The General Data Protection Regulation (GDPR) was adopted on the 14th of April 2016 and has entered into force on the 25th of May 2018. The Regulation replaces the Data Protection Directive and aims at harmonizing the data protection laws across the European Union and protecting and empowering EU citizens with regards to their data protection rights.
General Data Protection Regulation – scope and main changes
Proposal of “Goods Package” to improve compliance of products on the EU Market
Products on the Single Market
The Single Market is one of EU’s biggest successes, enabling goods, services, capital and people to circulate freely, providing more choices and opportunities for both entrepreneurs and consumers. As such it is essential that the products circulating on the market are compliant with the related legislation applicable to them.
Phthalates found in toys on the EU market
A recent study published by the ECHA’s Enforcement Forum Inspectors has found that a relatively high number of products on the European market (18% of the products of the sample) – contain chemicals restricted in the European Union.
The PPE Regulation countdown is about to start
On 21st April 2018 the (EU) 2016/425 PPE Regulation of the European Parliament and of the Council on the Harmonization of the laws of the Member States regarding Personal protective equipment will become fully applicable. Manufacturers whose products are compliant with the current legislation (PPE Directive 89/686/EEC) may benefit from the one year transition period until 21st April 2019 to comply with the new requirements.
Biocide or Medical Device – the borderline cases
Determining the appropriate regulatory status of products that contain one or more biocidal active substances can potentially lead to confusion. It is especially relevant when it is not clear whether the product is covered by the Medical Devices (MDD) or Biocide directive.
The new CE marking process for the Low Voltage Equipment
On the 20th April 2016, the LVD 2014/35/EU (Low Voltage Directive) of the European Parliament and of the Council relating entered into force. This directive applies to electrical equipment designed for use within certain voltage limits introduced to the EU market. Read more
New limits for BPA in toys
Additional requirements in the EMC Directive 2014/30/EU
On 18th April 2014, the new EMC 2014/30/EU (Electromagnetic Compatibility Directive) of the European Parliament and the Council came into force. The new EMC Directive 2014/30/EU repealed the Directive 2004/108/EC, keeping the same scope of protection against the electromagnetic disturbance in every country within the European Economic Area. Read more
Last call to be compliant with the new Radio Equipment Directive 2014/53/EU
On 16th April 2016 the RED 2014/53/EU (Radio Equipment Directive) of the European Parliament and of the Council on the Harmonization of the laws of the Member States regarding radio equipment entered into force. Manufacturers whose products are compliant with the current legislation (R&TTED) will have until 13th June 2017 to comply with the new requirements. Read more
Updated version of the EU “Blue Guide” published!
On the 5th April 2016, the European Commission published an updated version of “The Blue Guide on the Implementation of EU Product Rules”. The document, commonly referred to as the “Blue Guide”, sets out guidelines on introducing products to the EU market. It serves as a reference point for the implementation of all the CE marking directives and regulations. The new version of Blue Guide replaces the 2000 edition.
Key topics & changes
The Blue Guide explains how the EU regulates the free movement of goods. Some of the key points covered by the guide include:
- actors in the product supply chain and their legal obligations
- product requirements
- conformity assessment
- market surveillance
The 2016 version includes both revised and brand new chapters. The new ones concern, among other things, the obligations of manufacturers and other actors as well as the application of legislation for online sales. The 2016 edition also sets out new guidance on the update and translation of the Declaration of Conformity and on the format of instructions for use.
One of the key actors in the supply chain, as listed in the Blue Guide, is the Authorized Representative. The Authorized Representative is a legal representative required for all non-European manufacturers placing goods on the EU market. Its main role consists of providing a registered address in the EU, serving as a vigilance contact point, completing EU notification, national registration and representing the manufacturer towards the competent authorities.
Blue Guide available on Obelis website
The entire text of the 2016 edition of Blue Guide is now available on the Obelis website in the CE Marking Legislation section. If you wish to know more about the guide and the legal requirements for introducing goods into the European market, do not hesitate to contact us.
European Commission Publishes New Guidelines on PPE Directive
On 19 October 2015, the European Commission published new Guidelines on the application of Personal Protective Equipment Directive 89/686/EEC (PPE Directive). Read more
Common Approach on the Medical Devices Legislative Package
On October 5, 2015, the Ministers of the EU countries agreed, after almost three years of discussions, on a general approach on the medical devices legislative package. This agreement is a major step towards ratification of new regulations on medical devices and in vitro medical devices that would ensure a higher level of health and safety protection for EU citizens as end users of these devices.
New Harmonized Standards on R&TTE
Final Opinion on the Safety of Medical Devices containing DEHP (phthalate)
After months of public consultation, The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has now published the final Opinion on the safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates and other groups that are possibly at risk. Read more
IMDRF proposes QMS Principles for Software as a Medical Device
In April 2015, the International Medical Device Regulators Forum (IMDRF) released a new guidance document on the application of Quality Management Systems (QMS) for software as a Medical Device (SaMD). Public consultation was open until 2015 June and final document is supposed to be published in October 2015. Read more
New Low Voltage Directive 2014/35/EU
The Low Voltage Directive (LVD) 2006/95/EC is one of the oldest Single Market Directives. It covers the conformity assessment procedure applied to equipment before placing on the Market and Essential Health and Safety Requirements which such equipment must meet either directly or by means of harmonised standards. Read more
New Electromagnetic Compatibility Directive 2014/30/EU
All electric devices or installations influence each other when interconnected or close to each other. The purpose of electromagnetic compatibility (EMC) is to keep all those side effects under reasonable control. EMC designates all the existing and future techniques and technologies for reducing disturbance and enhancing immunity. Read more
New Pressure Equipment Directive
New version of the Blue Guide 2014. What is new?
In April 2014, the European Commission finally published the revised Blue Guide on the implementation of EU products rules (The “Blue Guide”). This updated version of the Blue Guide reflects the modernization and harmonization of the EU legislative framework for marketing of products.
The Concept and Objectives of the revision
The New Blue Guide updates the previous edition of the Blue Guide (Guide to the implementation of the directives based on the New Approach and the Global Approach), published in 2000. Since then, as it is stated in the new Blue Guide, it has become one of the main reference documents explaining how to implement the legislation based on the New Approach, now covered by the so-called New Legislative Framework (NLF). Read more
New package of measures for marketing of products
EU Commission revises 700 Old Approach directives and 27 New approach Directives
The Package of measures known as the “New legislative framework” was published in the Official Journal on 13 August 2008. The measures are designed to help the internal market for goods work better and to strengthen and modernize the conditions for placing a wide range of industrial products on the EU market.
The target of the New Legislative Framework is:
- Improve market surveillance rules to better protect consumers and professionals from unsafe products
- Boost the quality of the conformity assessment of products
- Clarify the meaning of CE marking
- Define roles of economic operators
OEM Manufacturers – Obtain your own CE Marking!
Obtaining the CE Marking provides a great strategic advantage for any manufacturer! – This is true whether your business is one of an Original Equipment Manufacturers (OEM) or an Original Brand Labeler (OBL).
If you are an OEM manufacturer – Obtain your own CE Marking today!
What is the difference between OEM & OBL?
Original Equipment Manufacturer (OEM) is defined as a company which supplies equipment to other companies to resell or incorporate that product under their own brand name – meaning, OEM Manufacturer will never place the product on the market under their name or trade names.
Original Brand Labeler (OBL) is defined as a company which obtains equipment manufactured by other companies to resell or incorporate that product under its own brand name – meaning, OBL Manufacturer will be the one placing the product on the market under their name or trade names.
As such, the OBL will be the one required to complete the CE Marking process for the products he intends to place on the market under his name. As OBL, he will rely almost entirely on the OEM support towards information on the product and on the manufacturing process. This information is mandatory under the CE Marking process.
What are the benefits of the CE Marking Strategy for OEM Manufacturers?
BENEFIT # 1: A powerful regulatory tool.
By obtaining the CE Marking, the OEM manufacturer has proof that:
- His product is safe
- His product meets the essential requirements of the EC Directives & Regulations
- His product technical documentation are complying with the requirements
- His product has achieved compliance with the CE marking process.
Additionally, for products requiring the intervention of a Notified Body, the timeframe for the introduction of the products can be significantly shortened as the product & the manufacturing process by the OEM will not need to be reassessed for a product which was only rebranded by the OBL.
BENEFIT # 2: A powerful marketing tool.
It is clear from the above that the OBL (the customer of the OEM) will be much more eager to conclude a purchase of a product already regulated rather than a product which is not yet regulated – as such, an OEM should publish & promote his CE Marking (marketing activities).
The European Authorized Representative support to OEM Manufacturers
European legislation has long defined the mandatory requirement for any manufacturer not established within the European Union to designate a European Authorized Representative. The support a professional Authorized Representative will provide will focus on:
- Providing a Registered Address in the EU
- Keeping available Technical Documentation for inspection by EU Authorities
- Completing Notification to the EU Authorities
- Completing (any) Registration to National Databases
- Taking care of (any) incident reporting
- Representing towards the EU Commission, EU Authorities, Notified Bodies and users
- Safeguarding the compliance with News and Regulatory Updates
- Supporting on a continuous basis on the CE Marking strategy
- Developing an international compliance platform towards global markets
OEM manufacturers, who aim to expand their sales in the European Market and other global markets, should consider the European compliance process as an important investment towards their success. They should make use of a professional European Authorized Representative to guide them through the regulatory maze towards exploiting the benefits of the CE Marking into their overall company strategies.
If you would like to know more on the CE Marking strategy for OEM Manufacturer, please do not hesitate to contact us.
NEW EC Directive on Radio & Telecommunications
Directive 1999/5/EC on radio and telecommunications terminal equipment, is intended to be repealed by Directive 2014/53/EU. The new Directive 2014/53/EU was published on the official journal of the European Union on April 16th 2014 and will enter into force on June 13th 2016. The new Directive will be pivotal towards achieving a unified internal market in the area of radio and telecommunications terminal equipment.
According to the EU Commission Press Release (http://europa.eu/rapid/press-release_IP-14-261_en.htm), Changes in the new directive include:
- A clearer requirement that radio receivers achieve a minimum level of performance so as to contribute to an efficient use of radio spectrum;
- Clear obligations for manufacturers, importers, distributors & authorized representatives;
- Improved instruments for market surveillance;
- Unnecessary administrative obligations will be removed (such as the pre-market notification of radio equipment using non-harmonized frequency bands);
- Ensure compliance of software in combination with radio equipments;
- The possibility to require mobile phones and other portable devices to be compatible with a common charger (!)
Impact on the Authorized Representative
Directive 2014/53/EU provides the following definition (Article 2.13) for the authorized representative – ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;
According to the Directive, the mandate with the authorized representative must allow him to do at least the following (Article 11):
- Keep the EU declaration of conformity and the technical documentation at the disposal of national market surveillance authorities for 10 years after the radio equipment has been placed on the EU market;
- Further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the compliance of radio equipment;
- Cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by radio equipment;
The Directive intended to repeal the current 1999/5/EC Directive will reduce the interference usage between radio equipments and will increase the growing numbers of users. Manufacturers, importers, distributors and authorized representatives will have to respect a set of clear obligations so as to ensure compliance. Finally, the alignment of radio equipment rules with other product legislations will lower compliance costs.
If you would like to know more on the new R&TTE Directive, please contact us.
More Supervision on Notified Bodies by NEW 920/2013 Regulation
On September 24th 2013, The European Commission has published the Implementing Regulation 920/2013 on the designation and the supervision of Notified Bodies that sets more stringent requirements for the designation and surveillance of Notified Bodies (NB).
The new measures were adopted as a part of the European Commission Joint Plan for Immediate Action, whose aim is to restore confidence in the Medical Devices sector following the Poly Implant Prothèse breast implant scandal.
What’s new in the regulation:
The Regulation consists of 10 Articles and 2 annexes.
The main novelties of this legislation are focused on the:
- Introduction of a joint assessment procedure for the designation of Notified Bodies (EU bodies accredited to certify theCE marking), involving experts from the European Commission and from the designating authorities of other Member States. Moreover, the designation of NB becomes limited in time and needs to be regularly renewed.
- Clarification of the essential knowledge and experience requirements for the staff of the NB.
- Obligation to conduct regular monitoring and surveillance of NB in order to ensure that they are constantly compliant with the relevant Organizational and General Requirements identified in Annex II of the Implementing Regulation.
- Possibility to perform unannounced on-site audits of NB.
- Exchange of experience between designating authorities on relevant questions concerning the interpretation of provisions of Directive 90/385/EEC and Directive 93/42/EEC.
- Enhanced cooperation between the European Commission and National Competent Authorities (the Assessment Reports shall be made available, upon request, to all other Member States).
Impact on the Authorized Representative
The Implementing Regulation 920/2013 reaffirms the distinction of roles between Notified Bodies and Authorized Representatives:
Article 1.3 of Annex I (on the Interpretation of criteria set out in Annex 8 to Directive 90/385/EEC and in Annex XI to Directive 93/42/EEC) explicitly states that “Conformity assessment body, its top management and the personnel responsible for carrying out the conformity assessment tasks shall not offer or provide or have offered or provided, during the last three years, consultancy services to the manufacturer, his authorized representative, a supplier or a commercial competitor”.
The new Regulation, therefore acknowledges the role of the European Authorized Representative as provider of consultancy services and regulatory updates to MD manufacturers.
Expectations for the future implementation
The implementation of the provisions contained in Regulation 920/2013 will ensure a better supervision of Notified Bodies and of their activities and an improved flow of information between the competent authorities and Notified Bodies both at national and EU level.
If you would like to know more on the new Regulation on the Designation and Supervision of Notified Bodies, please contact us
Code of Conduct for Notified Bodies?
TEAM-NB is the European Association of Notified Bodies for Medical devices. It is a non-profit organization which its members are Notified Bodies (EU bodies accredited to certify for CE marking). It has recently published the version 3.0 of the code of conduct for Notified Bodies.
How and whether to Audit Authorized Representatives?
TEAM-NB is the European Association of Notified Bodies for Medical devices. It is a non-profit organization which its members are Notified Bodies (EU bodies accredited to certify for CE Marking). It has published on November 7th 2012, a position paper titled “How and whether to audit Authorized Representatives”?
How to select a Notified Body?
Notified Bodies are organizations accredited by national EU competent authorities with the aim to support the manufacturer in carrying out conformity assessment procedures and issuing conformity certificates, supporting the manufacturer to affix the CE marking to his medical devices. Such conformity procedures and certificates are required under the “New Approach” Directives for medical devices – MDD 93/42/EEC, AIMDD 90/385/EEC and IVDD 98/79/EC.
New WEEE Directive 2012/19/EU (Waste of Electric & Electronic Equipments) is published
What is the objective?
The utmost aims of the WEEE Directive are to reduce the amount of waste electrical and electronic equipment that piles up in landfills and to enhance a more efficient environmental protection. The Official Journal of the European Parliament has published the NEW WEEE Directive 2012/19/EU on 24 July 2012; nearly ten years after the first WEEE Directive 2002/96/EC & 2003/108/EC
EU Market, Timeline & Harmonization
EU Market Timeline:
1. The European Community (1957)
2. Schengen Visa area (1985)
3. Unified European Market (1992)
4. “New Approach” (1985,1989,1993 & 2010)
5. The Euro born (2002)