CE Marking Services and EU Regulatory Consultants http://obelis.net Obelis Group Mon, 18 Feb 2019 10:12:53 +0000 en-US hourly 1 https://wordpress.org/?v=4.9.9 Dr. Janette Benaddi http://obelis.net/dr-janette-benaddi/ Mon, 11 Feb 2019 13:14:55 +0000 http://obelis.net/?p=4945 Janette Benaddi is a business mentor, international speaker, author and consultant to the life science industry.  Janette has over 20 years’ experience in the field of medical devices including regulatory and clinical affairs.

In 1998 she setup and grew a very successful medical device consultancy, which she later sold in 2013. Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles during her career in the industry.  She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.

Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, she holds a teaching certificate and is a Chartered Scientist and Chartered Director. She also has an honorary doctorate in health sciences.  Janette is a seasoned non-executive Director and sits on the board of several medical device and other industry companies.

Obelis UK Ltd established! http://obelis.net/obelis-uk-ltd-established/ Fri, 11 Jan 2019 12:30:45 +0000 http://obelis.net/?p=4601 We are happy to inform you that on 27th of December Obelis has officially established a new company in the UK – Obelis UK Ltd. The purpose of this company is to serve as a UK Responsible Person for our clients, who will need a representative in the UK in the case of a ‘no deal’ Brexit.

Obelis is making steady progress towards answering the future challenges and fulfilling our strategic objective for 2020 – becoming the consultant of choice by shaping the compliance industry and providing the most effective compliance process.

We believe that with this new project we are going to provide an outstanding service to our clients, allowing them to have access not only to the EU, but also the UK market.

Obelis visits Tokyo! http://obelis.net/obelis-visits-tokyo/ Tue, 10 Jul 2018 08:46:01 +0000 http://obelis.net/?p=4072 From 14 – 16 May 2018, the Obelis team of Experts visited Tokyo, Japan, to get to know our clients better. During our stay in Japan, Obelis exhibited at the prominent cosmetics show “Beautyworld Japan” in Tokyo, where we met many of our clients, as well as 600 other cosmetic exhibitors and more than 76.000 Japanese as well as international visitors.


The Exhibition

Our C.O.O., Mr. Doram Elkayam (left), our Senior Consultant, Ms. José Amsing (centre), and one of our Junior Consultants, Ms. Martina Quitadamo (right), spent three days meeting with Obelis clients and discussing the compliance of their products in the EU, while also meeting with Japanese manufacturers of cosmetic products planning to enter the European market.


Export to Europe

If you would also like to meet with Obelis Experts in person and talk about safeguarding your products’ compliance on the European market, don’t hesitate to contact us – or take a look at our calendar and find out where you can meet us next!





Transitioning to ISO 9001:2015 & 14001:2015 http://obelis.net/transitioning-to-iso-90012015-140012015/ Mon, 28 May 2018 13:14:05 +0000 http://obelis.net/?p=3644 The ISO 9001:2008 and ISO 14001:2004 are being replaced by new standards as of September 2018.

The revision of both standards was published by the International Organization for Standardization in September 2015 with a three-year transitional period.

The most important changes are related to:

  • ISO 9001:2015
    • Leadership engagement
    • More effective management of the supply chain
    • More organized manner based on common ISO structure and simplified language
    • Organizational risks


  • ISO 14001:2015
    • High level structure according to ISO Annex SL
    • More detailed environment obligations
    • Higher focus on the quality management side of the environmental goals


All the certificates issued under the previous standard will become obsolete at the end of September 2018, and the responsibility concerning the recertification falls on the manufactures. In order to obtain a new certification, manufacturers need to contact their certifying institutions and comply with the new quality management and environmental requirements.

If you wish to know more about changes brought about by new ISO standards, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will gladly answer any question you may have.

Szymon Nowak-Rogozinski ]]> Brexit & EU product legislation: What to expect? http://obelis.net/brexit-eu-product-legislation-what-to-expect/ Tue, 10 Apr 2018 14:36:13 +0000 http://obelis.net/?p=3349 Undoubtedly, the departure of the UK from the European Union (EU) will cause a major shift in the industry sector and the related EU product legislation.

On 19th January 2018, the European Commission published an official Notice to Stakeholders [Withdrawal of the United Kingdom and EU rules on company law] presenting the new rules on company law in reference to the withdrawal of the UK from the European Union.

After the withdrawal date – 30 March 2019 – as referred in the Notice and if no congruent agreement will be drawn between the parties – the UK will be considered as a ‘’a third country’’ bringing significant changes for:

Economic operators

  • Manufacturers or importers established in the UK will no longer be considered as economic operators established in the EU;
  • UK manufacturers of medical devices or cosmetics will need to designate an authorised representative or responsible person based in the EU;
  • An authorised representative / responsible person established in the UK will no longer be qualified as an EU authorised representative / responsible person;
  • EU Distributors will become “importers’’ and will need to comply with legal obligations specific to importers.

