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Austria medical device registration resources

Research BASG registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Austria medical device resource.

5 free resources23/25 topics with recordsAug 2026 fees reviewed
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Medical device regulation news

Follow recent Federal Office for Safety in Health Care (BASG) policy, guidance, safety, and compliance updates.

AI medical device classifier

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Government registration fees

Review current BASG application, review, and renewal fees.

Registration timeline

Compare the statutory notified-body conformity assessment clock under Regulation (EU) 2026/977 with realistic CE marking times by device class.

Structured regulatory requirements

Explore all 37 source-linked facts →

23 of 25 research dimensions currently covered · 29 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
Competent authority
The Federal Office for Safety in Health Care (BASG, Bundesamt für Sicherheit im Gesundheitswesen) is the competent national authority for medical devices and IVDs under Regulations (EU) 201…
1 source-linked fact
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
National implementation law
The national framework law is the Medizinproduktegesetz 2021 (MPG 2021), BGBl. I Nr. 122/2021, in force since 1 July 2021 (for IVDs since 26 May 2022), as amended by BGBl. I Nr. 192/2021, B…
1 source-linked fact
Checked 2026-08-25
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D03

Device definition & scope

Verified
National delimitation and classification advisory board
An Abgrenzungs und Klassifizierungsbeirat (delimitation and classification advisory board) is established at the Federal Ministry; it issues expert opinions (Gutachten) on whether a product…
National in-house device restrictions
For in house devices (health institution manufacturing under Art. 5(5) MDR), the Health Minister may by ordinance designate devices that may not be manufactured and used in health instituti…
2 source-linked facts
Checked 2026-08-25
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D04

Classification rules

Verified
EU MDR 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 2026-08-26
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D05

Registration pathways

Verified
Austrian Medizinprodukteregister operator
The Austrian register for medical devices (medizinprodukteregister.at) is a free, web based database operated by Gesundheit Österreich GmbH (GÖG, ÖBIG division) on behalf of the Ministry; i…
Market-access route or official registration surface
submissionSurface: EUDAMED (actor registration verified/validated by BASG; actor, device and certificate modules mandatory since 28 May 2026) plus the Austrian Medizinprodukteregister (GÖG)…
3 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
NMPA certificate does not replace EU conformity assessment
statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and proce…
EU CE under MDR/IVDR — single market validity
target: geo:aut · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…
2 source-linked facts
Checked 2026-09-15
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D07

Economic-operator roles

Verified
Medizinprodukteberater (national device advisor role)
Operators who commercially place medical devices on the market may only entrust the informing and training of professional circles (Fachkreise) to Medizinprodukteberater possessing the requ…
1 source-linked fact
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Importer/distributor risk and falsification notification
Importers and distributors who consider or have reason to believe that a device they placed on the market in Austria poses a serious risk or is a falsified product must immediately inform B…
1 source-linked fact
Checked 2026-08-25
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D09

Dossier requirements

Verified
Conformity documentation in German on BASG request
Upon reasoned request of BASG, all information and documents required to demonstrate the conformity of the product must be submitted in German.
1 source-linked fact
Checked 2026-08-25
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D10

Official forms & portals

Verified
Clinical investigation submissions electronic-only
Applications, notifications, reports and other documents for clinical investigations of medical devices and performance studies of IVDs must be submitted to BASG mandatorily and exclusively…
Official form or portal surface
submissionSurface: EUDAMED (actor registration verified/validated by BASG; SRN issued on registration) plus BASG national surfaces: web form applicationform.basg.gv.at/mpgform for clinical…
2 source-linked facts
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Declaration of conformity in German on request
On request of users or patients, the EU declaration of conformity (Art. 19 MDR / Art. 17 IVDR) and the declaration for custom made devices must be provided in German.
Field safety notification in German
Field safety notifications for field safety corrective measures in Austria must be drawn up by the manufacturer in German and submitted to BASG together with the report form and the custome…
3 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
Operator ordinance for health facilities
The Medizinproduktebetreiberverordnung (MPBV, BGBl. II Nr. 70/2007) imposes national operator duties on health facilities for erecting, operating, using and maintaining medical devices, inc…
Recurring technical safety checks
Active non implantable medical devices operated in health facilities must undergo recurring technical safety checks at intervals set by the manufacturer or, absent manufacturer specificatio…
2 source-linked facts
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
MDR electrical safety in place of the Low Voltage Directive
Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive
EMC
FMaG 2016 radio equipment market access
Wireless / radio
7 maintained overlays
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D14

