Contact MEDDEV
MEDDEV Compliance is an EU Authorized Representative established in Warsaw, Poland, working with medical-device and IVD manufacturers outside the European Union. We normally reply the same working day.
Two ways to start
Mandate or market-entry enquiry
If you are preparing EU market entry, transferring an existing EC REP mandate or unsure which route applies, start with the short qualification form. It tells us the device, the class and where the file stands, so the first reply is useful rather than generic.
Check eligibilityA conversation first
If you would rather talk through the situation before sending anything in writing, book a 30-minute online meeting at a time that fits your timezone.
Book an online meetingWho you will be talking to
Mandate governance
Mikołaj Junosza-Szaniawski
Managing Director · EC REP operations and governance
Conformity assessment
Marta Junosza-Szaniawska
Conformity assessment and EC REP mandate review
Registration
Barbara Jęcka-Izdebska
Registration, notifications and EUDAMED coordination
Sending documents
Please do not attach technical documentation, clinical data or anything confidential to a first email or to the qualification form. Once the scope and the parties are confirmed, we provide a controlled transfer route with single-use access, private EU storage and automatic deletion after the agreed period.
MEDDEV COMPLIANCE sp. z o.o.
ul. Mydlarska 47, 04-690 Warsaw, Poland
KRS 0000900989 · VAT PL9522216560
How we handle personal data submitted through this website is described in the privacy policy.