Keeping track of data relating to all products available on the European Market can be very difficult to say the least, and yet, from a compliance and regulatory standpoint, it’s a very, very important part of ensuring all products circulating throughout Europe are safe for use. For bodies on all parts of the supply chain (from manufacturers to distributors, retailers to consumers, and even the European Commission itself), having up-to-date access to information regarding products’ compliance status is paramount. In an effort to facilitate this efficient movement of information, the RAPEX system was created. Read more
What is RAPEX
I notified my own products within the CPNP
First introduced in January 2012, the Cosmetics Products Notification Portal (CPNP) is a European notification platform intended for submitting technical compliance related information regarding cosmetic products to conveniently convey to any relevant competent authorities that a cosmetic product is fully compliant with all concerned directives and regulations. Created under Regulation 1223/2009/EC, the CPNP aims at harmonizing cosmetics products within all EU Member States (including four EFTA countries) covered by the legislation. The regulation also makes CPNP notification a mandatory part of the compliance process for all cosmetic products seeking to enter the European Market. Read more
Already selling in Europe without a problem
In many cases it is possible for some products to have found their way onto the European Market without having undergone the proper Compliance screening processes or having been awarded an official CE Marking. In these types of cases, manufacturers may well feel that there is no real pull factor to encourage them to seek CE certification and that the onus to request information on such issues falls outside the realm of their responsibility. This, of course, is not the case. The most important thing to note in instances like these is simply that a product’s presence on the market does not imply compliance. Read more
What is COSMOS Certification?
Within the wide world of cosmetics, many different bodies exist with to the purpose of regulating the quality and standards for a large variety of products. Manufacturers or distributors seeking to enter certain markets, advertise in certain ways, or make certain claims about their cosmetics products sometimes encounter different bodies from whom they will need to receive compliance certification in order to assure distributors, markets and consumers of their legitimacy and safety. These are called ‘Authorised Bodies’. In the case of organic or natural cosmetic products in Europe, that authorized body is known as COSMOS. Read more
Updated Quality Management Requirements for OBL Manufacturers
A number of key changes in requirements for quality management processes that may affect several Original Brand Labelers (OBLs) have been introduced recently. The updates, affecting those operating in the fields of Medical Devices and In-Vitro Diagnostic Devices, mainly concern OBLs’ current auditing system and quality management practices – extending the boundaries and giving clearer, stricter guidelines for both.
For the sake of clarity it is worth outlining that the definition of an OBL is generally accepted as any company that receives equipment made by a manufacturer with the intent of repackaging or incorporating that equipment under its own brand name. As such, an OBL is generally the body expected to place a product on the market under its own name, brand, or trade name.
As part of the updated requirements, OBLs are obligated to facilitate a quality management system (QMS) that adheres to each requirement laid out in the relevant directive – MDD 93/42/EEC in the case of OBLs working with medical devices. It is worth noting that while this doesn’t necessarily mean that a fully compliant ISO13485 system is mandatory in each case, it would certainly simplify processes in terms of harmonised standards.
Included in the new QMS requirements, the following (at a minimum) must be included in a product’s documentation (to be assessed during annual audits):
- Traceability data
- Regulatory requirements (market surveillance, vigilance, etc.)
- Quality control data
- Organisational structure for the company (including roles and responsibilities)
- Quality objectives
- Internal audit information and documentation
- Management review
- Client communications and order-processing
- Manufacturing processes (including performance testing and non-conformity information)
- Corrective and preventative actions taken by the company
- Purchasing from and control of related parties (including Original Equipment Manufacturers and other suppliers)
OBLs dealing in Class IIb and Class III medical devices are also obligated to provide design processes within the updated quality management system documentation. It is important to note that OBLs are obligated to carry out each of these processes themselves and cannot delegate to an Original Equipment Manufacturer (OEM) or any other third party. Failure to do so can result in a range of consequences for the OBL, including loss of CE certification or destruction of the product in question.
In addition to regular annual audits, a series of unannounced audits will also be required by the new updates. These audits will be carried out at the place(s) where the devices in question are manufactured – in most cases these may be the premises of an OEM. The responsibility for all audit costs falls onto the OBL as the body responsible for introducing the product to the European Market. It is important to also note that non-compliance or refusal to undergo the full unannounced auditing process (by either the OEM or the OBL) can result in a suspension of the manufacturer’s CE certification.
For more information on the new updates to quality management requirements, to learn about Obelis’ CE Marking and Authorized Representative services, or for advice on compliance with European directives, contact our team of regulatory experts today!
Why Don’t Retailers Request Proof of Compliance?
The path to compliance can often be a long and confusing one full of roadblocks for manufacturers and distributors uninitiated to the intricacies of the process. In the case of manufacturers working within the boundaries of the General Product Safety Directive (GPSD 2001/95/EC), whose products would generally be consumer orientated and therefore open not just to the European Market but the general European public at large, many detrimental assumptions or errors due to lack of experience or knowledge can be made which can lead to any degree of safety risk to users of their product. Read more
Can I Piggyback on my OEMs CE Certificate?
