What is the role of a Notified Body in the EU for testing products? Are testing labs and Notified Bodies the same entity?
The manufacturing of Personal Protective Equipment (PPE) is at an all time high, as we are living in the middle of a pandemic, caused by a highly contagious virus. PPE are gears that individuals use to protect themselves from the hazardous environment they are in. This could mean equipment that would protect the user’s skin, eyes, hearing, etc. One example is chap pants, the sturdy pieces of clothing that are worn by chainsaw users to protect their legs. Those same workers might also wear protective goggles or visors that keep wood shavings, dust and other particles out of their eyes while working on a construction site. For all of these vital pieces of protective gear, it is essential that they offer the protection that users are expecting from them. In order to make sure that all EU requirements are met, the company that places a PPE product on the EU market must follow a conformity assessment procedure first. Often this procedure requires PPE products to go through a series of tests and get the approval of an EU Notified Body (NB) before being circulated in the EU.
Notified Bodies and testing labs
A Notified Body is an organisation that is designated by an EU member state (or a state that has a Mutual Recognition Agreement with the EU) to assess product conformity with EU legislation, i.e. ensure that the products meet the criteria they need to, in order to be allowed in the market. This often involves issuing a certificate.
A testing laboratory, on the other hand, carries out the required tests on products, often on behalf of a Notified Body. Sometimes a testing lab and a Notified Body can coexist under the same roof, even though they are two different entities. Other Notified Bodies do not have inhouse testing labs and work with external partners. For example, a Notified Body in Germany could have a partner lab in China to ensure sufficient testing capacities. There are also Notified Bodies that do not organize testing themselves, but ask applicants for a test report from an accredited laboratory.
Services offered by Notified Bodies for PPE
The PPE Regulation defines three categories of PPE: low risk or simple PPE, medium risk or intermediate PPE, and high risk or complex PPE. PPE from the third category require the involvement of a Notified Body, which can, among others, provide the following services:
- EU type examination: In the EU type examination, a Notified Body examines, verifies and attests that the technical design of the PPE meets the requirements of the regulation that applies to it. This particular examination is carried out by assessing the adequacy of the PPE’s technical design examination of technical documentations, examination of a specimen, representative of the production envisaged, of the complete PPE. To apply for this, companies must hand in a written declaration saying that the same application has not been submitted with any other Notified Body. As part of the examination, the NB may make sure the PPE’s description of measures is accurate, check if the specimens are in accordance with the technical documentations and eventually issue a type examination certificate.
- Quality assurance of the production process: In order to make sure that PPE products are manufactured with consistent quality, NBs may also check the production process of the company placing the PPE on the market. Often, these companies have quality management systems (QMS) in place, and they usually keep protocols of the production history. The NB may check the QMS handbook, protocols, other documents as well as the company’s actual processes in an audit. The applicant also needs to keep the Notified Body informed about any changes made in the QMS for the PPE production.
- Supervised product checks at random intervals: For many PPE, it is possible to request supervised product checks at random intervals from a Notified Body instead of checking the QMS system as described in the previous paragraph. These usually happen once a year, and an agreement about them has to be made prior to the circulation of the product in the market. The Notified Body then carries out the product checks in order to verify the uniformity of production and the adherence of the PPE with the type described in the EU type-examination certificate, and with the respective health and safety requirements.
How to find a Notified Body or testing lab
Even if the company placing a PPE product on the market knows exactly which category the PPE belongs to and which testing standards are relevant for it, it is usually not an easy task to find a suitable testing lab or a suitable Notified Body for the PPE certification. One relatively easy way is to submit a free request using the online platform testxchange. Once this is done, users can either be contacted by Notified Bodies and labs directly, or the testxchange contracting team can make them an offer for the services needed. Thanks to the free online dashboard of the platform, it is also easy to monitor the testing and certification process, and communicate with the service provider in an easy and organized way. This way, all communication gaps between the two sides are eliminated.