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2020-04-21

Guidance on surgical mask and repository devices (updated)

Remarkable Regulatory

Introduction

So much confusion. So many failed attempts to bring products to the market. So many questions left unanswered. Therefore we had to create a clear and understandable guide.

Summary

We launched it two weeks ago and instantly received fantastic feedback from within retail and trade, international manufacturers, Notified Bodies and even from authorities. Thank you all very much for that!

You also contacted us with more detailed questions. We did our best to answer them in version 2, now available for download!

Fake masks. Fake approvals. Rejected respiratory devices. Shortages. Alternative routes to the market. It is time for an understandable overview of what is going on in the world of medical masks and respiratory protective devices.

First, you need to understand how health workers are using these products when they are saving lives. From that, you will understand why specific standards and procedures are relevant. To provide the market with compliant products is always important. For health workers using these products today, it is a matter of life and death!

You will find the answers you are looking for in the PRODUCTIP GUIDE FOR SUPPLYING THE EU MARKET WITH SURGICAL MASKS AND OR RESPIRATORY DEVICES.

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