Covid tests under IVDR – How to sell them on the EU market?
The new EU Regulation on in vitro diagnostic devices (IVDR), applicable since May 26, 2022, affected the classification and compliance process of COVID-19 tests.
The LVD 2014/35/EU (Low Voltage Directive) of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits is entered into force on the 20th April 2016 replacing the previous Directive 2006/95/EC.
The Low Voltage Directive was one of the eight directives harmonised with NLF as a part of a so-called ’Alignment Package’.
The Low Voltage Directive ensures that electrical equipment provides a high level of protection of health and safety of persons, and of domestic animals and property.
Therefore, the Low Voltage Directive lays down the essential requirements to protect against hazards that could arise from within the electrical equipment itself or from external influences.
The term “electrical equipment” is not defined in the directive. It is to be interpreted according to the internationally recognized meaning of this term. The definition of electric equipment in the International Electro Technical Vocabulary of IEC (International Electro Technical Commission) is: “item used for such purposes as generation, conversion, transmission, distribution or utilization of electrical energy, such as machines, transformers, switchgear and control gear, measuring instruments, protective devices, wiring material, current-using equipment.”
The LVD Directive includes both electrical equipment and components designed for use with a voltage rating between 50 and 1000 V for alternating current (AC) or between 75 and 1500 V for direct current (DC). These voltage ratings refer to the voltage of the electrical input or output, not to voltages that may appear inside the equipment.
Equipment listed in Annex II LVD 2014/35/EU are excluded from the scope of the Directive:
In the main, these are items which are covered under other more specific directives or which are subject to international legislation outside of the jurisdiction of the EU.
Conformity assessment procedure (Annex III- Internal production control)
The manufacturer puts together the technical documentation which makes it possible to assess whether the electrical equipment complies with the requirements of the directive. It contains at least the elements set out in the Annex III.
The essential requirements
The essential requirements cover all risks arising from the use of electrical equipment, including not just electrical ones but also mechanical, chemical (such as, in particular, emission of aggressive substances), health aspects of noise and vibration, and ergonomic aspects which could cause hazard within the scope of the LVD Directive.
Evidently, non-compliant products enter the EU Market everyday – whether the brand owner knowingly does so or due to a lack of knowledge imparted from EU importers/distributors.
As there is no “approval” in the EU Market, Competent Authorities focus almost exclusively on conducting systematic surveillance of products which are being made available on the market. This can include pulling products off of shelves, stopping products at customs or even deploying bots online to identify non-EU based e-commerce shops which mention that they ship to the EU Market.
Should you choose to take the risk to ship product to Europe which has not followed the required path to compliance as detailed above, you should also be prepared for the consequences.
The main consequences include, but are not limited to:
Ultimately, the prescribed actions that are to be taken in the case that a product is found to be non-compliant will vary depending on the EU Competent Authority which identified the breach, the EU Member State, cooperation from the brand owner and the actions taken by the appointed Authorized Representative. Above all else, the professionalism and expertise of the appointed Authorized Representative in dealing with various Competent Authorities and handling such situations play a vital role in the successful recovery of your brand in the EU Market.
It is the responsibility of each brand owner to continue to collect information related to use of their products after they have been made available to consumers as well as to ensure that they continue to comply as the legislation applicable to their products evolves. Post-marketing surveillance activities include, but are not limited to:
Working with a professional Authorized Representative will help to ensure that the necessary actions are taken to ensure continued compliance and proper post-market surveillance.