ACTIVE MEDICAL DEVICES
IMPLANT MEDICAL DEVICES
DISPOSABLE MEDICAL DEVICES
SOFTWARE MEDICAL DEVICES
IVD MEDICAL DEVICES

CE Certification of Medical Equipments, Disposables

Compliance with European Medical Device Regulation and CE Certification is mandatory of sale of device in Europe. CE Certification means compliance to harmonized standards and process wherein the safety is stablished by the manufacturer.

The List of CE Certification requirements available on request

CE marking is mandatory for medical device manufactures in any of the below mentioned countries or those exporting to these countries so called 28 Member states.

Austria

Belgium

Bulgaria

Croatia

Cyprus

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Poland

Portugal

Romania

Slovakia

Slovenia

Spain

Sweden

United Kingdom

And five Candidate countries (1) Albania (2) Montenegro (3) Serbia (4)  The former Yugoslav Republic of Macedonia ( 5 ) Turkey

CE Mark Logo

ce logo

CE Marking a complex process.

Achieving CE Certificate is a complex and tedious process because of the new requirements of MDR and IVDR. Selection of qualified, experienced consultants is one important factor to avoid undue delay and cost cuts.