CE Marking of Medical Devices

CE-Marking of Medical Devices

Since 1998 CE-Mark is required on all medical devices marketed in Europe. The CE-Mark is a proof of compliance with so called “Essential Requirements“ of the Medical Device Directive.

The EU Medical Device Directive allows manufacturers several options to achieve conformity of product with MDD provisions. Based upon product risk classification manufacturers can select between several alternative routes of the Conformity Assessment Procedures. MT Promedt Consulting offers “hands-on” assistance to medical device manufacturers to fulfill legal requirements in a fast and cost-effective way. Our services guide you through the complexities of the EU Directives. This includes also the compliance with specific national registration requirements.

We support our clients in the definition of the most reasonable conformity assessment procedure, the liaison with Notified Bodies up to product safety tests i.e. biocompatibility tests, process and sterilization validation, preparation of technical product documentation and clinical trials up to the conformity declaration. Our Quality Management Consulting Services will help you in the preparation of the Certification Audit. As soon as you received your CE-mark, we are prepared to take over the responsibility as your Authorized Representative in Europe.

MT Promedt Consulting offers 'hands-on' assistance on the followings areas:

	Product classification
	Selection of reasonable Conformity Assessment Procedure
	Risk Management
	Development and implementation of QM system
	Definition and coordination of product testing programs
	Biocompatibility Assessment Program
	Sterilization Validation (EO, Steam, Gamma)
	Packaging Validation
	Preparation of Technical Product Documentation and Design Dossier
	Clinical Evaluation
	Labeling review
	CE-conformity declaration
	Assistance in Vigilance Reporting
	Functioning as Authorized European Representative

The AIMDD and MDD have been revised in 2007 (Directive 2007/47/EEC) that will affect a number of important aspects of implementation. These will become mandatory in 2010. MT Promedt Consulting can advise you how these changes are to affect your products and business. Contact us