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
As a manufacturer, you must carry out a risk analysis and ensure that your products comply with certain rules before placing them on the EU market.
This procedure is called a conformity assessment and it is carried out during both the design and production phase. Even if you subcontract the design or production of your products, it's still your responsibility to ensure that the conformity assessment is carried out.
The information obtained from the conformity assessment must be included in the technical documentation.
How to demonstrate compliance with EU rules
You should check if there are any EU rules applicable to your product, if there are, you must ensure your product complies with them before it can be traded freely in the EU.
Harmonised standards, where they exist, can help you demonstrate compliance with EU rules.
What are harmonised standards?
Harmonised standards are developed by recognised European Standards Organisations: CEN, CENELEC, or ETSI. Following harmonised standards in the design and manufacture of your products will ensure your products are in line with corresponding EU rules; this is known as ‘presumption of conformity'.
Do you have to follow harmonised standards?
No, the use of harmonised standards remains voluntary. You are free to choose another technical solution to demonstrate compliance with the mandatory legal requirements.
If you choose not to follow harmonised standards in your assessment, you can prove compliance by referring to technical specifications such as national standards, non-harmonised European and international standards, or your own technical specifications. In these cases, you will have to provide more details in your technical documentation explaining how your products comply with legal requirements.
Assessing the conformity of your products
In some cases, you - as a manufacturer - can make a self-assessment of your product, in other cases, you will need to involve a conformity assessment organisation (also known as a notified body) to assist you.
You should check the relevant EU legislation related to the products you want to assess to see if you need to request assistance.
Conformity assessment organisations
These notified bodies are organisations designated by EU countries to assess the conformity of certain products before they can be placed on the market.
You can choose a notified body from the list on the NANDO website (New Approach Notified and Designated Organisations).
Doing the conformity assessment yourself
If your product doesn't need to be verified by an independent body, it is up to you to perform the conformity assessment of your product. This includes estimating and documenting the possible risks when using your product.
Compiling the technical documentation
Your technical dossier should include all the documents that prove that your product complies with the technical requirements. Find out how to compile the technical documentation.