20 Years of Experience-MDD -IVD - MDR Experts
Preparing technical dossiers for CE marking approval and providing full guidance and support
3 European medical device directives- New..... MDR Experts 2017/745 IVDR 2017/746 - We will guide you!
In-House Seminars MDR - Gap Analysis- Submissions all classes.
CE Medical Devices Directive
EC Directive 93/42/EEC
- EC Directive 93/42/EEC
- AIMD - Active Implantable Medical Device Directive 90/385/EEC
- IVD - In-Vitro-Diagnostic-Device Directive 98/79/EC
- There are three European CE marking directives that specifically apply to medical device manufacturers:
- The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive.
- The Active Implantable Medical Devices Directive (AIMDD) applies to all active devices and related accessories intended to be permanently implanted in humans.
- The In Vitro Diagnostics Directive (IVDD) applies to all devices and kits used away from the patient to make a diagnosis of patient medical conditions.
There are 3 main directives in the European medical device field:
- General medical equipment
- Equipment for labs
- Active implants
In order to market medical devices in Europe , manufacturers of Class I sterile, and Class I with measuring function, IIa ,IIB, III need CE and ISO 13485, these certificates serve as an entrance ticket into the European marketing world.
The main stages on the route to receive a CE mark are:
- Defining the device and its intended use.
- After defining it - classification in one of the risk classes - Class I IIa, IIb or III.
Preparation of a technical dossier to submit to an authorized notified body in Europe, according to the company’s quality control procedures and ultimately an audit conducted by the notified body.
L.S.Marketing & Registration - Experts in the Medical Devices Field
A team with vast experience - 20 year’s experience in the medical device industry, expertise in registration of a wide range of medical devices. EU Rep. Services & UK Rep. Services after the Brexit.
We are very familiar with many companies both in Israel and worldwide.
Preparation of CE technical dossiers - the service includes:MDD - MDR -Submissions all classes- Gap Analysis
- Preparation of a technical dossier in cooperation with the manufacturer for the notified body.
- Reducing costs of accreditation of notified bodies.
- Preparation for external audit by the notified body.
- If the products are Class I not sterile - if necessary - assistance with finding the right European Authorized Representative - acts as a representative body in Europe to local health authorities.We are proud to represent a well known EU Rep. in Germany .