In many ways, a CE Certificate is a passport to the European Market for any medical device. It provides definitive proof that manufacturers and their products adhere to all European compliance regulations and that all standards have been met at each stage of the production process. The certificate itself ensures only the highest quality, safest products reach the EU marketplace. It is, however, not just a badge of honour for manufacturers and products, it’s also a mandatory requirement for distribution and sales within Europe. This is true for both Original Equipment Manufacturers (OEMs) and Original Brand Labelers (OBLs). Read more
What is changing for IVD Classification under the new IVD Regulation?
Many manufacturers may very well already be feeling the benefits of the new EU IVD Regulation 2017/746. Approved on April 5th of this year, and in force as of May 26th, the new regulation did much to tackle previous issues felt by manufacturers and distributors alike struggling to introduce their IVD devices to the European Market on account of homogeneity in the scope of device classification. Read more
Consequences of Non-Compliance
Full adherence to all compliance-related matters is a hugely important part of introducing a product to the European Market – or indeed maintaining its position there. Each category of CE Marking certifiable product has its own set of regulations or directives, from medical devices to personal protective equipment to toys, and electromagnetic devices to construction products and motor vehicles.
The onus is entirely on the manufacturer to demonstrate that their product is in full compliance with the relevant essential EU directives and regulations – all of which must be adhered to in advance of a CE marking being initially affixed. Some directives also call for the appointment of a Notified Body to assess compliance or product-specific issues, though this is generally only the case with high risk or safety critical products. Read more
Can Safety Assessment be done in a lab outside of the EU?
The Safety Assessment procedure is a crucially important part of the cosmetics compliance process for all manufacturers and distributors seeking to introduce a cosmetic product to the European Market for the first time. Under Annex 1 of European Cosmetics Regulation EC 1223/2009, the safety assessment makes up an entire part (Part B) of the Product Information File – without either of which a product cannot be brought to any European member states.
When it comes to where and how the safety assessment procedure can be carried out, there are a couple of guidelines and conditions laid out in regulation EC 1223/2009 which can help manufacturers more easily navigate the compliance process. In this blog, we will outline the most important issues and conditions for manufacturers and distributors who wish to carry out their safety assessments outside the boundaries of a laboratory inside the European Union.
Can I use a CE Mark if I don’t sell in the EU?
A product’s CE marking is seen as the gold-standard in industry and consumer market quality in Europe. It stands as a mark of highest quality, rigorous testing, and to-the-letter compliance with strict health and safety codes and regulations. As a result of this, it is a huge testament to any product bearing it and leaves no room for questions as to why any manufacturer or distributor would want one for their product. It does, however, come with its own set of jurisdictional limitations. In this blog, we will explore CE marking’s role, or lack thereof, in allowing a product access to the global market. Read more
Is English Sufficient for my Instructions for Use?
Ensuring all relevant product information is communicated clearly is an extremely important part of the compliance and market entry process for medical devices. As a general rule of thumb, any information pertaining to the product and its intended use should be outlined in at least the native language of every country on the European Market it is being released to. Read more
What Needs to be Translated on a Cosmetic Label?
The labelling process for cosmetic products is relatively straight forward, even for products seeking to enter the European Market that may be manufactured or produced outside the European Union. One of the most fundamental aspects of the labelling process to note is that a product can only be labelled and released onto the European Market after all relevant safety assessments and tests have been made and after the Notification process and work on the Product Information File has been conducted and reviewed by the Responsible Person. Though this blog will focus on the aspects a cosmetic label that need to be translated, it will also outline the other items which must be included on the label too. Read more
Do I need a CE Marking if my OEM already has one?
Obtaining a CE Mark should be a primary target for any manufacturer seeking to introduce their product to the European Market. In many cases, CE Marking is a mandatory compliance requirement for products, and at the same time it makes the marketing of products far easier and more attractive to consumers as they are the hallmark of compliance with European harmonized standards. Read more
Cosmetic Distribution or Compliance: What comes first?
In an effort to hold the European cosmetics market to a higher standard of user safety, EU Regulation 1223/2009/EC has laid out an extensive and detailed series of rules and guidelines governing the processes each cosmetic product must go through before they can be released onto the European Market. As each of these steps must be adhered to for the product to be allowed onto the market, it is safe to say that the Compliance Process must always precede the distribution process.
Can my Distributor act as Responsible Person
In the field of cosmetic products, appointing a Responsible Person is a mandatory part of introducing any product to the European Market. As the Cosmetic Regulation EC 1223/2009 states: “only cosmetic products for which a legal or natural person is designated within the community as ‘responsible person’ shall be placed on the market” (Article 4.1).
Non-European companies cannot fulfil this role themselves, therefore they have to delegate this regulatory burden to another party. Many of them decide to work with one of their European distributors as Responsible Person. We must stress that this strategy is really risky and there are numerous long-term factors to take into consideration while choosing a Responsible Person: Read more
Which products fall under Personal Protective Equipment Directive PE 89/686/EEC
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
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.