CE Marking Services and EU Regulatory Consultants http://obelis.net Obelis Group Mon, 15 Apr 2019 08:00:29 +0000 en-US hourly 1 https://wordpress.org/?v=4.9.10 Questions and Answers: UK’s Withdrawal from the EU with Regard to Industrial Products http://obelis.net/questions-and-answers-uks-withdrawal-from-the-eu-with-regard-to-industrial-products/ Mon, 15 Apr 2019 08:00:29 +0000 http://obelis.net/?p=5236 As a consequence of the withdrawal of the United Kingdom from the European Union, all Union primary and secondary law will cease to apply to the UK from 12 April 2019, 00:00h (CET). The UK will then become a ‘third country’.

Economic operators should be aware of the consequent changes: EU rules in the field of non-food and non-agricultural products will no longer apply to the UK and to provide guidelines, the European Commission services published on 22 January 2018 a Notice to stakeholders. Additional Questions and Answers were published to address specific scenarios when it comes to industrial products – after the UK leaves the EU.

Unless a withdrawal agreement is ratified, the following rules and definitions will apply[1].

 “PLACING ON THE MARKET”

The concept of placing on the market refers to each individual product, not to a type of products, whether it was manufactured as an individual unit or in series. It relates to the first making available on the Union (EU-27) market, i.e. the first supply of a good for distribution, consumption or use after the manufacturing stage. Placing on the market does not require physical delivery of the product but does require that the manufacturing stage has been completed.

  1. Criteria to establish whether a product was placed on the Union (EU-27) market before the withdrawal date.

Scenario 1Goods physically in the distribution chain or already in use in the EU-27 market on the withdrawal date (i.e. held in the EU-27 by a wholesaler or already supplied to hospitals).

These goods are considered as placed on the Union (EU-27) market before the withdrawal date and can therefore continue to be made available in the EU-27 market or remain in use with no need for re-certification, re-labelling or product modifications.

Scenario 2Goods manufactured either in the EU or in a third country, sold to an EU-27 customer before the withdrawal date after the manufacturing stage was completed but not yet physically delivered to the EU-27 customer on that date.

Same as Scenario 1. The date of placing on the Union (EU-27) market is the date of the transaction between the manufacturer and the EU-27 customer after the manufacturing stage was completed. Placing on the market does not require physical delivery of the product.

Scenario 3Goods imported into the UK from a third country or manufactured in the UK, subsequently sold to an EU-27 customer before the withdrawal date but physically delivered to the EU-27 customer as of that date.

Same as scenario 1 and 2. The date of placing on the Union (EU-27) market is the date of the transaction between the UK economic operator (manufacturer, importer or distributor) to the EU-27 customer.

Scenario 4 – Goods imported into the UK from a third country or manufactured in the UK before the withdrawal date, subsequently sold to an EU-27 customer as of the withdrawal date.

The goods are placed on the Union (EU-27) market after the withdrawal date as the date of their first making available to an EU-27 customer is on or after the withdrawal date. The goods are considered as imports from a third country and will have to fully comply with the provisions of Union law applicable at the time of their placing on the market. Goods will have to have been certified by an EU-27 Notified Body, if required. Where applicable, they will also have to indicate the details of the EU-27 importer and of an EU-27 ‘responsible person’.

RESPONSIBLE PERSONS

Responsible persons based in the UK will lose their status as from the withdrawal date. Therefore, manufacturers need to ensure that, as from the withdrawal date, their designated responsible persons are established in the EU-27.

Scenario 1. Goods placed on the Union (EU-27) market before the withdrawal date.

No need for relabelling with the contact details of the new EU-27 responsible persons but economic operators will need to inform the competent national authorities about the appointment of a new responsible person established in the EU-27.

Scenario 2. Goods placed on the EU-27 market as of the withdrawal date, whether coming from the UK or another third country.

These goods will have to fully comply with the provisions of Union law applicable at the time of their placing on the market. Therefore, labels shall indicate the details of a responsible person established in the EU-27.

IMPORTERS

The importer is the economic operator established in the Union who places a product from a third country on the Union market. As from the withdrawal date, a manufacturer or importer established in the United Kingdom will no longer be considered as an economic operator established in the Union.

Scenario 1. Products which were imported into the EU-28 via the UK and placed on the Union (EU-27) market before the withdrawal date.

These products will not need to be relabelled with the indication of the EU-27 importer. No change to the labels is required.

Scenario 2. Goods imported into the UK market before the withdrawal date and made available to the EU-27 market as of that date.

EU-27 economic operators which were previously mere distributors of those products will become importers when making those products available in the EU-27 market for the first time, with more stringent obligations as regards product compliance. These products will need to be relabelled with the indication of the EU-27 importer.

NOTIFIED BODIES

Notified Bodies must be established in a Member State and designated by a Member State notifying authority for performing the conformity assessment tasks set out in the relevant act of Union product legislation. Products covered by a Certificate issued by a UK Notified Body will need to obtain another certificate from a EU-27 Notified Body in preparation for Brexit.

If a UK Notified Body Certificate is transferred to a EU-27 Notified Body, do the EU Declaration of Conformity and the actual Notified Body Certificate need to be updated to document this change?

Yes, these documents shall be updated.

Does the Notified Body number on the product itself need to be changed also for products already on the market or manufactured before the transfer of the certificates occurred?

In such cases there will be no need to change the Notified Body number on the products if:

  • The abovementioned documentation has been updated;
  • The products are already on the EU-27 market;
  • The products have not been placed on the EU-27 market but were manufactured before the transfer of certificate has taken place.

Products manufactured after the transfer of certificate to a EU-27 Notified Body should instead mention the new NB number.

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.

Martina Quitadamo

April 15, 2019

[1] The text cited represents extracts from the European Commission Questions and Answers document.

[1]  Annex to the Notice to Stakeholders presents an indicative list of all the affected EU product legislation. ]]> K-REACH Pre-registration Started from 1st January 2019! http://obelis.net/k-reach-pre-registration-started-from-1st-january-2019/ Mon, 18 Mar 2019 09:00:49 +0000 http://obelis.net/?p=5155 The Act on the Registration and Evaluation of Chemicals (Korea REACH) has been amended on 28th February 2018 by the South Korean National Assembly. The amended K-REACH entered into force on 1st January 2019 and implies new obligations for manufacturers and importers of cosmetics products in South Korea.

The Korean legislation has a lot of similarities with EU REACH and aims, through the action of the South Korean Ministry of Environment, at protecting public health and the environment through the registration of chemical substances.

According to the amended K-REACH, existing substances imported or manufactured in South Korea in a volume of 1 ton or above per year between 2016 and 2018 must be subject to a Pre-notification. This Pre-notification will allow manufacturers and importers to benefit from a period of grace for the corresponding registration.

Furthermore, according to K-REACH, non-existing substances (i.e new substances) must be registered before being manufactured or imported in South Korea.

The timeframe to complete the Pre-registration opened on 1st January 2019 and will close on 1st July 2019.
After this date, the manufacture, import or export to Korea of substances in volumes equivalent or exceeding 1 ton which will not have been pre-registered will be prohibited. In case of infringement of this new obligation imposed by K-REACH, the manufacturer or importer might be sentenced to 5 years of imprisonment.

If you would like to have more information on the Pre-registration of substances in South Korea or on K-REACH, please do not hesitate to contact us! With 30 years of experience, Obelis remains at your disposal to help you with any regulatory matter.

Manon Prado

March 18, 2019

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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.

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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.

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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!

 

 

 

 

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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

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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.

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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!

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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

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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!

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