Governed by the European Union Medical Device and IVD Regulations (EU 2017/745, 2017/746)
| Regulatory Authority | Ministry of Health |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, IIa, IIb and III |
| Medical Device Regulations | Medical Devices Regulation | Click Here |
| IVD Classification | A,B,C,D |
| In Vitro Diagnostics Regulations | Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices | Click Here |
| Device Classification Guidelines | MDCG 2021-24 Guidance on classification of medical devices | Click Here |
| Registration Process | Medical Devices Registration | Click Here |
| Registration Timeline | For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product |
| Conformity Assessment Route |
Chapter 5, section 2, Article 52 Annexes IX to XI |
| Technical Documentation Format |
EU MDR 2017/745 Annex II, III |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in French or German or Luxembourgish LanguageLabels for AIMD should be in French or German |
| Labeling Requirements |
For active implantable medical devices , the information to be provided to users and patients must be written in one of the following languages: French or German .
For medical devices and in vitro diagnostic medical devices , the information to be provided to users and patients must be written in one of the following languages: French, German or Luxembourgish .
For devices intended exclusively for professional use , the information may also be written in English.
| Click Here
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| Clinical Trials Information |
In Luxembourg , any request for clinical investigation or substantial modification of a clinical investigation is also subject to prior authorization from the Minister, based on the scientific and ethical opinions of the Health Directorate and the National Research Ethics Committee (Art. 27 of the Law of March 8, 2018 relating to hospital establishments and hospital planning ). | Click Here |
| Declaration of Conformity |
Annex II, article 19 of EUMDR 2017/745 |
| Certificate of Free Sale |
The Certificate of Free Sale (CLV) is a document that certifies that a medical device from a Luxembourg manufacturer or representative complies with applicable legislation and may be marketed in the European Union (EU). The CLV is intended for a health authority in an importing country outside the EU. It is requested by a manufacturer or representative for the purpose of exporting a medical device (MD) or an in vitro diagnostic medical device (IVD) outside the EU. | Click Here |
| Field Safety Corrective Action |
Regarding FSNs (Field Safety Notices), reflecting the linguistic situation of the medical sector in Luxembourg, we suggest at least the French and German versions in addition to the English version. FSCA notifications must also be accompanied by:
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| Additional Information | Any medical device bearing the CE marking, indicating that it has been subject to a conformity assessment, can be made available on the market and put into service. |
| Contact Email | meddevices@ms.etat.lu |
| Contact Website | Click Here |