What is CE MD Certification?
CE certification of medical devices (according to European Community standards) is mandatory for all equipment used in therapeutic and diagnostic procedures within the European Union. The process is regulated by EU Directive 2017/745 and relevant industry regulations, including 90/385/EEC, 93/42/EEC, 98/79/EC, and 722/2012.
Why is CE Certification for Medical Devices Important?
Only CE marking medical devices may be sold within the European Union. It confirms their conformity to the common inter-state standards, including those related to safety, efficiency, and convenience. The CE marking of medical devices is also considered equivalent to the national standards of Switzerland, Turkey, Australia, and some other countries. Thanks to this, the corresponding product marking gives you access to new markets.
Which Products Require CE MD Marking?
The CE mark medical devices can be sold within the European Union. This applies to equipment intended for therapeutic and diagnostic procedures. Special regulations apply to the following products:
- In vitro laboratory diagnostic equipment (for tests);
- Active implants, e.g. pacemakers;
- Products derived from animal tissue.
What Products Can Be Sold Without the CE MD Mark?
CE certification is not required if the product does not meet the definition of a medical device specified in EU Directive 2017/745 (MDR). In that case, other industry regulations apply to it, e.g. those regulating radio frequency or electromagnetic radiation. Products can also be sold without a CE certificate if alternative standards have been developed for them. This is the case for medicines, food products, cosmetics, and chemicals.
How to Apply for CE MD Certification?
The first step is to determine the type of device by the risk/benefit ratio. The easiest procedure is the CE certification of medical devices of Class A (I), which implies low risk. You can certify such devices yourself without applying to the authorities. If a device meets the harmonized standards of the European Union, the manufacturer only needs to draw up the technical documentation and perform tests in an accredited laboratory.
To obtain CE marking for Class B (II) and C (III) medical devices, they must be tested in a controlled environment under the supervision of representatives of the notified body. This is also applicable to Class A devices that do not meet the harmonized EU standards.
How to Get CE MD Certification?
The process for CE certification of medical devices consists of six steps:
- Demonstration of conformity — the manufacturer declares the product’s conformity to each standard that applies to that type of goods.
- Identification of medical device classes in accordance with EU Directive 2017/745.
- Selection of a testing method that fully confirms the safety, effectiveness, and usability of the device.
- Compilation of technical documentation describing the appearance, functions, software, and interface of the device.
- Drawing up the EC MD declaration of conformity.
- Submission of an application for certification to the regulatory body, if required.
The list of necessary documents and the structure of the testing procedure depends on the type of medical device. Testing of devices is performed by an accredited laboratory. Among its staff should be specialists with medical education, who are allowed to use the equipment for its intended purpose. Such testing must cover the full range of device functions.The timeframe for issuing the certificate varies depending on the niche and the application of the device. The average time for a Class A device is 4 to 8 weeks. Clinical testing of Class B and C devices can take several months.
Manufacturer’s Responsibilities Related to CE MD Certification
To obtain CE marking of medical devices, the manufacturer must:
- Comply with EU Directive 2017/745 when developing the device;
- Conduct testing and clinical trials;
- Implement a quality control system in accordance with ISO 13485;
- Conduct a detailed risk analysis and specify the risk-benefit ratio in the documentation;
- Update documentation when changes to EU standards are made;
- Provide all requested information to local authorities and authorized bodies;
- Implement an after-sales service system;
- Assign a unique identification number to each device;
- Register in the EUDAMED database.
Responsibilities of the Distributor of Medical Devices
A company that sells equipment within the European Union must be an authorized representative of the manufacturer or developer. To distribute CE-marked medical devices, you must make sure it conforms to the following requirements:
Sold only after receiving documentary proof of compliance with EU Directive 2017/745;
Delivered to customers unchanged (as designed by the developer);
Products are withdrawn from sale and recalled from customers if they do not comply with current standards.
Quick CE MD Certification with 360Compliance
We provide a full range of CE certification services for medical devices. Our employees provide assistance with all the stages of this procedure from evaluating the legal environment and determining the class of equipment to the paperwork and cooperation with authorized bodies. We guarantee transparent prices, clear deadlines, and convenient technical support. Get your certificate quickly and with a minimum of effort by leaving an application on our website to learn more about our services!
