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
Should I work with my importer to register my cosmetic products?
Cosmetics Notification in the EU: A How-To Guide
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.
What is a Medical Device according to MDD 93/42/EEC?
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
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.
How to Obtain a CE Mark (for a Medical Device)
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.
EAR for MDD I (non-measuring, non-sterile) products
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.
What is the CPNP?
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?
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
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?
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
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.
What is the CE Marking Process?
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.