Meet Obelis Responsible Person representatives at exhibitions
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Meet Obelis European Authorized representatives at exhibitions
Evento

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ISO 9001:2015 – A New Approach!
News

After over three years of revision work and nearly 95 participating and observing countries, the new ISO 9001:2015 was published on September 23, 2015. This new approach has been released to respon [...]

BREXIT Explained!
News

Brexit – What happened? On June 23rd 2016, 52% of UK citizens voted in favour of the ‘Brexit’: Britain-Exit of the European Union. This vote comes following much political disagreement, primari [...]

Obelis Scientific Department Officially Launched!
News

On 1st September 2016, Obelis officially launched a new department within the company structure - the Scientific Department. It makes up part of the Compliancy Unit and complements the pre-existing R [...]

Blog

EAR for MDD I (non-measuring, non-sterile) products

in Blog

An E.A.R. or European Authorized Representative (sometimes known as an EC Rep or EC/CE Representative) is any person naturally or legally established in the European Community who is explicitly designated by the manufacturer to ensure compliance of their products. This person may be addressed by authorities and bodies within the European community, instead of the manufacturer themselves. In essence, an Authorized Representative is a legally required body for those located outside of the EU and looking to introduce medical devices to the European market.

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What is the CPNP?

in Blog

The Cosmetics Products Notification Portal (CPNP) is an online notification system for submitting certain technical compliance related information about cosmetic products. It was created for the implementation of Regulation (EC) No 1223/2009 on cosmetic products and aimed at harmonizing the 28 EU Member States + 4 EFTA countries covered under this legislation. Read more


What is Eudamed?

in Blog

Eudamed is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission. The portal cannot be accessed by the public. Eudamed came into force in May 2011 and was created with the purpose of strengthening market surveillance and transparency with regards to medical devices placed on the European market. Read more


Impact of the New Cosmetics Regulation

in Blog

 

 

The EU Cosmetics Regulation (Regulation (EC) No 1223/2009) has been in place for over three years since it replaced the old EU Cosmetics Directive 76/768/EEC. The regulation was introduced with the express purpose of simplifying and harmonizing the regulatory requirements across all member states while also upgrading the requirements placed on the Brand Owner. Read more


How Much Does CE Marking and Certification Cost?

in Blog

When it comes to obtaining the CE marking, one of the primary concerns for manufacturers is the financial costs involved in the process.

There are too many variables and factors to consider to be able give a uniform estimate of the costs of obtaining CE marking. However, with the right information, product manufacturers should be able to arrive at a reasonably accurate assessment of the expense involved. Read more


An Explanation of the Responsible Person

in Blog

Since the implementation of the Cosmetic Regulation EC 1223/2009 on July 11, 2013, each cosmetic product placed on the European market must now have a designated “Responsible Person”. Their job is to guarantee product compliance in front of the relevant European authorities, therefore ensuring that the product is safe for human health.

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What is the CE Marking Process?

in Blog

There is a fear among many product manufacturers that the process of obtaining CE Marking is long, complicated and expensive. This blog aims to examine how much truth and validity there is to that statement.

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What is CE Marking?

in Blog

There are often numerous misunderstandings concerning CE marking – who it is for, what it means and who needs it. This blog aims to unpick, debunk and clarify some of these misconceptions, starting with the basics.

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