every PMS plan contains a PMCF plan or a justification why PMCF is not applicable (Annex III Section 1.1). The PMCF plan and the PMCF evaluation report feed the clinical evaluation and the PSUR. MDCG 2020-7 and MDCG 2020-8 are the plan and report templates.

The PRRC, the authorised representative and supply interruptions

Article 15 requires a person responsible for regulatory compliance (PRRC) with either a relevant university degree and one year of experience, or four years of experience, in regulatory affairs or quality management systems relating to medical devices. Micro and small enterprises may rely on a PRRC permanently and continuously at their disposal instead of an internal one (Article 15(2)). The PRRC ensures at least the conformity check before release, the technical documentation and declaration of conformity, the post-market surveillance obligations, the vigilance reporting, and the statement for investigational devices (Article 15(3)).

A manufacturer established outside the EU designates an authorised representative (Article 11). Where that manufacturer has not complied with Article 10, the authorised representative is legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer (Article 11(5)).

Since January 10, 2025, Article 10a requires the manufacturer to inform the competent authority and its direct customers at least 6 months in advance, except in exceptional circumstances, of an anticipated interruption or discontinuation of supply that could reasonably result in serious harm to patients or public health. Article 120(13) extends that obligation to legacy devices.

Expert panels, expert laboratories and EU reference laboratories

EU reference laboratories (EURL) belong to the IVDR, not the MDR: Article 100 of Regulation (EU) 2017/746 provides for them, Implementing Regulation (EU) 2022/944 sets their tasks and criteria, and Implementing Regulation (EU) 2023/2713 designated the first ones for certain class D in vitro diagnostics (see the IVDR guide).

Under the MDR, the scientific support for high-risk devices takes two forms: the expert panels of Article 106, involved in the Article 54 procedure and in the optional Article 61(2) consultation, and the expert laboratories the Commission may designate under Article 106(7).

What the December 2025 proposal would change

On December 16, 2025 the Commission adopted proposal COM(2025) 1023 (procedure 2025/0404(COD)) to amend the MDR and IVDR. Among its provisions for higher-risk devices: the PSUR of class IIb and III devices would be updated in the first year after the certificate and every two years thereafter, or on a significant change in the benefit-risk determination; certificates would no longer be limited in time, except in duly justified cases, with periodic reviews proportionate to the risk class; and surveillance audits could move to every two years where justified by the absence of safety issues. None of this applies until the regulation is adopted and published in the Official Journal; until then, Articles 56 and 86 apply as quoted on this page.

Claims the texts contradict

Claim	What the text says
"In March 2026 the Commission extended the Article 52(4) list; check its entry into force." (made by the earlier version of this page)	Two acts of March 20, 2026: 2026/1359 amends Article 52(4) and 2026/1451 amends Article 61(6)(b). Both were published on June 29, 2026 and entered into force on July 19, 2026. The lists differ.
"Under Annex X the manufacturer remains free of a full QMS." (made by the earlier version of this page)	Article 10(9) requires every manufacturer to establish a quality management system. Annex X changes what the notified body assesses, not that obligation.
"PMCF is mandatory for class IIb and III unless justified." (made by the earlier version of this page)	Annex III Section 1.1 requires a PMCF plan, or a justification why PMCF is not applicable, in the PMS plan of every device. Article 61(11) adds the annual update of the PMCF evaluation report for class III and implantable devices.
"Annex III includes vigilance records, trend reports and field safety corrective actions." (made by the earlier version of this page)	Annex III has two sections: the PMS plan and the PSUR or PMS report. Vigilance, trend reporting and field safety corrective actions are in Articles 87 to 89.
"Market surveillance is one of the modules manufacturers must use."	Decision (EU) 2025/2371 made it functional, and the Commission states it is mandatory for competent authorities and the Commission. Manufacturers deal with Actors, UDI and devices, and certificates through their notified body.
"PSURs of class III devices are filed in EUDAMED since May 2026."	Article 86(2) uses the Article 92 system, part of the vigilance module, which Decision (EU) 2025/2371 did not cover. Its obligations start six months after its own notice.
"MDD certificates for class III remain usable until May 26, 2027."	Article 120(3a) sets December 31, 2027 for class III and class IIb implantable devices outside the well-established list, and December 31, 2028 for the other classes. May 26, 2027 is the direct-marking date for reusable class I devices, not a transition deadline.
"EN 60601-1-2, IEC 62304 and IEC 62366-1 give presumption of conformity under the MDR."	The consolidated list of June 17, 2026 cites EN 60601-1:2006 with A13:2024 but no 60601 collateral standard, no IEC 62304 and no IEC 62366-1.
"The assessment team includes a statistician." (made by the earlier version of this page)	Annex IX Sections 4.3 and 4.4 require staff with proven knowledge of the technology and its clinical application, and device reviewers with sufficient clinical expertise. No statistician is named.
"Any change to a certified device is a significant change."	The significant change test belongs to Article 120(3c)(b) for legacy devices, interpreted by MDCG 2020-3 rev.1. For MDR certificates, Annex IX Section 4.10 requires approval of changes that could affect safety and performance or the conditions of use.

