Medical Device CE Mark

CE MARK Medical Device Certification

CE Mark certification for Medical device companies is one of most sought after certifications as safety and quality is a major issue for medical devices.

Because of its widespread acceptance, it’s demanded by buyers and channel partners as a major requirement to buy and sell medical device products in India and across continents.

Benefits of Getting CE MARK Certification

Getting CE MARK certification is an achievement for your organisation and increases products acceptance in India and across the world.

• CE MARK Certificate gives you right to use the CE MARK logo on products, packaging, visiting cards, website and all print material as a mark of quality and safety of the products you manufacture or deal in.
• Reputation built up in buyers.
• Command better prices of your products in India and across the world.
• Helps in making dealers and distributors and customers for your products in India and abroad.
• Help in bagging Government tenders, corporate orders and export orders.
• Acceptance of your products as a safe and quality product in India and abroad.
• Orders in trade fairs in India and across the world.
• Help in acquiring new Indian and International clients.
• Edge over competitors.
• CE MARK Certificate creates a competitive advantage for your products and company.
• CE MARK Certificate tells your buyers and channel partners that your product is having international certification.
• The CE MARK LOGO can be affixed on the product on the information plate (along with name of the company/ model number etc..

CE MARK Certification is applicable to below listed directives and product categories

2006/ 42/ EC Machinery Directive (MD) (CE MARK Certification)
2004/ 108/ EC Electromagnetic compatibility (EMC) (CE MARK Certification)
2006/ 95/ EC Low Voltage Directive (LVD) (CE MARK Certification)
89/ 106/ EEC Construction products Directive (CPD) (CE MARK Certification)
2009/ 142/ EC Gas appliances Directive (GAD) (CE MARK Certification)
2009/ 128/ EC Inspection of pesticide application equipment (CE MARK Certification)
97/ 23/ EC Pressure equipment Directive (PED) (CE MARK Certification)
2009/ 48/ EC Toys safety Directive (CE MARK Certification)
2004/ 22/ EC Measuring instruments Directive (MID) (CE MARK Certification)
93/ 42/ EEC Medical devices Directive (MDD) (CE MARK Certification)
90/ 385/ EEC Medical devices: active implantable (CE MARK Certification)
98/ 79/ EC Medical devices: in vitro diagnostic (IVD) (CE MARK Certification)
89/ 686/ EEC Personal protective equipment (PPE) (CE MARK Certification)
94/ 62/ EC Packaging and packaging waste (CE MARK Certification)
2000/ 9/ EC Cableway installations (CE MARK Certification)
(EC) 1907/ 2006 Chemical substances (REACH) (CE MARK Certification)
(EC) 1223/ 2009 Cosmetics (CE MARK Certification)
(EU) 305/ 2011 Construction products (CPR) (CE MARK Certification)
92/ 42/ EEC Eco design, hot-water boilers (CE MARK Certification)
2009/ 23/ EC Non automatic weighing instruments (CE MARK Certification)
2010/ 30/ EU Eco design and energy labelling (CE MARK Certification)
2009/ 125/ EC Eco design and energy labelling (CE MARK Certification)
(EC) 1221/ 2009 Eco-management and audit scheme (EMAS)
94/ 9/ EC Equipment for explosive atmospheres (ATEX) (CE MARK Certification)
93/ 15/ EEC Explosives for civil uses (CE MARK Certification)
95/ 16/ EC Lifts (CE MARK Certification)
(EC) 765/ 2008 new legislative framework (NLF) (CE MARK Certification)
2007/ 23/ EC Pyrotechnic articles (CE MARK Certification)
1999/ 5/ EC Radio and telecommunications terminal equipment (RTTE) (CE MARK Certification)
2008/ 57/ EC Rail system: interoperability (CE MARK Certification)
94/ 25/ EC Recreational craft (CE MARK Certification)
2009/ 105/EC Simple Pressure Vessels (CE MARK Certification)
2011/ 65/ EU Restriction of the use of certain hazardous substances (RoHS)