Other Certifications
CE Certification
Why is CE Certification Important? CE certification confirms that the product entered the market legally, has all the permits, and does not pose any threat to human health or the safety and integrity of the environment. Thus, the CE mark signals both buyers and official regulators about the successful completion of all testing and certifying procedures. What Countries Require CE Compliance? The mandatory CE certification applies to products entering the market of all 30 countries of the European Economic Area (EEA). It also covers Switzerland and Turkey, which have signed a number of bilateral agreements with the EU, including the CE marking requirement. European Economic Area Countries Other Countries Austria Denmark Hungary Lithuania Portugal Switzerland Belgium Estonia Iceland Luxembourg Romania Turkey Bulgaria Finland Ireland Malta Slovakia Croatia France Italy Netherlands Slovenia Republic of Cyprus Germany Latvia Norway Spain Czech Republic Greece Liechtenstein Poland Sweden Which Products Need a CE Mark? To date, CE marking applies to products whose market access is regulated by 25 Directives and Regulations. These groups of goods are subject to special control and thorough testing since non-compliance with safety standards during their production or operation can cause harm to people or the environment. The list includes the following product groups: Construction products; Measuring equipment of different types; Medical devices; Pyrotechnics and explosives; Telecommunication and radio equipment; Gas appliances; Yachts, boats, and other watercraft; Pressure equipment; Kids toys; Water heaters and boilers; Personal protective equipment; Cableways and lifts; Noisy equipment; Electrical equipment, and others. Products That May Be Sold Without a CE Mark Although CE marking is required for a wide range of products, not all goods imported into the listed countries need to pass this type of certification. In particular, goods belonging to the following categories, which are covered by other Directives, are subject to a different type of certification: Chemical products Cosmetics Food products Pharmaceuticals How to Obtain CE Certification? Obtaining a CE mark is a standardized procedure consisting of several stages with documental confirmation of their passage. It starts with determining the list of Directives that apply to certain products, then comes the data collection, technical assessment, and passing all testing procedures. When the CE marking of products is completed, they can be launched to the market. What is CE Certification Process? Determining the Directives and Standards Applicable to Certified Products The Directives include general safety requirements for products placed on the market. The specific parameters and technical requirements are detailed in the harmonized standards. If CE marking is required for a product that does not fall under any of the Directives, a document stipulating general safety requirements applies to it. Directive Number Product Category 2006/95/EC Low Voltage 2009/105/EC, (ex.87/404/EEC) Simple Pressure Vessels 2009/125/EC Ecodesign for Energy-related Products 2000/14/EC Noise Emission for Outdoor Equipment 2009/48/EC 88/378/EEC, 93/68/EEC Toy Safety 89/106/EEC, 93/68/EEC Construction Products 2004/108/EC Electromagnetic Compatibility 2006/42/EC Machinery 89/686/EEC, 93/68/EEC, 93/95/EEC, 96/58/EC Personal Protective Equipment 2009/23/EC (ex.90/384/EEC) Non-automatic Weighing Instruments 2009/142/EC (ex. 90/396/EEC) Appliances Burning Gaseous Fuels 92/42/EEC, 93/68/EEC, 2004/8/EC, 2005/32/EC Hot-water Boilers (liquid or gaseous fuels) 93/15/EEC Explosives for Civil Uses 93/42/EEC, 98/79/EC, 2000/70/EC, 2001/104/EC, 2007/47/EC Medical Devices 90/385/EEC, 93/42/EEC, 93/68/EEC, 2007/47/EC Active Implantable Medical Devices 98/79/EC In Vitro Diagnostic Medical Devices 94/9/EC Equipment Explosive Atmospheres 94/25/EC, 2003/44/EC Recreational Craft 95/16/EC Lifts 97/23/EC Pressure Equipment 99/5/EC Radio Equipment and Telecommunications Terminal Equipment 2000/9/EC Cableway Installations to Carry Persons 2004/22/EC Measuring Instruments 2007/23/EC Pyrotechnic Articles Examining the CE Requirements Harmonized standards are being studied to check whether the proposed product complies with all safety criteria and whether it can qualify for the CE mark. ESO Reference and title of the harmonized standard (and reference document) Reference of superseded standard Date of applicability of the standard as a harmonized European standard Date of the end of the co-existence period Note 4 CEN EN 1:1998 Flued oil stoves with vaporizing burners 01/01/2008 01/01/2009 EN 1:1998/A1:2007 Note 3 01/01/2008 01/01/2009 CEN EN 40-4:2005 Lighting columns – Part 4: Requirements for reinforced and prestressed concrete lighting columns 01/10/2006 01/10/2007 EN 40-4:2005/AC:2006 01/01/2007 01/01/2008 Compiling the Necessary Supply Chain Data Collecting technical files may require a lot of additional information depending on the product being certified. These can be technical drawings, documentation on the materials used to manufacture the product, wiring diagrams, and other details. All of them must be collected to expedite the CE marking procedure. Determining the Need for Authorized Body to Be Involved in the Product Evaluation Process Notified bodies (NB) participate in the certification process if it is specified in the Directives. In such cases, they audit all documents to ensure that the manufacturer has complied with all requirements. If the Directive does not require the participation of NBs, manufacturers may carry out the conformity assessment themselves. Body type Name Country NB 0086 BSI Assurance UK Ltd United Kingdom NB 2797 BSI Group The Netherlands B.V. Netherlands NB 1912 DARE!! Services B.V. Netherlands NB 0344 DEKRA Certification B.V. Netherlands NB 0124 DEKRA Certification GmbH Germany NB 2460 DNV GL Presafe AS Norway NB 0051 IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITA S.P.A. Italy NB 0482 MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH Germany NB 0050 National Standards Authority of Ireland (NSAI) Ireland NB 0197 TÜV Rheinland LGA Products GmbH Germany NB 0123 TÜV SÜD Product Service GmbH Zertifizierstellen