Fees

Verified
Annual medical-device levy (Medizinprodukteabgabe) - Class I
EUR 250
Annual medical-device levy - Class IIa
EUR 300
13 maintained fee lines
Checked 2026-08-25
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D15

Review clocks

Unresolved
Class I · Self-declaration (no notified body)
0 days
1 maintained pathway · 1 related fact
Checked 2026-08-29
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D16

Approval validity & renewal

Verified
Certificate validity and renewal (Art. 56(2))
EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be…
1 source-linked fact
Checked 2026-08-29
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Lifecycle & post-market

D17

Change control

Verified
Substantial-change notification for clinical investigations
Substantial changes to an ongoing clinical investigation (Art. 75 MDR / § 13 Abs. 3 MPG 2021, affecting the investigation plan, the investigator's manual/brochure or the investigational pro…
1 source-linked fact
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
National pacemaker/ICD/loop-recorder register
Austria operates a national register for pacemakers, implantable defibrillators and loop recorders; implanting or treating health institutions must transmit institution, patient, clinical a…
Official UDI or listing surface
submissionSurface: EUDAMED device registration and UDI database (mandatory since 28 May 2026; devices already on the market to be registered by 28 November 2026) plus the national GÖG impla…
2 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Legal basis for electronic-only study submissions
Applications, notifications, reports and other documents in clinical investigation and performance study procedures must be submitted to BASG mandatorily and exclusively in electronic form…
Final positive ethics vote required in BASG application
An application to BASG for a clinical investigation or performance study (initial application or amendment) must contain the final positive ethics committee vote; a provisional vote or a pr…
2 source-linked facts
Checked 2026-08-25
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D20

Special access & derogation

Verified
Exemption permit procedure (Art. 59 MDR / Art. 54 IVDR)
Applications for exemptions in the interest of health protection under Art. 59 MDR / Art. 54 IVDR must contain per § 12 MPG 2021: the exact designation of the required device including acce…
Physician self-attestation exception
No exemption permit is required where a self employed physician or dentist established in Austria certifies that a device without completed conformity assessment is needed for an individual…
2 source-linked facts
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
Post-market surveillance reporting (Arts. 83-86)
Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device…
1 source-linked fact
Checked 2026-08-29
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D22

Vigilance & incident reporting

Verified
Suspected falsification reporting
Where there is suspicion of falsification of a medical device, this must be reported to BASG immediately (unverzüglich); devices involved in incidents must not be destroyed but must be subj…
National vigilance reporting channel
Until EUDAMED is fully functional, manufacturers and authorised representatives must report serious incidents and field safety corrective measures in Austria by email to medizinprodukte@bas…
3 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
FSCA report package
A field safety corrective action in Austria is reported to BASG by email with the FSCA report form (.xml and .pdf files) together with the customer list, the field safety notification in Ge…
1 source-linked fact
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
Consumer advertising prohibition
Consumer directed advertising is prohibited for: medical devices subject to prescription by ordinance under § 67 MPG 2021; devices intended to be used on or for patients by health professio…
Purpose claims must match labelling and IFU
Statements on the intended purpose in advertising material for medical devices must not contradict the labelling and the instructions for use.
2 source-linked facts
Checked 2026-08-25
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D25

Submission communications & appeal

Verified
Four-week Beschwerde against a Bescheid
A decision of BASG or of another Austrian authority on a medical device is a Bescheid, so it is challenged by Beschwerde to the administrative court. VwGVG § 7(4) gives four weeks from Zust…
MPG ethics-application cure and clock handling
After an ethics committee application arrives, the committee must check whether it is in order and tell the sponsor immediately, and at the latest within five working days of receipt (MPG 2…
2 source-linked facts
Checked 2026-08-30
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Government fees

Full fee schedule (13 lines) →

BASG registration fees in EUR · reviewed 2026-08-25

Fee lineAmountProvenance
Annual medical-device levy (Medizinprodukteabgabe) - Class IEUR 250Verified
Annual medical-device levy - Class IIaEUR 300Verified
Annual medical-device levy - Class IIbEUR 350Verified
Annual medical-device levy - Class IIIEUR 400Verified
9 more fee lines on the full schedule · 13 of 13 rows source-verified

Registration timeline

Full registration timeline →

Austrian Federal Office for Safety in Health Care (BASG) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU MDR classification

Class / pathwayReview clockPlanning totalProvenance
Class I(Self-declaration (no notified body))0 days6-9 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(0 days)
  5. 5Registration Approval(1-2 weeks)
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