FREQUENTLY ASKED QUESTIONS

I WOULD LIKE TO SELL FACE MASKS/RESPIRATORS IN EU - WHAT DO I NEED FOR THAT?

First of all - check the compliance to directives. Second - find and appoint your AR in EU. Third - register your product with Eudamed. For more detailed information - get in touch with us.

I WOULD LIKE TO REGISTER HAND SANITIZER - WHAT SHOULD I DO?

Regulatory framework

The regulatory framework that applies to a hand sanitiser depends largely on the ingredients and marketing claims made on the label. Typically, a hand sanitiser falls into one or both of the following regulations:

  • Regulation (EC) No 1223/2009 for Cosmetics

  • Regulation (EU) No 528/2012 for Biocides

How to comply with hand sanitiser regulations

 

Follow the step by step guide to help you comply with applicable regulations for hand sanitisers:

Step 1: Collate information on your product

Formulation

List your ingredients and CAS or EC number with corresponding quantities (%) in a table.

Documentation

Request the Safety Data Sheets (SDS), Certificates of Analysis (CoA), and efficacy lab testing documentation from suppliers. Any marketing claims such as “kills bacteria” or “kills viruses” should be supported by evidence (see next step).

Step 2: Marketing claims

 

Consider the marketing claims you wish to make on the label. The phrases and words that appear on your pack will determine which  regulatory framework applies and some terms will require additional lab testing. Phrases like ‘kills 99.99% bacteria’ require special hand sanitiser testing that conform to BS EN standards.

Avoid words that you cannot support with evidence and only claim ‘kills viruses’ if you have the evidence to back it up.

Words to mean cleaning, perfuming or protecting skin fall in scope of cosmetics regulation. Marketing claims will be assessed for validity in the next step.

Step 3: Submit your documents for compliance review

Compliance with Biocide regulations

Request a compliance review to ensure your hand sanitiser is compliant with biocidal regulations (EU) No 528/2012. We will check ingredients and labelling, among other things and advise on compliance status.

Safe to use as a skin product

Order a cosmetic safety assessment on your product to ensure the product is safe to use. The safety of the product will be assessed based on the ingredients, quantities and marketing claims, among other things.

Next Steps

 

Depending on the outcome of the compliance review, any of the following may apply:

  • registration as a biocide

  • notification as a cosmetic

  • premarket authorisation as a biocide

Note: Regulations differ slightly market to market.

1. Attitude - you are not just "another customer" 
2. Time - we value your and our time therefore no unnecessary paperwork, forms, long replies etc. 
3. Confidence - 100% result guarantee (if we agree to take your project)

HOW DO I KNOW THAT MEDEVICE GROUP IS THE RIGHT CONSULTING AGENCY FOR ME?