There is a number of specific weaknesses in the CE marking system that have been identified, and which could explain why products that don’t comply with the European legislation are sold on the single market. These weaknesses are, as follows:
- Limited knowledge of both, substantial and complex, bodies of the EU legislation – It is especially noticeable in small firms and start-ups. The lack of knowledge, combined with the insufficiency of the financial resources for using harmonised standards, can lead to the creation of an entry market barrier.
- Relatively high cost of complying with CE marking legislation – The CE marking costs represent around 15-20% of the companies’ aggregate HRM expenditure and impact their competitiveness. As overall, inexperienced companies struggle with identifying and implementing the CE directives and standards relative to their products.
- Existing standards do not necessarily cover innovative products – Currently, not all innovative products and designs are covered by the existing EU legislation on CE marking.
- Shortcomings in the performance of notified bodies within the EU – the disparities in the quality of notified bodies and their independence from manufacturers were questioned by the European Commission and were the cause for the recent drop in the number of notified bodies involved in the assessment of high-risk medical devices.
- Inaccurate database of the notified bodies – The information held on nearly half of the notified bodies included in the NANDO database (approx. 800 of the total of 1700 notified bodies) was found to be out of date, incomplete or unclear.
- Difficulties in assessing the conformity of products bought in other countries.
- Cost of testing may be high – Many manufacturers need to outsource the testing activities to external laboratories and pay a higher price due to the lack of resources to afford all expensive lab equipment needed. The higher costs further stimulate producers to make risk assessments where they compare the cost with the risk of accidents occurring or the market surveillance authority ordering an inspection.
- Lack of transparency about the manufacturing process due to competitive reasons – Many manufacturers are afraid that their competitors will try to use it against them if they disclose important details about the product’s production process.
- China Export logo looks like the CE marking – Due to the similarities in both marks, consumers can get confused about the compliance of a product.