CE Consulting Medical Devices

The general process of medical device CE marking Certification and procedures often follow a certain pattern, the minimum requirement for CE marking is through the self-certification process (Class I devices). Even if a Notified Body was involved or not, every manufacturer has to fulfil both the essential requirements in accordance with Annex 1 and every manufacturer has to complete a Declaration of Conformity in accordance with Annex VII. Manufacturers that are not situated in the EU have to apply for CE marking via an Authorised Representative in accordance with Article 14.2 of the Medical Device Directive (93/42/EEC) + IVD Directive (98/79/EC, Article 1 §29). The registration is performed using the DIMDI (German Institute for Medical Documentation and Information) databank system. This databank can only be used by Authorised Representatives or by manufacturers that have a registered place of business in the EU. The DIMDI databank system is using similar to the Universal Medical Device Nomenclature System (UMDNS), which provides a common basis for device classification.

With the new regulations 2017/745 and 2017/746 on medical devices (MDR) and in vitro diagnostic medical devices (IVDR) replacing the Medical Devices Directive (MDD) and In Vitro Diagnostic Devices Directive (IVDD) the above mentioned process basically remains the same. There are, however, many changes and challenges. Please see the corresponding sections below for further details.

One additional problem is that registered trade names and trade marks might not be accepted in a different country, for example CE Marking in the US it is not going to necessarily be recognised in the EU. Larger manufacturers are rarely asked to provide their European distributors or end users with proof of CE compliance, they are seldom called upon to provide evidence of registration, however smaller manufacturers that work via an Authorised Representative are required to provide this evidence.

The DIMDI database is not the only hurdle that manufacturers have to get across, after they have successfully completed a suitable conformity assessment procedure in accordance with the relevant directives, the manufacturer must then gather the various directives, standards and guidance documents needed to demonstrate compliance.

Final compliance with the directives does not mean that the finishing line has been crossed. Standards are revised constantly and those manufacturers who do not actively take part in these revisions will find it impossible to keep up to date. Small overseas companies manufacture a large percentage of medical devices; if competent authorities fail to understand the unique needs of these manufacturers there is the possibility that an important source of medical supplies will be lost.

MDR – Medical Devices Regulation 2017/745

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Learn more…

IVDR – In Vitro Diagnostic Medical Devices Regulation 2017/746

REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Learn more…

Active Implantable Medical Device Directive No. 90/385/EEC (2007/47/EEC respectively)

The Active Medical Device Directive gives manufacturers the opportunity to develop their own compliance program. We guide you through the entire process and assist to optimize your compliance program to meet your product specifications and business needs. Learn more…

Medical Device Directive No. 93/42/EEC (2007/47/EEC respectively)

The Medical Device Directive gives manufacturers the opportunity to develop their own compliance program. We guide you through the entire process and assist to optimize your compliance program to meet your product specifications and business needs. Learn more…

In-Vitro Diagnostics Directive No. 98/79/EC

The In-Vitro-Diagnostic Medical Device Directive offers multiple routes to compliance – depending on the specifications and intended purpose of use of your product.

mdi Europa guides you through the entire process and assists to optimize your compliance program to meet your product specifications and business needs. Learn more…

Technical File Compilation

A Technical File is required for all products falling under one of the three medical device Directives, including low risk Class I and custom made devices. mdi Europa will help you to comply with the necessary legislation and assist in ensuring that your Technical File is ready for review by a Notified Body (as and when necessary) or the local Competent Authorities in Europe.

Ask for our checklist or request a quotation for Technical File compilation assistance. mdi Europa will make your life easier – at a cost effective price. Learn more…

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