CInMED · Europe

Montenegro medical device regulatory resources

Every Montenegro dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

5 free resources24/25 topics with records6 regulations trackedSep 2026 fees reviewed

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AI medical device classifier

Describe your device and get a preliminary CInMED risk class with an explanation and source links.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Montenegro requirements.

Government registration fees

Review current CInMED application, review, and renewal fees.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Browse Montenegro's official medical-device instruments — the consolidated Law on Medical Devices, the rulebook on recognition of foreign documents and CE marking, and CInMED's registration and fee decisions — with citeable Montenegrin passages.

Structured regulatory requirements

Explore all 47 source-linked facts →

24 of 25 research dimensions currently covered · 23 official sources · latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified

Competent authority and its delegated tasks: statement: The competent authority for medical devices is the Institute for Medicines and Medical Devices of Montenegro — CInMED (Institut za ljekove i medicinska sredstva Crne Gore). It ke…

1 source-linked fact

Checked 2026-09-16

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D02

Legal basis & guidance

Verified

Legal basis: Law on Medical Devices and the recognition/registration rulebook: statement: Medical devices in Montenegro are governed by the Law on Medical Devices (Sl. list Crne Gore br. 024/19 of 22 April 2019), amended by the Law amending the laws containing provisi…

1 source-linked fact

Checked 2026-09-16

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D03

Device definition & scope

Verified

Products excluded from the Law on Medical Devices: statement: The Law on Medical Devices does not apply to medicines; cosmetic products; human blood, blood products, plasma or blood cells of human origin, or products containing them at the…

1 source-linked fact

Checked 2026-09-16

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D04

Classification rules

Verified

Montenegrin classes I, Is, Im, Ir, IIa, IIb and III: Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III

1 maintained scheme

Checked 2026-09-16

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D05

Registration pathways

Verified

Registration is filed on a form prescribed by risk class: statement: The application for registration, for extension of the registration period, for amendment/supplement of registration data and for deletion from the register of medical devices is…
90-day registration deadline and who is entered in the register: statement: Within 90 days of the submission of complete documentation the Institute enters in the register: the medical device, the manufacturer, the legal person carrying out wholesale and…

3 source-linked facts

Checked 2026-09-16

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D06

Reliance & recognition

Verified

Recognition of a foreign conformity document and CE marking: statement: Recognition of a conformity document and of the CE mark issued by a conformity assessment body that has no seat in Montenegro is carried out by the Institute within the medical d…
Direct recognition is limited to EU notified-body documents and CE marking: statement: A foreign document, or the CE mark, is directly recognised in Montenegro if it was issued by a notified body of the European Union, or if it was affixed to the device in accordan…

6 source-linked facts

Checked 2026-09-16

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D07

Economic-operator roles

Verified

Local authorised representative and responsible persons: statement: The registration application must be filed by a manufacturer seated or residing in Montenegro or its authorised representative, and for a manufacturer without seat, stay or resid…

1 source-linked fact

Checked 2026-09-16

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D08

Establishment, import & distribution

Verified

Importer's verification duties before placing on the market: statement: An importer of a medical device from a non EU country may place on the market only a device for which conformity assessment has been carried out under the Law. Before placing the…
Import and export only by persons entered in the importer register: statement: Import and export of medical devices may be carried out by domestic and foreign legal and natural persons entered in the register of importers kept by the Institute. The registra…

2 source-linked facts

Checked 2026-09-16

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D09

Dossier requirements

Verified

Documents accompanying a device registration or renewal application: statement: An application to register (or to renew the registration of) a medical device is filed on the prescribed form together with: (1) the number of the registration decision of a manu…

1 source-linked fact

Checked 2026-09-16

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D10

Official forms & portals

Verified

Prescribed application forms, one per device class, annexed to the registration rulebook: statement: An application to register a medical device, to renew its registration period, to amend or supplement registration data, or to delete a device from the register of medical device…

1 source-linked fact

Checked 2026-09-16

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Submission & evidence

D11

Label, IFU & language

Verified

Instructions for use in Montenegrin with certified translation: statement: The instructions for use of a medical device must be written in the Montenegrin language and in the languages in official use in Montenegro, in line with the registration, and mu…
Outer packaging labelling and the Montenegro label: statement: The outer and inner packaging of a medical device for professional use must be labelled in Montenegrin and in the languages in official use in Montenegro; exceptionally the outer…