Notified Bodies
and Conformity Assessment Procedures

  • UK Notified Bodies will no longer be eligible to perform conformity assessment procedures and will be removed from the NANDO website!
  • Certificates issued by the UK Notified Body – before the withdrawal date – can remain valid if a contractual arrangement is concluded between the manufacturer, the UK Notified Body, and an EU Notified Body (‘’transfer of responsibility to an EU Notified Body’’).

Manufacturers placing medical devices, IVDs, cosmetics and other products[1] on the EU market, having either a registered address in the UK or an Authorized Representative in the UK will need to take preventive actions in reference to these changes – such as designating a NEW Authorized Representative which has a registered address in the European Union. Contact us today to receive hands-on support on creating your BREXIT strategy.

Ajda Mihelčič

[1]  Annex to the Notice to Stakeholders presents an indicative list of all the affected EU product legislation. ]]> Authorized Representative: Higher Liability affecting Agreement http://obelis.net/authorized-representative-higher-liability-affecting-agreement/ Wed, 28 Feb 2018 08:00:15 +0000 http://obelis.net/?p=3210

Ever since the introduction of the mandatory requirement of an European Authorized Representative (EAR) for any manufacturer based outside of the European Union looking to introduce products to the European market under General Product Safety Directive 2001/95/EC, many manufacturers have been expressing concerns on what the accepted limits, boundaries, and responsibilities are in the relationship between manufacturer and EAR. One of the most fundamental aspects to understand when working with a European Authorized Representative to bring your products to the European Market is knowing what obligations fall upon you as a manufacturer and what information and documentation must be supplied to and handled by your EAR. Understanding the basics in this way can help keep liability on the correct party and avoid unnecessary complications in the relationship which may be problematic down the line.

To understand which obligations are on which party, it is first important to understand the function of the Authorized Representative. GPSD 2001/95/EC, introduced on January 15, 2004, established in law the requirement for any manufacturer based outside the European Union to elicit the services of an Authorized Representative to handle their interests inside the European Union. The idea is to achieve greater consumer safety, as well as increase transparency and harmonization on the EU market. The duties of an EAR can include:

  • Providing the manufacturer with a registered address in the European Union
  • Making all relevant technical documentation available for inspection by the European Authorities
  • Completing the notification process to European Authorities
  • Completing registration processes to national databases when necessary
  • Incident reporting
  • Representing the manufacturer towards the European Commission, Authorities and Notified Bodies
  • Safeguarding compliance with constant regulatory update
  • Consulting and advising the manufacturer on European Regulations


While all the above duties fall upon the EAR, according to Directive 2001/95/EC, it is important to note that the actual process of ensuring all products are in full compliance with the directive (and any other applicable European directive) are entirely on the manufacturer and all penalties or repercussions of non-compliance will fall to the manufacturer too. This is important to note as pushing the boundaries of the manufacturer-EAR relationship may lead to some serious consequences.

The largest risk a manufacturer runs in pushing the terms of agreement with an EAR in regards responsibility and liability is the potential termination of the agreement. As dictated in 2001/95/EC, without an established representative inside the European community, a manufacturer based outside of Europe may not place products on the European market. As a result, products found to be non-compliant in this way may face market withdrawal or even an outright ban.

One knock-on effect of this is that agreements ended in this way can often make it harder for a manufacturer to establish a relationship with a new EAR. This can leave manufacturers locked out of the European market as a result or open to any other combination of avoidable consequences. It is for that reason that it is advisable for all manufacturers to be fully aware of all responsibilities required of them in such situations, and to employ the services of a knowledgeable EAR who can keep them informed of the correct processes and procedures.

For more information on product compliance issues under Directive 2001/95/EC (or any other EU Directive or Regulation your product may be subject to), to get a free quote on Obelis’ Authorized Representative or CE Marking services, or from advice from our team of EU regulatory experts, contact us today.

Heavy Metals in Cosmetics http://obelis.net/heavy-metals-in-cosmetics/ Wed, 21 Feb 2018 08:15:21 +0000 http://obelis.net/?p=3188

The use of heavy metals in cosmetic products has always been a complicated issue around the world and remains so to this day. From a technical standpoint, the use of any kind of heavy metal in a cosmetic product is strictly banned inside the European Union under EU Regulation 1223/2009. The regulation, designed to harmonize standards throughout the EU and to ensure greater levels of consumer safety, set out a number of guidelines for manufacturers to adhere to, including forbidding the use of heavy metals (like arsenic, lead, tin, chlorine, cobalt, mercury, and zinc) and introducing mandatory safety reporting to ensure products are in compliance. For manufacturers of cosmetic products, this can sound like bad news, however there are things that can be done to bring products into compliance and for many products there is a little leeway given.

