The new machinery regulation is finally approved
After 18 months of negotiations a new machinery regulation is finally approved. The expectation is that the Regulation will enter into force this summer. In this article Certification Company reminds about the main changes that manufacturers and other economic operators should take into account.
Guidance for the EU Authorised Representative and PRRC (MDR 2017/745)
EU Authorised Representative and PRRC of medical devices have now the guidance about the duties and the responsibilities based on MDR 2017/745. Read more about Article 11 and Article 15 of the MDR 2017/745.
MDR transition period is changed
Begin January, the EU Commission formalized the proposal to update Art. 120, Art. 122 and Art. 123 of the MDR 2017/745. This has been done with intention of giving Notified Bodies (NoBo’s) more time to certify manufacturers and so that (legacy device) manufacturers intending to transition to the MDR, will benefit from the extended transition...Read More →
Difference between a CE certificate and an EU Declaration of Conformity
EU Declaration of Conformity or CE Certificate is needed to affix the CE mark? Read summary of differences between CE Certificate and EU Declarartion of Conformity.
Updated UK Regulation for medical devices
Read this update about a new UK medical device Regulation and about different rules for Northern Ireland.
European Commission Published Draft of New Construction Products Regulation
Thee European Commission (EC) published the draft for a new Construction Products Regulation. Read why implement a New Construction Products Regulation and what will change.
EAC Certification: Option For An On-site Remote Audit Extended
Are you a manufacturer and do you wish to market your products in Russia and the EAEU? Or are you currently already doing so? Then read further because Certification Company explains how such an 'external on-site audit' works in practice.
EU battery regulation proposal: what does this mean for toys?
As part of the European Green Deal, the European Commission has proposed a new EU Batteries Regulation. You can read about the consequences of this proposal for battery-powered toys in this article.
CE regulations for switchgear and controlgear cabinets
Are you a manufacturer of switchgear and controlgear cabinets or of machinery in which these kinds of cabinets are installed? And do you have questions about CE regulations? Then read further.
Internet of Things (IoT): What do you need to bear in mind when it comes to certification?
Under the framework of the EU Cyber Security Strategy, Europe is working hard on legislation, directives and standards in the field of IoT and cyber security. Are you a manufacturer of IoT equipment? Then it is important that you keep up to date with the laws and regulations.
EUDAMED - European Database on Medical Devices
Are you a manufacturer, authorised representative or importer of a medical device? If so, you will soon (most likely in May 2022) need to register information about yourself, your company and the medical device in EUDAMED.
MDR & Implementing Regulation (EU) 2021/2226
Implementing Regulation (EU) 2021/2226 makes possible for manufacturers of medical devices to provide electronic instructions for use only. Read more about the conditions of EU 2021/2226.
Cybersecurity and the Radio Equipment Directive
The Delegated Act to the Radio Equipment Directive (RED) has laid down new legal requirements for cybersecurity of wireless devices.
Export to Russia and the EAC marking
All information about product certification for export to Russia & EAEU member states. Certification Company assists you from A to Z.
Breaking news: European Commission published second batch of harmonised standards under MDR
On January 4, the European Commission recognised nine harmonised standards for medical devices that manufacturers can reference in order to satisfy conformity requirements under the Medical Devices Regulation (MDR 2017/745).
The major changes of the Machinery Regulations
On the 21st of April the proposal text for the new Regulation on Machinery was presented by the European Commission. The main legal changes of the proposal are summarized in this article.
Introduction to the New Machinery Regulation
The Machinery Directive is one of the most vital European product legislative Directives. The current Machinery Directive dates back to 2006. After 15 years, it became high time for a modernization, from both a technological as well as a legal point of view.
What is a EU Declaration of Conformity?
A CE Declaration of Conformity (also called a CE Certificate) is the document certifying that the product complies with applicable law.
Northern Ireland Protocol and CE marking
Northern Ireland is considered to be a special case, when it comes to conformity legislation, since the UKCA marking (valid in Great Britain (GB)) is not recognized in Northern Ireland (NI). As of January 1, 2021, the NI product certification is covered by the Northern Ireland Protocol.
Overview of the Pressure Equipment Directive 2014/68/EU
Are you a manufacturer and is your pressure equipment in conformity with the essential requirements of this directive? Then you are permitted to affix a CE marking to your pressure equipment. In this article you will learn more about obtaining a CE marking and which steps to follow.
The Digital Age and the EC proposal for Artificial Intelligence (AI) Regulation
On 21 April 2021 the European Commission proposed safety rules and actions, focused on Artificial Intelligence, with the purpose of harmonising the AI systems safety rules.
MDR 2017/745 Implementation: Are you prepared?
MDR 2017/745 is in force. Get all the updates and requirements introduced by the new Regulation.
EU Product Safety Award
The EU Product Safety Award celebrates businesses – large and small – that are going the extra mile to protect their customers and uphold the highest standards.
