Our services are backed by over 25 years of experience with CE Marking consultation and European Authorized Representative services. We are located within walking distance of the European Commission and maintain close relations with the EU Administration.
“Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate for this device a single authorized representative in the European Union”. -Amendment 42 Article 2, Point 7 - Article 14, paragraph 2, subparagraph 1
Our services in this area include, but are not limited to:
According to the European Medical Device Directive 93/42/EEC and the In-Vitro Diagnostic Directive 98/79/EC, CE marked and properly registered devices in all 27 EU member states and 4 EFTA countries have free access to the EU market (according to Article 14 MDD 93/42/EEC as amended by the 2007/47/EC and Article 10 IVDD 98/79/EC). Thus, once your device is properly CE marked, it is allowed to circulate and be sold throughout the European Union.
However, the CE Marking only enables penetration to the European market and does not enable the device to be placed on other global markets.
Due to the high standards of health and safety required by the CE Marking, customers in non-EU countries request a Free Sales Certificate from the manufacturer to demonstrate the device meets the various safety and health requirements specified by the CE Marking. The Certificate will enable the device to penetrate the market of the relevant country and be freely sold to the public (presuming all local requirements are also met).
As the manufacturer is not within the European territory and cannot communicate with the Authorities, this certificate can only be obtained through the manufacturer’s legal entity in Europe, the Authorized Representative.
In order to get the Free Sales Certificate for MDD and IVD devices, two conditions need to be met:
The device must bear the CE Marking
The manufacturer has appointed a European Authorized Representative for his device
If the device(s) are CE marked, but not properly notified/registered with the European Authorities by the appointed European Authorized Representative (as required by Law for MDD Class I and IVD devices), the CE Marking is NOT valid and therefore the Free Sales Certificate cannot be issued.
To receive a Free Sales Certificate, you will be required to present your Authorized Representative with the following:
Most medical device companies that currently sell CE-marked medical devices are getting nervous thinking about implementation of EU-MDR compliance and new certification. Especially related to the necessity to present sufficient clinical evidence to support the general safety and performance requirements. The Medical Devices Regulation applicable as of 26 May 2020 will significantly raise the bar for clinical data.
Among the new requirements:
A clinical evaluation plan and a clinical evaluation report is required for all device including class I.
The clinical evaluation shall follow a defined and methodological sound procedure and be based on MEDDEV 2.7.1/rev.4 and Annex XIV of the MDR
Especially related to the necessity to present sufficient clinical evidence to support the general safety and performance requirements
The clinical data should be sufficient to demonstrate compliance with the safety and performance requirements .
The clinical evaluation should include a critical evaluation of the results of all available clinical investigations whether positive or negative
The method of appraising the literature need to be documented to assure your critical evaluation, without any bias or underexposure of unfavorable data.
Consideration of currently available alternative treatment options for that purpose
State of the artagainst which to measure safety and performance must be established from Literature Review
In order to rely on clinical evidence of an similar device already marketed, the biological, technical and clinical equivalence will need to be demonstrated scientifically. Furthermore manufacturer will need to have sufficient access to design data of the t device with which he claims equivalence.
Results of clinical investigations and/or Post Marketing Clinical Follow Up Studies that you performed in the past or that are currently ongoing, will be very valuable for your clinical evaluation. Similarly results from your post market surveillance process including some form of active collection of data will also represent an important input into your clinical evaluation which will be part of your Technical Fileto be assessed by your Notified Body.
It is therefore urgent for all medical devices manufacturers to critically and objectively analyze the foundation of their Clinical Evaluation Report and assess whether they have clinically sufficient evidence for future MDR compliance? Some devices will surely lack sufficient clinical evidence and might indispensably require some form of active data collection (PMS/PMCF).
As EU Consultant, Obelis can help you understand the new requirements, perform a gap analysis, and assist you to develop a solid plan for clinical data compliance.
At Obelis, our mission is to provide our clients with the finest quality services and personalized solutions to the complex regulatory requirements throughout the world. Therefore, we have developed a wide range of solutions to provide you with support in over 20 markets worldwide. With Obelis, you get: