The June 1995 Personal Protective Equipment directive 89/686/EEC sets out the guidelines and regulations for all personal protective equipment seeking to enter the European Market. Under the directive, ‘personal protective equipment’ is defined as “any device to be worn or held by an individual for protection against one or more health and safety hazards”. The aim of the directive is to ensure the safeguarding of public health, improve the quality of work safety, and guarantee user protection and ultimately contributes to the European Commission’s goal of facilitating free movement of quality goods throughout the European Economic Area through the use of universal Harmonized Standards. Read more
Which products fall under Personal Protective Equipment Directive PE 89/686/EEC
What kind of testing do I need to do to register my cosmetics in the EU?
Product testing is an extremely important, and sometimes time consuming, part of the compliance process for a cosmetic product. It is a process that helps to prove the safety and standards of a product, which in turn facilitates the smooth compiling of the Product Information File. Fortunately, Cosmetics Regulation EC 1223/2009 helps to define each required test and what is expected of each product before it can enter the European Market. In this blog, we will outline and briefly explain the three main types of testing a cosmetics product must undergo before being registered in the EU under regulation EC 1223/2009. Read more
What is the compliance path for EMC & LVD products?
Being aware of the compliance path for each type of device is paramount when trying to bring a wide range of products to the European market. It is down to the manufacturer to determine the applicable standards and directives that apply to a given product before identifying the appropriate conformity assessment modules relating to the product classification. After this, a ‘quality system’ of post-market surveillance, vigilance, and traceability must be conducted continuously, along with risk analysis and safety assessment reports. In short, it is a rigorous process, and one that must be given due diligence. That is why, in this blog, we are going to try to clarify the compliance process for two product categories in particular – Electromagnetic Compatibility devices and Low Voltage Devices. Read more
Do I need a Responsible Person once my products are registered on the CPNP?
To paraphrase an adage, a Responsible Person is for life, not just for registration. The role of the Responsible Person has become absolutely crucial to almost every step of the cosmetic product manufacturing-to-distribution process. While it is true that to complete Cosmetic Product Notification Portal (CPNP) registration a Responsible Person (RP) is required, the role of the Responsible Person is far more diverse than that. In this blog, we will take a look at some of the duties the Responsible Person performs after the initial CPNP registration process and how they influence the importance of the role to the manufacturer. Read more
Basics of In-Vitro Diagnostic Medical Device Classification
For the uninitiated, understanding the basics of In-Vitro Diagnostic Medical Devices can be a confusing process. According to the 1998 medical device directive, IVDD 98/79/EC, an in-vitro diagnostic medical device (or IVD) is defined as “any medical device which is a reagent, reagent device, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination, intended by the manufacturer to be used in-vitro for the examination of specimens including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state of health or disease or congenital abnormality or to determine the safety and compatibility with potential recipients”. In essence, IVDs are tools used in the examining of human samples (blood, urine, tissue, etc.) outside of the body. They can be used to, amongst other things, help detect infections/diseases, monitor the progress of drug therapies, and diagnose conditions.
In this blog we will try to shed some light on the IVD classification process. IVDs are classified by potential risk to the user and fall into four main groups. They are as follows:
I. All Other Devices
This is a catch-all category used to define any device or equipment that doesn’t fall into any of the below categories. Most of the devices in this group tend to be intended for professional use, rather than personal or home use.
Example: Specimen receptacles (test tube, etc.)
II. Devices for Self-Testing Not Listed in Annex II
Devices in this category are those intended for home or personal use by untrained lay persons for self-testing.
Example: Home pregnancy test
III. Device of List B, Annex II
Devices in this category are those determined for professional use posing low risk to the user.
Examples: Reagents and reagent products for the detection of infections or diseases (such as rubella or chlamydia) in humans, reagents and reagent products for determining tumoral markers (such as Prostate-Specific Antigene), or devices for the measure of blood sugar.
IV. Device of List A, Annex II
Reagents and reagent products for the detection, confirmation, and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II (cancer causing), and Hepatitis B, C, and D.
It is very important to note that the IVDD 98/79/EC directive provides neither a specific list of affected devices, nor their corresponding classification, so the onus is on the manufacturer to determine which directives apply to which devices and proceed accordingly. The directive outlines only device requirements, as well as requirements for manufacturers, and device safety and compliance standards. Devices used in veterinary medicine or general laboratory use are not subject to directive requirements.
How long does it take to register a cosmetic product in the EU?
It isn’t always easy to determine just how long it takes to register a cosmetic product for release on the European Market. In some cases it can be a lengthy process, in others quite brief.
In general, the EU compliance process takes between 4-8 months. There are two main factors determining the timeline of the registration process:
- How ready the technical documentation (Product Information File) is
- If all the safety test have been done
In order to shed some more light on this, here we will outline some of the steps in the compliance stage which are crucial to shorten the timeline of the registration process. Read more
Do I need an EAR if I have a Notified Body?
Though both are involved in the EU Compliance process and CE Marking, a European Authorized Representative and a Notified Body are not mutually exclusive bodies. Both have roles unique to themselves throughout the EU Compliance procedure. In order to clear up a few common misconceptions regarding European Authorized Representatives (EAR) and Notified Bodies (NB), this blog will outline the definitions and roles of each in order to better further the understanding of what is required from manufacturers of certain medical devices. Read more
Why can’t my Safety Assessor act as Responsible Person?
The role of the Responsible Person is an absolutely pivotal one in the compliance and European Market distribution process. Many questions have arisen surrounding who or what bodies may perform the functions of the Responsible Person. The most important thing to know, at any stage, is that according to EU Cosmetics Regulation (Regulation (EC) No. 1223/2009): “Only cosmetic products for which a legal or natural person is designated within the community as ‘responsible person’ shall be placed on the market”. With this in mind, it is clear that the role of the Responsible Person is one to be taken seriously, and appointments should not be made lightly – especially not to organised bodies which may have limited industry knowledge or experience, or may have a role/skillset of their own already. Read more
Third-Party Producers and the European Market
There are many things to consider when introducing a product to the European Market for the first time. Right at the top of that list is: What is the background of my third-party producer and are there any barriers to their components entering the market?
As always, there are some steps that must be taken into consideration, especially when the manufacturers in question are themselves not located inside the European Union. In this blog, we will outline and answer some of the most pressing questions when it comes to third-party producers and the European Market. Read more
Should I work with my importer to register my cosmetic products?
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
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.