Decree № 478 and EAC Standards
The Decree 478 has come into force only in Russia. This Decree sets up rules for registering DoC, barring a few exceptions.
UKCA: the new marking within the UK market
To gain an understanding of the UKCA conformity procedures, it is important to receive an in-depth overview of the basic amendments. Let us briefly outline the post-Brexit effects on the UK market landscape, specifically with regard to product certification for placing products on the GB (Great Britain) market.
CE marking for medical software & Apps
Software and apps that are essential to the proper functioning of a medical device must be CE marked.
What is a toy according to the Toy Safety Directive 2009/48/EC?
Many products can be used in play by children, but that does not mean that all objects fall under the definition of a toy. The Toys Directive describes what a toy is on the basis of a number of criteria.
The Toy Safety Directive 2009/48/EC and CE marking
The Toy Safety Directive 2009/48/EC defines the essential safety requirements for toys to comply with before they can be placed on the EEA market. Read all important moments in simple words.
Medical Devices Regulation 2017/745
Due to COVID-19 the implementation date of Medical Devices Regulation 2017/745 has been postponed until 26 May 2021.
Overview Machinery Directive 2006/42/EC
Machinery Directive 2006/42/EC applies to almost every type of machinery, but the compliance procedure is different and depends on type.
Machinery Directive 2006/42/EG and CE marking
Explanation of the Machinery Directive 200/42 /EG and CE marking. All important details in simple words.
Product categories that require CE Marking
The question whether the product should bear the CE marking is always in the top-3 queries of economic operators. For a quick check, please have a look at the following product categories that require CE marking
What is a CE marking?
A CE marking is an important indication of the conformity of a product with the relevant European product legislation. However, a CE-marking on a product merely serves as an indication (not as proof) of its compliance.
New authorisation rules for RF devices
The FCC (The Federal Communications Commission, USA) has adopted new authorisation rules for radiofrequency devices, such as mobile phones or tv-receivers
Exemption from RoHS standards has expired for industrial measurement and control equipment
As of 22 July 2017 specific industrial measurement and control equipment must comply with the requirements of Directive 2011/65/EU regarding the restriction of the use of specific hazardous substances in electrical and electronic equipment (“the ROHS Directive”).
Brexit and Product Safety
What are the implications of Brexit for European Harmonised Law on product safety? written by Serge Koumachev and Susanna Nijsten for Health and Safety International
CE marking on industrial, commercial and residential garage doors
Manufacturers, importers and distributors of industrial, commercial and residential garage doors should take into account the required CE marking. Industrial, commercial and residential gates should comply with the harmonised standard EN 13241. Within the scope of the Construction Products Regulation (305/2011) this standard requires an obligatory CE marking. The EN 13241 harmonised standard specifies the...Read More →
Toys safety and certification: the US Toy standard F963-16
On 20th October 2016, the American Society for Testing and Materials (ASTM) published a revised US Toy Standard ASTM F963-16 regarding toys and juvenile products.
Future changes for Medical Devices
Several key points that are differ from current Directives for medical devices and active implantable devices.
New Lead Limits for Toys
In August 2016 European Commission published Draft Directive to adopt lead limits for toys under Toy Safety Directive 2009/48/EC.
New Radio Equipment Directive 2014/53/EU
Starting from 13 June 2016 all member states must apply the new Radio Equipment Directive (RED) 2014/53/EU. Check new requirements for affixing the CE marking.
New EMC Directive 2014/30/EU
After 2014 April 2016, the CE Marking conformity assessments processes should be afdapted to the new EMC Directive 2014/30/EU. Even though the main changes are quite limited, they should be known and taken into account.
New Low Voltage Directive Guidelines
New Low Voltage Directive Guidelines were published in the beginning of November. The Guidelines is a manual that explain the details of new LVD.
New Low Voltage Directive 2014/35/EU
The new European Low Voltage Directive (LVD) 2014/35/EU will come into force on the 21st of April 2016. Manufacturers, importers, and distributors should take this date into account when planning deals on electrical equipment on EEA and EU markets. Scope Low Voltage Directive 2014/35/EU As the previous Low Voltage Directive 2006/95/EC, the new LVD applies...Read More →
Five frequently asked questions about EN 1090
There are many questions about the EN 1090 standard. We answer the most frequently asked questions about this standard. Find out if your question is also listed.
The Importance of CE Marking
It is mandatory for manufacturers, importers and distributors of non-food products to obtain the CE marking if they wish to trade on EU/EAA markets. However, not all products are required to have the CE marking.
Eco-design for Non-directional Lamps and LED lamps
As of February 27, 2016 the Regulation (EU) 2015/1428 will formally come into force. The Regulation amends Regulation (EU) 244/2009 eco-design requirements for non-directional household lamps.
What is NOT a toy according to the Toy Safety Directive 2009/48/EC?
The Toy Directive 2009/48/EC does not cover all products that we can name "a toy". Annex I contains an exhaustive list of products that are not regarded as toys.