Luxembourg Medical Device Registration

Medical Device Registration in Luxembourg: EU MDR Compliance and Regulatory Guidelines

Regulatory Authority

Ministère de la Santé

Link for Regulatory Authority

https://sante.public.lu/dam-assets/fr/politique-sante/ministere-sante/direction-sante/div-pharmacie-medicaments/medical-devices-EN.pdf

Local Regulation

EU MDR 2017/754

Classification of Medical Device

Class I, IIa, IIb and III

Listing or Registration Requirements

• To register a device, you must first determine its risk class (I, IIa, IIb, or III) and appoint representatives if necessary. If your company is not established in the EU, you can appoint an Authorized Representative or a Notified Body for high-risk devices.
• Complete a Technical File with all relevant information about your device, including design, manufacturing processes, safety and performance data, and risk assessments. Obtain a Unique Device Identification (UDI) and register it in the European Eudamed database for traceability and post-market surveillance.
• Conformity assessment is required by your Notified Body or self-declare conformity for Class I devices. The Notified Body reviews your Technical File and may conduct audits or tests.
• Once your device meets all requirements, prepare, and sign a Declaration of Conformity stating its compliance with the relevant regulation. Attach the CE marking to indicate compliance and allow it to be marketed within the EU, including Luxembourg.
• Implement a Post-Market Surveillance Plan to monitor the device’s safety and performance after it is placed on the market. In Luxembourg, you must register with the Luxembourg Directorate of Health and ensure user instructions and labels are translated into French, German, or Luxembourgish.

Documents Required

• Certificate of free sale (FSC)
• DoC
• Technical File
• User Instructions and Labeling 

Registration Timeline

The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device 

License Validity

5 Years

Special Labelling Requirements

• For active implantable medical devices, the instructions 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

Additional Comments

Two new EU regulations, MDR (EU) 2017/745 and IVDR (EU) 2017/746, replaced the previous directives for medical devices and in vitro diagnostic devices in May 2017. These stricter regulations implemented new requirements for safety, efficacy, and quality. 

Existing devices had transitional periods before the regulations fully applied: three years for MDR (meaning it applied to all new devices after May 26, 2020) and five years for IVDR (applying to all new devices after May 26, 2022). These regulations apply throughout the EU, including Luxembourg. For accurate and up-to-date information about medical device registration in Luxembourg, consult official resources like the Ministry of Health of Luxembourg website. 

Who should make this communication?

• Manufacturer
• Authorized Representative

When to make this communication?

Before placing a medical device into the market.

Market overview

The projected revenue for the Medical Devices market in Luxembourg is estimated to reach US$183.20 million in 2024, with Cardiology Devices being the largest segment, expected to have a market volume of US$25.15 million in the same year. Anticipated to display an annual growth rate (CAGR 2024-2028) of 3.90%, the revenue is forecasted to reach a market volume of US$213.50 million by 2028.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk