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

Should I work with my importer to register my cosmetic products?

in Blog

According to European Regulation EC 1223/2009 (Article 4.1), “Only cosmetic products for which a legal or natural person is designated within the community as ‘responsible person’ shall be placed on the market.” This regulation can be the cause of much confusion when it comes to appointing or working with a fitting importer in the cosmetic products field. For example, its setting out of the mandatory obligation for manufacturers to designate a European Responsible Person  – a body whose duties would otherwise fall to the (potentially uninitiated) importer – can raise many questions surrounding the effectivity of importers as regulatory representatives. We will, in this post, address some of those questions. Read more


Cosmetics Notification in the EU: A How-To Guide

in Blog

Bringing a new cosmetic product to the European market can, in the minds of some, be a long and arduous process with many hurdles to leap over along the way. While, to ensure quality and safety standards are adhered to, there are certainly factors each manufacturer must comply with, being put off or intimidated by the whole process is simply unnecessary. In this blog, we will try to put some worries to rest on the issue of notification and the European market.

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What is a Medical Device according to MDD 93/42/EEC?

in Blog

After having defined and explained the Medical Device Classification System in our last blog post, it’s possible that one unexpected question has arisen – what actually is a medical device? In this blog post we will seek to answer that question.

Pining a definition to the term ‘medical device’ has never been easier since the introduction of Medical Device Directive 93/42/EEC. Introduced on June 14, 1998, and amended on September 5, 2007, the directive came into effect in March 2010 and established the essential requirements and harmonized standards for the manufacture, design, and packaging of medical devices. It is advisable, where possible, to pay close attention to the 2007 amendment as it contains an update on such industry changes as the definition of a medical device, things which are not considered a medical device, and the explanation of Member State’s role in the process. Such amendments became necessary due to rapid advancements in technology and the development of international initiatives. Read more


Basics of the Medical Device Classification System

in Blog

For many manufacturers in the industry, medical device classification can be a daunting task to say the least. Determining what device falls into what class, and what steps need to be taken afterwards to introduce the device to the European market can be difficult.

This blog will be a guide to the basics of the medical device classification system under the Medical Device Directive Annex IX and what restrictions exist at each class level.  Read more


How to Obtain a CE Mark (for a Medical Device)

in Blog

There’s a common misconception among many medical device manufacturers that obtaining a CE mark is too hard, too costly, and too complicated. We’re glad to be able to say that this isn’t true. With some knowledgeable guidance and the understanding that obtaining your CE mark is simply a process like any other, much of the undue stress and worry can be taken away.

In this blog entry we will walk through some of they key steps in obtaining a CE marking for medical devices – along with some necessary additional steps for manufacturers located outside of the European Union.

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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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