Checks worth running on a class IIb or III file

• Clinical evaluation report. Literature used without demonstrated equivalence under Annex XIV Section 3; an equivalence claim with another manufacturer without the Article 61(5) contract; use of an Article 61(6)(b) exemption without the justification of Article 61(7).
• Route and list. Device type checked against both 2026 lists, not one: being exempted from the per-device assessment does not exempt from clinical investigations, and the reverse.
• UDI consistency. Data in EUDAMED, physical markings, Basic UDI-DI on the certificate and on the EU declaration of conformity; direct marking of reusable devices or a documented Section 4.10 exception.
• PSUR and PMCF. Annual PSUR in place for class IIb and III; annual PMCF evaluation report and summary of safety and clinical performance update for class III and implantable devices.
• Standards. Each standard in the GSPR checklist marked as harmonised (with its entry) or as state of the art.
• Legacy devices. Article 120(3c) conditions documented, including the written agreement date, and changes screened against MDCG 2020-3 rev.1.
• Supply. An Article 10a procedure ready for discontinuations, with the 6-month notice.

Articulation with related pages

• For the baseline MDR overview, go back to the MDR guide, which is the prerequisite for this page.
• For the general CE framework, see the CE pillar, the conformity assessment procedure, and the technical file.
• For the module/route decision, see the self-declaration vs notified body comparison.
• For notified body counts and codes, see the notified body selection guide.
• For project framing, see the certification timeline.
• For definitions, see the glossary; the NB, harmonised standard and IEC entries are the ones used here.

See also

• IVDR (EU) 2017/746: in vitro diagnostic medical devices
• FDA 510(k), De Novo and PMA: US medical devices
• QMS: ISO 9001, AS 9100, ISO 13485, TL 9000 compared
• IATF 16949: automotive quality management
• IEC 60601-1: medical electrical equipment safety
• Risk management: ISO 14971, IEC 31010, FMEA, FTA

Working on upstream regulatory positioning for a class IIb or III medical device for a real product? AESTECHNO can audit your design and certification plan. Get in touch

Sources & references

1. Regulation (EU) 2017/745 on medical devices, consolidated text of July 19, 2026, EUR-Lex eur-lex.europa.eu/eli/reg/2017/745/2026-07-19/eng
2. Regulation (EU) 2017/745 on medical devices, original text, EUR-Lex eur-lex.europa.eu/eli/reg/2017/745/oj
3. Regulation (EU) 2023/607, extension of the Article 120 transitional provisions, EUR-Lex eur-lex.europa.eu/eli/reg/2023/607/oj
4. Regulation (EU) 2024/1860, gradual roll-out of EUDAMED and Article 10a supply interruption notice, EUR-Lex eur-lex.europa.eu/eli/reg/2024/1860/oj
5. Commission Decision (EU) 2025/2371, notice on the functionality of four EUDAMED electronic systems, EUR-Lex eur-lex.europa.eu/eli/dec/2025/2371/oj
6. Commission Delegated Regulation (EU) 2026/1359, class IIb implantable devices exempted from per-device assessment (Article 52(4)), EUR-Lex eur-lex.europa.eu/eli/reg_del/2026/1359/oj
7. Commission Delegated Regulation (EU) 2026/1451, implantable and class III devices exempted from clinical investigations (Article 61(6)(b)), EUR-Lex eur-lex.europa.eu/eli/reg_del/2026/1451/oj
8. Commission Delegated Regulation (EU) 2023/2197, Master UDI-DI for contact lenses, EUR-Lex eur-lex.europa.eu/eli/reg_del/2023/2197/oj
9. Implementing Decision (EU) 2021/1182, harmonised standards under the MDR, consolidated text of June 17, 2026, EUR-Lex eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02021D1182-20260617
10. COM(2025) 1023, proposal to simplify the MDR and IVDR (December 16, 2025), EUR-Lex eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025PC1023
11. MDCG guidance documents (2019-11 rev.1, 2019-14, 2020-3 rev.1, 2020-5, 2020-6, 2022-21), European Commission health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
12. MDCG 2020-13, Clinical Evaluation Assessment Report template, European Commission health.ec.europa.eu/latest-updates/guidance-clinical-evaluation-assessment-report-template-2020-07-17_en
13. EUDAMED overview and module status, European Commission health.ec.europa.eu/medical-devices-eudamed/overview_en
14. EUDAMED, the European database on medical devices, European Commission ec.europa.eu/tools/eudamed/
15. NANDO, notified bodies designated under the MDR, European Commission webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies
16. IMDRF, UDI guidance and reference documents, IMDRF www.imdrf.org/