Identifying product requirements
Coronavirus, medical supplies and protective equipment
- EN 149:2009 Respiratory protective devices – Filtering half masks to protect against particles - Requirements, testing, marking (commonly referred to as 'FFP masks')
- EN 14683:2019 EN Medical face masks - Requirements and test method
- EN 166:2001 Personal eye-protection – Specifications
- EN 14126:2003 Protective clothing - Performance requirements and tests methods for protective clothing against infective agents
- EN 14605:2009 Protective clothing against liquid chemicals - performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only
- EN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
- EN 13795-2:2019 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
- EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes (MDD)
- EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties (MMD)
- EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation (MDD)
- EN 455-4:2009 EN Medical gloves for single use - Part 4: Requirements and testing for shelf life determination (MDD)
- EN ISO 374-5:2017 Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks
- EN ISO 13688:2013 Protective clothing - General requirements
- EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
EU-wide standards and technical specifications exist for a number of product categories. You must ensure your products comply with any relevant EU rules before they can be traded freely in the EU.
Where no EU-wide rules exist, different specifications might apply in different EU countries. In such cases, you must only comply with the rules valid in your EU country.
What are product requirements?
EU law sets essential requirements to ensure products traded in the EU meet high health, safety, and environmental standards.
Requirements can cover:
the product itself: for example flammability, electrical properties or hygiene
the product's manufacturing process
the product's performance: for example, its energy efficiency.
In most cases, the law defines the results to be achieved or the hazards to be dealt with, but it does not specify technical solutions.
Sometimes harmonised standards can help you demonstrate conformity with the law.
Where to find EU product requirements
Currently, most of the product rules are harmonised in the EU. This means that the same rules apply in all EU countries. Rules are applied to product groups, such as toys, or product characteristics, such as electromagnetic compatibility.
You can check the requirements for your product in the Trade Helpdesk database.
The Trade Helpdesk database offers information on the:
rules and regulations for your product
competent authorities you can contact for specific product requirements
VAT and excise duty rates applied to your product in the EU country of sale
The Trade Helpdesk database is structured around custom codes: to view requirements for your product you will first have to identify its customs code. If you do not know the customs code, you can search for it with your product's name with the built-in search engine.
Where to find national product requirements
There are also product rules that are not harmonised in the EU, this means specifications might differ in each EU country. In such cases, you must only comply with the rules applicable in the EU country where you intend to place your product on the market.
If your products meet these requirements in your EU country, other EU countries cannot:
forbid the sale of your products
oblige you to modify them
make you undertake additional testing
unless they can prove that your products do not fulfil your country's technical and quality requirements and do not offer a similar level of safety. This is known as the principle of mutual recognition.
If you are facing a problem related to the product rules in another EU country being incompatible with the mutual recognition principle, you may request assistance from SOLVIT.
The governments of EU countries are obliged to publish their national rules. You can read more about national rules and the ‘mutual recognition' principle in the TRIS database for non-harmonised product rules.
In particular, the requirements under national rules might differ for the:
To find out which technical rules apply to specific products in each EU country or the details of competent authorities within that EU country you can contact the Product Contact Points.
Restrictions based on national rules
If your products pose a risk to the public interest, based on the laws in place in other EU countries that affect:
health and life of humans, animals or plants
public security or public morality
you may not be allowed to export them freely.
Your products could be banned if the EU country you want to export to can prove that its own technical requirements are essential or mandatory, and your products are not equivalent in terms of the level of safety sought.
To find out which national rules apply to specific products in each EU country or the details of competent authorities within that country you can contact the Product Contact Points.