Like many of the other New Approach Directives, the objective of Regulation 1223/2009 was to ensure greater safety on the European Market for both manufacturers and consumers. For this reason, the use of heavy metals (or any compound made from a heavy metal) in cosmetic products has been strictly forbidden on account of the risk such ingredients may pose to consumer health and safety. Before entering the European Market, under 1223/2009, each manufacturer of cosmetic products must provide a Cosmetic Product Safety Report (CPSR) supplied by an assessor who is fit to declare the product safe for market introduction, effectively creating a barrier for products with heavy metal ingredients from entering Europe. Steps like this have led to a widescale decrease in the use of dangerous heavy metals Europe-wide.

While this may seem like a strict, cover-all rule, there are some instances in which products containing trace amounts of a heavy metal can enter the EU marketplace. Though no limit for the maximum amount of a heavy metal allowed inside a cosmetic product exists in Europe (unlike in Canada or the USA for example), unintended trace amounts may be included in a cosmetic product under the condition that the amount included presents no danger to human health and that the trace amount is so small that it could not be avoided under any reasonable Good Manufacturing Practices (GMP) as laid out by accepted EU guidelines. This creates allowances for products which may be exposed to banned metals throughout their manufacturing processes, while in storage or being transported, or as a result of an impurity from any of its other accepted and legal ingredients.

Awareness on part of the manufacturer of any traces or inclusions of heavy metals in their cosmetic products is highly encouraged as there can be many negative outcomes for a product found not in keeping with EU regulations. European Competent Authorities perform regular market surveillance checks often resulting in non-compliant products being removed or banned from the market.

For more information on heavy metals in cosmetics, to talk about the Compliance path for your cosmetic product, or to contact our team of European regulatory experts, get in touch today!

Aesthetic Products Under New Medical Device Regulation http://obelis.net/aesthetic-products-falling-under-new-medical-device-regulation/ Wed, 14 Feb 2018 08:06:58 +0000 http://obelis.net/?p=3173

Changes brought on by the recently adopted Medical Device Regulation, Regulation 2017/745, have been a cause of concern for some manufacturers of products used within the medical industry. Introduced on 5th April 2017, the new medical device regulation widened the scope of what can be classed as a ‘medical device’, leaving many manufacturers questioning what implications this has for their products or devices and how this will affect the compliance process.

The regulation, in an effort to reshape and improve essential health and safety practices and guidelines, has widened the scope of what we understand to be a medical device to include so-called ‘aesthetic products/devices’. Aesthetic products or devices are defined as any product or device “without an intended medical purpose” but that is still used in the same manner as or has similar characteristics/risks to use as a medical device already under the scope of the previous regulation. The main consequences this will have for manufactures of aesthetic products is that any product affected by the new regulation will need to be brought into full compliance with MDR 2017/745, including adding (unless already installed) the required standard of notification and post-market surveillance practices.

The changes introduced were designed to ensure a higher level of safety for the consumer and a higher level of transparency and harmonization with EU practices for manufacturers. The regulation will ensure that devices, of all kinds, will live up to their claims and are suitable for their intended purpose under regular conditions of use without compromising the safety of the user. Some examples of devices that will be affected by the regulation include:

  • Contact lenses
  • Products intended to be introduced into the human body through surgically invasive means
  • Facial dermal fillers
  • Equipment for liposuction
  • Lasers for skin resurfacing, tattoo or hair removal
  • Equipment for electromagnetic brain stimulation
  • Products or cleaning or sterilizing devices used in a medical capacity


Other additions in 2017/745 which will affect manufacturers include the requirement for products to be submitted to the EUDAMED database, a Europe-wide bank of information on all medical devices on the EU Market, and the introduction of a Unique Device Identification (UDI) system dictating that UDIs must be attached to the packaging of each product or device. It also calls for manufacturers to set up satisfactory incident reporting, risk management, and customer complaint processes to ensure best practices for post-market surveillance are upheld.

Manufacturers will have until 2020 to bring all their products and devices that fall under the scope of 2017/745 into compliance with the regulation, which leaves plenty of time to upgrade compliance processes, compile the necessary Clinical Evaluation Reports and begin the notification process.

To find out more about what implications 2017/745 may have for your medical device or aesthetic product, to talk to our team of European regulatory and compliance experts, or to get a quote about any of our services, contact us today!

