Medical Device Link.

Originally Published IVD Technology September 2003

IVD Directive

In Germany, the competent authorities that record and evaluate incident and recall notifications for IVDs are the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institute (PEI). PEI is only responsible for certain high-risk products, namely those listed in Annex II of the IVD Directive, that are related to infectious diseases or those that will be used for safety or compatibility testing of blood or tissue donations. These products are not included in the following analysis.

From 1999 to 2002, a total of 121 reports have been registered by BfArM. In the beginning of this period, many of the reports were not related to CE marked devices, as CE marking was not possible until June 2000 and there is a transitional period for manufacturers until December 2003. The number of reports has been rapidly increasing in 2003.

Figure 1. Sources of incident, near-incident, and recall notifications.

More than one third (36%) of the total number of reports were sent in by manufacturers, 12% by professional users (mainly related to professional-use products), and about 15% by lay users or pharmacies (over-the-counter [OTC] products). Competent authorities of other member states sent 16% of the reports. The remaining 21% were sent by other sources, including national competent authorities, which forwarded a considerable number of reports related to non–CE marked products that they had received on the basis of the national legislation that preceded transposition of the directive (see Figure 1).

About 35% of the reports received were related to products for use by laypersons, i.e., OTC products. The remainder referred to professional-use devices. 

Figure 2. Over-the-counter product categories affected (Click to enlarge).

The vast majority (36 of 43) of the reports related to OTC products were filed for blood glucose monitoring devices (instruments and test strips). Other product categories affected were coagulation tests (2 reports) and pregnancy tests (4 reports). One additional case referred to a test for self-diagnosis of myocardial infarction (see Figure 2).

A product defect was verified in 13 of 43 cases, mainly due to production and packaging failures related to test strips (10 of 43 cases). Furthermore, there was a software problem, an electrical failure, and an inaccuracy in the instructions for use. In total, 10 of 43 cases have led to corrective action.

Reports regarding professional-use products covered almost all relevant types of IVDs and there was no major focus on a particular category of products (see Figure 3). 

Figure 3. Professional-use product categories affected (Click to enlarge).

A product defect (e.g., deviations in performance, interferences, cross-reactivity, stability problems, contamination, production and packaging errors, labeling deficiencies, software failures, or electrical hazard) could be confirmed in most of the cases (65 of 78). Considering the skills and experience of professional users, this is not surprising.

In 61 of 78 cases, corrective action was performed by the manufacturers. No measures were deemed necessary in 17 of the reported cases. This correlates with the high proportion of confirmed product defects. 

Corrective measures taken for both categories, OTC and professional-use products, included recalls, customer information letters, changes in production, design modifications including software upgrades, and modifications of the instructions for use or product labeling.


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