2 source-linked facts

Checked 2026-09-16

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D12

QMS, audit & inspection

Verified

Health-inspection powers over GMP, GLP and GDP documentation and their application: In carrying out official controls the health inspector is empowered and obliged to review the general and individual acts, records, contracts, technical documentation and other documentatio…
Non-EU manufacturers document their quality system with an ISO 13485 certificate or a free-sale certificate: A manufacturer outside the European Union applying to register a medical device must file, in addition to the standard dossier, a free sale certificate or a certificate issued by a body aut…

3 source-linked facts

Checked 2026-09-16

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D13

Standards, testing & ancillary approvals

Unresolved

Montenegrin electrical-equipment safety requirements: Electrical safety
Montenegrin electromagnetic-compatibility requirements: EMC
EKIP radio-equipment market access: Wireless / radio

8 maintained overlays

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D14

Fees

Verified

Registration of Class I medical devices — up to 25 products in the application: EUR 100
Registration of Class I medical devices — over 100 products in the application: EUR 60

11 maintained fee lines

Checked 2026-09-16

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D15

Review clocks

Verified

Class I — registration of the medical device in the CInMED register · Application for entry in the register of medical devices, filed with CInMED before the device is placed on the market by the manufacturer established in Montenegro or by its authorised representative (čl. 38(1)): 90 days
Class IIa, IIb and III — registration of the medical device in the CInMED register · Application for entry in the register of medical devices after conformity has been determined by a notified or appointed body (čl. 18), filed by the manufacturer established in Montenegro or its authorised representative (čl. 38(1)): 90 days
Authorisation to import a medical device that is not registered (čl. 66) · Request to CInMED for authorisation to import an unregistered medical device: 30 days

5 maintained pathways

Checked 2026-09-16

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D16

Approval validity & renewal

Verified

Registration decision validity, renewal and the 90-day run-off: statement: The registration decision's validity period cannot be longer than 60 days after the expiry of the conformity document. For Class I devices (other than Class Is and Class Im) and…

1 source-linked fact

Checked 2026-09-16

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Lifecycle & post-market

D17

Change control

Verified

Amendment of register data before the change is introduced: statement: The entities entered in the register must file an application with the Institute for every amendment or supplement of the register data before introducing the change. The Institu…

1 source-linked fact

Checked 2026-09-16

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D18

UDI, listing & traceability

Verified

Manufacturer keeps a record of the type and quantity of devices sold in Montenegro: A manufacturer must, among the special conditions it has to meet, establish and maintain a post market surveillance plan for the device — except for a device made to order for a particular…
Specialised retail outlets keep per-package records of devices sold in Montenegro: A specialised retail outlet may carry on retail trade in medical devices only if it meets the prescribed conditions, one of which is that it keeps a record of the type and quantity of medic…

4 source-linked facts

Checked 2026-09-16

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D19

Clinical investigation & performance

Verified

The Agency may accept a clinical-investigation control carried out by an EU member state: The Agency may carry out a control of a clinical investigation and also at the sponsor's request, and it may accept a control of the clinical investigation carried out, in accordance with g…
40-day approval clock, 10-day deficiency notice, 20 days to supplement, clock stops while supplemented: The Agency issues an approval for a clinical investigation within 40 days of receiving a complete application with documentation, including a positive opinion of the Ethics Committee. If th…

5 source-linked facts

Checked 2026-09-16

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D20

Special access & derogation

Verified

Authorisation to import unregistered devices: statement: The Institute may authorise the import of medical devices that are not registered where there is an urgent medical need, for the protection of public health, and in the following…

1 source-linked fact

Checked 2026-09-16

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D21

Manufacturer PMS

Verified

Continuous post-market monitoring by manufacturer or authorised representative: statement: The manufacturer, or the authorised representative, must continuously monitor the medical device on the market in order to identify the need to apply immediately all necessary co…

1 source-linked fact

Checked 2026-09-16

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D22

Vigilance & incident reporting

Verified

Safety corrective action must be notified without delay: statement: The manufacturer, or the authorised representative, must notify the Institute without delay of an initiated safety corrective measure and must give a safety notice to all the ent…
Who must report an incident to the Institute, and what counts as an incident: statement: Healthcare institutions or vigilance coordinators, healthcare professionals, the manufacturer or its authorised representative, wholesalers, persons involved in the delivery or p…

2 source-linked facts

Checked 2026-09-16

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D23

Recall, FSCA & market surveillance

Verified

On a health risk the Agency proposes suspension, prohibition of trade or withdrawal to the health inspection: If the Agency establishes that a medical device conforming to the essential requirements, or a device made to order for a particular patient, when correctly installed, maintained and used i…
The Agency publishes on its website the measures taken for a serious risk a device poses: The Agency publishes on its website the notification of the measures and activities undertaken in connection with a serious risk that a medical device poses to public health and to the safe…

