European Union Classification of Medical Devices

Basically, there are three broad types of medical devices per European Union classification and the three (3) types of Medical Device Directives are below.

The following are the three Medical Device Directive (MDD) for all type of medical devices (1) in European Union.

·       93/42/EEC- Medical Device Directive

·       90/385/EEC- Active Implantable Medical Device Directive

·       98/79/EC – In Vitro Diagnostic Medical Devices Directive(2)

 For medical device which fall into 93/42/EEC and 90/385/EEC, It is prudent for manufacturer to perform a formal device classification per Annex IX of the MDD. In annex IX, there are information to help sponsor to classify the product. Just follow them.

Per 93/42/EEC- Medical Device Directive &  90/385/EEC- Active Implantable Medical Device Directive, there are Non-Sterile Class I Non-Measuring, Sterile Class Measuring, Class IIa, Class IIb and Class III.

For medical devices classified from Sterile Class I Measuring to Class III, medical device manufacturers require the implementation of Quality Management System (QMS) in accordance to Annex II and V of 93/42/EEC (1). Most companies or sponsors will apply ISO 13485 standard to achieve QMS compliance. 

Note: ISO 13485 is akin to 21 CFR 820 required in the US market. Both quality systems have overlapping quality requirements. Therefore, it is not uncommon for medical device companies to comply with both.

In fact, many multinational like Johnson & Johnson (J&J), Boston Scientific and Siemens willl comply to more than ISO 13485 and 21 CFR 820. They will have to comply with each regulatory and quality compliance of that country in question where the product has to be sold. For example, if J&J wants to sell its products in Australia, the products will have to be in compliance with quality system stupulated by Australia TGA.

What is the documents need to be filed with European Union? For Non-Sterile Class I Non-Measuring to Class IIa, sponsors require to prepare a technical file, while for Class III, it is called Design Dossier.

There are a little difference between EU and USA in term of interphasing with regulatory agencies. In US, the sponsors will have to directly deal with the FDA, while in European Union, sponsors need to appoint an Authorized Representative located in Europe which is qualified to handle any regulatory issues. Then the EC REP shall be placed on the Insturction For Use (IFU) or outer packaging or device label (1).

 Another concept is the Notified Body, it is a third party accredited by the European authorities to audit the sponsor QMS, technical file or Design Dossier.

 After Notified Body ‘approved’ the technical file and design dossier, the sponsor will be issued a CE Marking Certificate for the device. The notified body will audit ISO 13485 of the sponsor manufacturing capability. Assuming the manufacturing the medical device is top notch, ISO 13485 certificate will be issued to the sponsor. The ISO 13485 certiifcate must be renewed every year. CE Marking certificate are generally valid for three years (1).

  

1.     ---European Union The Medical Device Regulatory Approval Process, Emergo Group Chart, 03/2014 Updated.