Implementing a GMP for Cosmetics http://obelis.net/implementing-a-gmp-for-cosmetics/ Wed, 07 Feb 2018 09:24:13 +0000 http://obelis.net/?p=3163

A clear and transparent set of Good Manufacturing Practices is a legal requirement under European regulation EC 1223/2009 for any manufacturer of cosmetic products looking to release their products onto the European Market. Installed in order to ensure harmonization with consumer health and safety requirements inside the European Union, Regulation 1223/2009, in connection with ISO 22716:2007, lays out a number of guidelines all manufactures must adhere to. Factors falling into the Good Manufacturing Practices (GMP) process can include things like product control, shipment, and storage, as well as proper waste management and recall procedures – many of which are included in a cosmetic product’s Product Information File (PIF).

In many cases this can often cause undue stress for manufacturers who find themselves asking when they should begin the compliance process and how they can prove their compliance once the process is completed, sometimes questioning through lack of regulatory knowledge whether, if at all, their product is in line with ISO guidelines. It may relieve some to hear that while compliance with and proof of GMP is mandatory, there are several ways that evidence can be provided, and while compliance with ISO guidelines may be the most straightforward way, there are other options.

As stated above, evidence of Good Manufacturing processes can be provided in a number of ways including self-declaration as a manufacturer, or by having a third-party issue a certificate following an on-site audit. A number of the following factors must be taken into consideration in the proof of GMP:

  • Manufacturer’s staff
  • Premises
  • Equipment
  • Raw Materials
  • Manufacturing Process
  • Waste Management
  • Change Management
  • Complains and Recalls
  • Auditing and Quality Control
  • Documentation
  • Storage


This is only a brief outline of some of the factors covered under GMP, others include guidelines for subcontracting, treatment of product deviations, control of the finished product, and more. As is the case with many European cosmetic regulations, adherence and proof of GMP within Europe is presumed, and the onus to be compliant is entirely on the manufacturer.

For more information on how to implement best GMP, to get a quote on our Responsible Person or advisory Services, or to get in touch with our team of European legislative experts, contact us today!

Game Plan for Upgrading Compliance under Medical Device Regulation 2017/745 http://obelis.net/game-plan-for-upgrading-compliance-under-medical-device-regulation-2017745/ Wed, 31 Jan 2018 09:37:24 +0000 http://obelis.net/?p=3150

Since the introduction of EU Medical Device Regulation 2017/745, manufacturers have been rushing to prepare for it taking full effect on 25th May 2020. The best advice is to start getting ready for the transition now to ensure a smooth process with no negative effects. The first step in getting ready for MDR 2017/745 is understanding what it is and what requirements it has for manufacturers of medical devices. With that in mind, we put some information together to help clear the process up!

The first thing many manufacturers will need to understand is that MDR 2017/745, amending Directive 93/42/EEC, widens the scope of what was once understood to be a ‘medical device’ to include “products without an intended medical purpose” (or aesthetic products). The implication of this is that now manufacturers specializing in products like contact lenses, facial dermal fillers, liposuction equipment, lasers for skin resurfacing or tattoo/hair removal, electromagnetic brain stimulation equipment, etc., will now have to comply with the terms of the new regulation. Such devices have been included due to their being considered as having some of the same characteristics or risks to use as medical devices already under the scope of the previous MDR. All manufactures concerned will also need to inform themselves on the new notification and post-market surveillance requirements (see below).

An advisable initial step for any manufacturer starting the compliance process is to review their full portfolio of products, identify any devices that may fall under the scope of MDR 2017/745, and finally conduct a strict assessment of their current levels of compliance.

After assessing which devices need upgraded compliance processes or information, the next step is to compile a Clinical Evaluation Report (CER) to ensure/communicate a product’s compliance with 2017/745. Some of the following other items/information, and their status in relation to compliance, may be required too by a Notified Body:

  • Device classification information
  • Labelling and packaging
  • Post-market surveillance procedures
  • Risk management processes
  • Technical File
  • Lifecycle plan for product
  • Identification of applicable standards


Preparing for MDR 2017/745 also involves understanding and taking steps to bring practices into line with new post-market surveillance requirements introduced by the regulation. The aim of the regulation is to make products, and therefore all safety information, more transparent within the European community; as such, 2017/745 has introduced both the EUDAMED database and a requirement for a Unique Device Identification (UDI) to be affixed to each affected medical device’s packaging. The most immediate step to be taken here is the call for an incident reporting, risk management and reporting process for each device, as well as encouraging manufacturers to notify healthcare professionals of potential health risks associated with the product.

Though the regulation, as stated above, leaves some time for manufacturers to bring all products into compliance – including the provision that any product issued with a CE Certificate to date will have that certificate remain valid until the indicated expiry date – it is highly advisable that processes are put in place as soon as possible to ensure a smooth transition.

For more information on Medical Device Regulation 2017/745 and how it may affect your product, for general CE Marking enquiries, or for some advice from our team of European regulatory experts, contact us today!