4 source-linked facts

Checked 2026-09-16

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D24

Advertising, claims & promotion

Verified

Advertiser keeps six categories of records, publishes an annual advertising report and files it with the Ministry: An advertiser must keep records of: parallel promotions (name, seat and activity of the legal person carrying out the parallel promotion, and the expert associate's name, residence, employm…
Expert-public promotional material: 'For expert public only!', registration date, and no 'safe' claim: Advertising a medical device to the expert public is done by delivering promotional material, providing information at scientific and promotional events, in expert journals and other forms…

4 source-linked facts

Checked 2026-09-16

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D25

Submission communications & appeal

Verified

Change control: 60-day decision clock, 30-day deficiency remedy, notification-only for safety-neutral changes: Operators must file an application with the Agency for every amendment or supplement to the data in the register before introducing the change. If the application to amend or supplement the…
Registration: 90-day entry clock, 30-day deficiency remedy, clock stops while documents are supplied: The Agency enters into the register the medical device, the manufacturer, the legal person engaged in wholesale and retail trade in the medical device, and the importer, within 90 days of t…

2 source-linked facts

Checked 2026-09-16

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Government fees

Full fee schedule (11 lines) →

CInMED registration fees in EUR · reviewed 2026-09-16

Fee line	Amount	Provenance
Registration of Class I medical devices — up to 25 products in the application	EUR 100	Verified
Registration of Class I medical devices — over 100 products in the application	EUR 60	Verified
Registration of Class IIa medical devices — up to 25 products in the application	EUR 200	Verified
Registration of Class IIb medical devices — up to 25 products in the application	EUR 300	Verified

7 more fee lines on the full schedule · 11 of 11 rows source-verified

Registration timeline

Full registration timeline →

Institut za ljekove i medicinska sredstva Crne Gore (CInMED) review clocks and planning ranges · 4-class (I, IIa, IIb, III) under the Zakon o medicinskim sredstvima; CInMED's register adds Is, Im and Ir and records active implantable devices (AIMD) as a separate category, and in vitro diagnostic devices on the separate A, B, C, D axis classification

Class / pathway	Review clock	Planning total	Provenance
Class I — registration of the medical device in the CInMED register(Application for entry in the register of medical devices, filed with CInMED before the device is placed on the market by the manufacturer established in Montenegro or by its authorised representative (čl. 38(1)))	90 days	3-6 months	Verified
Class IIa, IIb and III — registration of the medical device in the CInMED register(Application for entry in the register of medical devices after conformity has been determined by a notified or appointed body (čl. 18), filed by the manufacturer established in Montenegro or its authorised representative (čl. 38(1)))	90 days	4-9 months	Verified
Authorisation to import a medical device that is not registered (čl. 66)(Request to CInMED for authorisation to import an unregistered medical device)	30 days	1-2 months	Verified
Approval to start a clinical investigation of a medical device(Request to CInMED for approval to begin a clinical investigation, including a positive opinion of the ethics committee)	40 days	2-4 months	Verified

1 more pathways on the full timeline · 5 of 5 clocks source-linked

1Pre-Submission Preparation(1-3 months)
2Application Submission(1-2 weeks)
3Administrative Review(2-4 weeks)
4Technical Evaluation(90 days)
5Registration Approval(1-2 weeks)

Key regulations

All 6 Montenegro regulations →

Official CInMED rules and guidance · 6 of 6 documents linked to official sources

CInMED, dokument Za740.01-05-IMS (18.06.2025)Način priznavanja deklaracije o usaglašenosti i EC sertifikata u postupcima koji se vode pred Institutom — prelazak sa EU direktive IVDD na regulativu IVDR (EU) 2017/746

RegistrationVerified

CInMED, dokument Za740.01-05-IMS (18.06.2025)Način priznavanja deklaracija o usaglašenosti i EC sertifikata u postupcima koji se vode pred Institutom — prelazak sa EU direktiva MDD/AIMD na regulativu MDR (EU) 2017/745

RegistrationVerified

CInMED, Uputstvo (dokument Za740.01-05-IMS), ažurirano 18.03.2026Uputstvo za podnosioce zahtjeva za registraciju medicinskog sredstva (Guide for applicants for the registration of a medical device), revised 18 March 2026

RegistrationVerified

„Službeni list Crne Gore“ br. 035/23Odluka o visini i načinu plaćanja naknada za vršenje stručnih poslova u vezi sa medicinskim sredstvima (Decision on the amount and manner of payment of fees for professional services relating to medical devices)

RegistrationVerified

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