BY MIGUEL OHN, C.O.O. Obelis s.a,
On September 21, 2007 the directive 2007/47/EC of the European parliament and of the Council of September 5, 2007 was published in the official journal of the European Union. This directive amends the directives MDD 93/42/EEC (medical devices), AIMDD 93/385/EC (active implantable medical devices) and the Directive 98/8/EC on biocidal products.
The first amendment concerning the MDD 93/42/EEC states that “it is necessary to introduce an obligation for [such] manufacturers to designate an authorized representative for all classes of devices” (Amendment 18 Recital 14). This is a major clarification confirming the obligation of Non-EU manufacturers who do NOT have a legal identity within the EU territory to appoint one for all classes of medical devices.
It is important for a non-EU manufacturer to not only understand the amendments to the directives, but also their responsibilities for all the directives pertaining to their products. This article continues by outlining the steps that manufacturers must know in order to comply with the European regulations.
The first step for a Non-European manufacturer will be to appoint a European Authorized representative. A European Authorized Representative serves as a legal identity designated within the EU by the manufacturer, acting on behalf of the manufacturer as a central EU vigilance and contact point in the community. The second step is to identify which categories your products fall under because certain products require you to appoint an Authorized Representative as well as a Notified Body.
The notified body is a certification organization designated by the national authority of any EC country, which is authorized to conduct conformity assessments in accordance with the procedures in the directive. The notified body offers its services to the manufacturer with the aim to have the manufacturer's product put on the European market in conformity with the directives. The notified body performs its activities in a competent, neutral, independent and non-discriminatory manner. The European Commission assigned an identification number to each designated notified body. A Notified Body plays an important role in the procedure for obtaining a CE marking for devices in classes IIa, IIb and III and for class I products placed on the market in sterile condition and/or with a measuring function.
The following products require Non-European Manufacturers to appoint a European Authorized Representative: MDD products Class I non sterile devices and IVD products self declaration products.
For Class I sterile and measuring function devices, Class IIa, IIb and III as well as self testing or performance evaluation products, you will need to have both an authorized representative and a notified body.
After correctly classifying your product according to the essential requirements in the directives, (which is a service that Obelis European Authorized Center provides for free), you must take several more steps to prepare your product for sale within Europe. Upon classification, you will need to:
1) Identify the appropriate conformity assessment route
2) Prepare a product Technical File, including a product user manual. The technical file must include a general description of the products, design drawings, manufacturing methods and diagrams of components, sub-assemblies, circuits etc. with explanations, the risk analysis results, the design calculations and inspections results, as well as test reports and label and instructions for use. (It is important to note there will be more requirements depending on which class your product falls into).
3) The management will create a “vendor’s endorsement”
4) Determine the applicable standards - European, International or National
5) If required, choose a Notified Body to perform the official conformity assessments tasks in accordance with procedures in the Directives.
6) For selected types of devices, the European Authorized Representative must notify the product to the Competent Authorities (MDD class I and all IVD products)
7) Determine the proper labeling method based on applicable directives.
8) Assemble the required approvals and certificates and prepare an EC Declaration of Conformity per product according to the applicable Directives.
9) Affix the CE Marking in accordance with the European Directives.
10) The Manufacturer/European Authorized Representative must make the technical documentation, including the Declaration of Conformity, available to the European Authorities for inspection purposes, for at least five to ten years after the last product has been manufactured.
11) The manufacturer must institute and keep up-to-date systematic procedures to review the experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective actions, taking into account the nature and risks in relation to the product.
12) The manufacturer must also immediately notify the European Competent Authorities (via the European Authorized Representative) of the following incidents:
i. Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in their state of health;
ii. Any technical or medical reason connected with the characteristics on the performance of a device for the reasons referred in the Directive leading to systematic recall of devices of the same type by the manufacturer. Note: If a CE approved product causes any of these incidences OUTSIDE the European Union, you must report such incidents to the European Authorities (via the European Authorized Representative).
The requirements and responsibilities for manufacturers with regards to CE marking and the European directives can be quite complex but it is an important and relevant issue for the medical device industry today. Please visit us at www.obelis.net to find out more about this topic and to receive assistance for CE marking and other essential services.