CE mark on a medical device or IVDs conforms that the device meets regulatory demand which is necessary to enter into the EU marketplace. A minor error in specialized file may delay your process of getting CE mark for a device. Boost your chances to get CE Marking Certification fluently with Operon Strategist.
Why do you need CE Marking?
Short answer is, you get to sell in further countries globally thereby adding your footmark exponentially and also it helps in building credibility within doctor’s community in India. Every country follow their own regulatory system, for eg USFDA is for dealing in the US. CE Mark is mandatory to sell medical devices within any of the 32 European Union countries. It also validates that your device comply with all regulations put forward by European Union, which is accepted by numerous other countries too.However CE mark is accepted by numerous countries and hence investment can be justified fluently.
Medical Device Directive is one of the most complex directive and one which involves strict alert by the European Authorities. way for CE marking for Medical Devices of Class 1s, IIa, IIb and III are as follows
- Apply a quality operation system ISO 134852012 as per annex II & V of MDD( not needed for class I non sterile non measuring devices).
- Appoint an European authorized representative( needed by non EU manufacturer only).
- Apply General & product specific norms as applicable to the medical device particularlyBio-compatibility( ISO 10993 series for Implants and IEC 60601 series for Electromedical products).
- Prepare a technical file comprising of detailed manufacturing process, devices description, test reports, risk analysis, Instruction for Use, labeling, applicable normsetc.
- Submit the specialized file & QMS documents to notified body for approval.
- Notified Body conducts onsite inspection through approved adjudicators.
- Restate IFUs & labels to the original language of the country to which you want to export.
CE mark Approval process will vary according to the Class of medical device, as per the MDR CE marking Approval correspond of few further things similar as product quality, technical dossier submission to NB, clinical evaluation and so on. numerous medical device manufacturers do n’t really read the regulations of EU MDR and they get stuck nearly in the process, which may delay the project to avoid that you need to know where to start and who's right CE marking consultant for you.
Operon strategist don’t leave you before, we make sure that our customer should get the CE approval with minimal efforts. We've a well- experienced staff of expert engineers and significant knowledge and familiarity with the CE marking process. We've a wide knowledge of safety standards, product safety assessments, product design and the real- world issues faced by the manufacturing industries. Our CE Mark Consultant assists new medical device manufacturers to launch a new device into the EU market.
Manufacturer should have CE marking for some product groups for dealing their products in the EEA( European Economic Area), that includes the EU countries and EFTA countries.
In case you're an importer, you need to make sure that these products that aren't made in the EEA have CE mark, as it's also obligatory for foreign products to place in the EEA market.
The following countries are part of the European Union, CE mark is needed for these countries
- Austria
- Belgium
- Bulgaria
- Cyprus
- Czech Republic
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Italy
- Latvia
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Poland
- Portugal
- Republic of Ireland
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- United Kingdom
The following countries are EFTA countries, CE mark is also needed
- Iceland
- Norway
- Liechtenstein
- Switzerland
Countries that are part of the CEFTA( Central European Free Trade Agreement), doesn't bear CE marking to vend their products.
The following countries are part of the CEFTA
- Republic of Macedonia Croatia Serbia Montenegro
- Albania
- Moldova
- Bosnia
- Herzegovina
still, some of the mentioned countries, similar as Republic of Macedonia, Croatia, Serbia, Montenegro, are members of the EU formerly and have adopted the EU legislation.
The CE Mark also has Agreements on Mutual Recognition of Conformity Assessment between the European Union and countries similar as the following
- Australia
- Canada
- Israel
- Japan
- New Zealand
- Turkey
For any medical device regulations regarding information please feel free to contact : enquiry@operonstrategist.com
Or Visit : https://operonstrategist.com/
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