EU Medical Device Classification

This first blog is about European Union (EU) medical device classification. EU medical device classification is mainly classified into three main categories and governed by the following three directives.

1.     Medical Devices Directive (MDD): 93/42/EEC

2.     In Vitro Diagnostic Directive (IVDD): 98/79/EC

3.     Active Implantable Medical Device (AIMDD): 90/385/EEC

In order to market medical device into the EU, medical device company has to obtain a CE marking, generally. A CE certification is basically to verify that the device in question meets one of the above directives: MDD: 93/42/EEC, IVDD): 98/79/EC and AIMDD): 90/385/EEC.

Assuming you are a regulatory affair and marketing department director of medical device sponsor, the following steps should be followed to market your product into EU market.

1.     Determine which of the above three directives apply to your device.

2.     Perform a detail device classification according to the above three directives. For example, using Annex IX of the Medical Devices. Please be aware that each directive has their own sub-classes. For example, in MDD 93/42/EEC, there are Class I non-sterile and non-measuring, Class I Sterile and Measuring, Class IIa, Class IIb and Class III.

3.     Implement a Quality Management System (QMS) in according to Annex II or V of MDD. Most device companies apply the ISO 13485 standard to achieve the QMS compliance. Device also has to be in compliance with risk management of ISO 14971. Generally speaking, many companies implement other quality system like US FDA 21 CFR 820 or perhaps also comply with Korean Food and Drug Administration (kFDA) as well.

In this day and age of globalized economy, it is best that you should think of other markets as well, not only US and EU, but the rest of the world.

4.     Depending on the classification, prepare a technical file or technical dossier (Class III). In preparation of a technical file and dossier is very involved and must be planned ahead of them. It requires a lot of testing and planning.

5.     The next step is to appoint an Authorized Representative (EC Rep) located in Europe. This is the group who can handle regulatory issues or perhaps guide and coach you in the EU market. Then, you can place the EC REP name and address on the Instruction for Use (IFU).

6.     Except for the Class I (non-sterile and non-measuring), your QMS, Technical File and Design Dossier must be audited by a Notified Body. A Notified Body is a third party accredited by the EU to audit medical device companies and product. This is a little different from US which the FDA will audit the quality system. Examples of Notified Bodies are TUV SUD, BSI, TUV Rheinland and National Standards Authority of Ireland (NSAI).

7.     Except for Class I (non-sterile and non-measuring), EU CE marking certificate for your device will be issued (CE certificates are typically valid for 3 years from the date of issuance). ISO 13485 certification can also be issued and it has to be renewed every year.

8.     Prepare a Declaration of Conformity. Declaration of Conformity is basically a legally binding document prepared by the device manufacturing to state that the device is in compliance with the applicable Directive. Then you may affix the CE Marking on your product or packaging insert.

                         Courtesy of www.ec.europa.eu

98/79/EC	In Vitro Diagnostic Directive
93/42/EEC	Medical Devices Directive
90/385/EEC	Active Implantable Medical Device

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.