We provide consultancy on MDR-compliant CE marking for new medical devices and approval for modifications to products with existing markings. We also manage the relationship with notified bodies.
Medical devices can circulate freely in the European Union when CE marking is applied to devices. Securing CE marking requires conformity with the 2017/745 medical device regulation (MDR) and the relevant harmonised standards.
The aim of the medical device regulation is to ensure the manufacturer provides evidence of compliance with general safety and performance requirements laid out by the regulation.
We develop quality systems based on ISO 13485 for companies that manage medical devices, which also ensures conformity with the 2017/745 medical device regulation (MDR).
In addition, we provide on-site support for certification and monitoring audit from the competent authority.
We develop technical files for the certification of class I and class I sterile medical devices (electromedical and non-electromedical), including those with measuring functions and those that are reusable, as well as class IIa, IIb and III devices; based on the 2017/745 medical device regulation (MDR) and harmonised standards.
We manage the registration of manufacturers, importers, authorised representatives and medical devices on to the Eudamed database. We also secure and support the use of the UDI code (UDI-DI, UDI-PI and basic UDI).
In addition to consultancy for CE marking of medical devices, we also deliver approved training courses on European and Italian regulation in the medical industry.
Use the details in the contact section to get in touch: we can give you more information, organise an initial meeting, create a bespoke service, or put together a dedicated quote.
Services
Sistemir EU S.r.l.
Lecco, LC 23900
Via Ponte Alimasco, 13
segreteria@sistemir.com
+39 0341 1716381
VAT n. 03924150133
Administrative index no. LC-407096
Share capital € 10,000.00 fully paid
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