Coronavirus (COVID-19): a focus on Class I Medical Devices Compliance

Coronavirus (COVID-19): a focus on Class I Medical Devices Compliance

In the last months, many Class I medical Devices, like Facial Masks, rapidly became the most researched items on the EU and Worldwide markets.

The products went shortly out of stock, resulting in a huge shortage and in a sensitive raise in price – causing big concern among the worldwide population.

Despite many difficulties, the industry immediately reacted with an increase in the production. Luckily, compliance for Class I medical devices is very easy to ensure, as you can see from next steps.


- Following the MDD Directive 93/42/EEC

  1. You - as a Non-EU manufacturer - must appoint a professional European Authorized Representative, such as Obelis.

This will allow you to have an EU registered address where Authorities can always have easy access to the technical documentation of your Devices.

2.  Obelis - as you EAR - reviews Technical documentation (mainly DOC and Labels + IFUS) and notifies the Belgian Competent Authorities.

Already next day, you will be able to affix the CE mark and enter the EU Single Market

Thanks to our Expedited service options, the whole process can be achieved in only 6 working days.

In addition:

3.  EAR registers your devices in the Member States that require an additional national registration (in Italy, Bulgaria, Greece, Latvia and Slovakia - depending where you plan to market – this can be done on behalf of both Non-EU manufacturers and EU Distributors).

4.  Free Sales Certificates application that will allow you to market your devices in the rest of the world (e.g. Iran, Taiwan, Japan, Thailand etc.)


09.04.2020

Davide Turchi

Regulatory Affairs Department


So, if you are a non-EU company Manufacturing facial masks, or any other Class I medical device, please contact us now and we will help you to quickly reach both the EU and Worldwide markets, ensuring millions of people will stay safe and protected.

Get in touch