Germany Passing Test Procedures Product testing is conducted by certified laboratories that confirm the safety of the product and its compliance with the criteria for obtaining the CE certificate. The result of this stage is a special laboratory test protocol, on the basis of which a certificate is issued. Preparation and Issuance of the CE Documentation At this stage, appointed experts check all collected papers, compare them with Directives and standards, and make a decision regarding the CE marking. In case of successful completion of the certification procedure, the manufacturer receives the CE mark and all required documents and can proceed to product labeling before launching it on the market. The manufacturer also draws up technical documentation, which confirms that the product has been certified, supporting its compliance with all standards. Preparation of the EU Declaration of Conformity and Placing the CE marking To import certified products into the territory of the EEA, a Declaration of Conformity is required for both manufacturers and/or distributors. It is drawn up by the manufacturer and is provided to distributors who will be engaged in the supply of goods on the territory of the EEA. CE marking is applied to the data plate of the product or to its package if, for technical reasons, it is not possible to stamp it directly on the product. This is the final stage, after which the product may be launched to the EU and EEA markets. Responsibility of Manufacturers for CE Certification To successfully complete the standard procedure for obtaining the CE mark, manufacturers must find out which EU Directive regulates the access of products of their category to the market and check compliance with all regulations. After that, a conformity assessment is carried out, on the basis of which a technical file is prepared. Further, the EU authorized body examines the documents, and the manufacturer issues the EC Declaration of Conformity (DoC). When all documents are certified and the CE mark is received, the manufacturer can label with this mark their products and packaging. Responsibility of Distributors for Products with a CE Mark Distributors of goods in the EU market must ensure that the CE mark has not yet expired and that the certificate itself is not fake. They also check the placement of the stamp on the product or its packaging since marking is the responsibility of the manufacturer. What Does CE Mark Mean? CE marking of goods is a declaration of the safety of goods for consumers and the environment by the manufacturer. The safety criteria are determined on the basis of the EU Directives, which specify the standards that products must meet when offered to consumers in the EU and other EEA countries. Therefore, the presence of the CE mark means that: All potential risks connected with the operation of the product are checked and meet the standards adopted in the EU. All New Approach Directives of the EU have been taken into account and observed. The proposed product will not harm the environment or the people using it. CE Certification: Other Directives The admission of goods to the EU and EEA markets is regulated by more than 20 Directives. Each group of products is covered by a specific Directive with established standards, for example, Toy Directive, Medical Devices Directive, Lifts Directive, EMC Directive, and others. Become CE Certified with 360Compliance The CE marking procedure can be tedious and incomprehensible to non-professionals. However, the 360Compliance team will help you pass all stages of certification quickly, competently, and successfully. You will receive full project management with no hassle. You are also guaranteed technical support and a transparent pricing policy. To start the testing & certification process for obtaining a CE stamp, contact the 360Compliance team in any convenient way and get all the answers and instantly initiate the certification procedure. Frequently Asked Questions About CE Marking For How Long is a CE Certificate Valid? For each product group, a certain validity period is established, but in most cases, it is three years. After that, you need to go through the re-certification procedure. However, there are products for which the CE mark is valid for 10 years or more. What are the Penalties for the Absence of a CE Certificate? Punishment for selling goods without the certificates in countries where the CE marking is mandatory varies widely from administrative to criminal liability. The specific article of the law that will be applied depends on the damage that a given product can cause to people or the environment. How to Get a CE Certificate? To obtain the CE stamp, it is necessary to go through a risk assessment procedure for the products offered. For this, you need to study the standards of the specific Directive that regulates access to the market for this type of products, make up a technical file, and pass testing. When all permits are issued, CE marking can be applied to the offered products. How to Authenticate a CE Certificate? You can authenticate a CE mark using the official database. Also, it is possible to contact the official authority that issued the certificate and request details on this product. If it turns out that this product is not registered with official institutions, you are dealing with fake certification.
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CE EMC Certification
What is CE EMC Certification? EMC CE is equipment electromagnetic compatibility certification that is governed by European Community regulations. In the European Union, it is mandatory for all products that intentionally use electromagnetic radiation for communication or other purposes. The standards and rules for the procedure are set by Directive 2014/30/EU. Why is EMC CE Certification Important? The EMC CE certification procedure is mandatory for all electronics sold in 28 EU countries. With this document, you have access to this market, which is the third largest in the world in terms of sales after the USA and China. CE standards are equivalent to national standards in Australia, Switzerland, Turkey, and some countries in the Middle East and North Africa, making them more valuable for manufacturers. Which Products Need the CE EMC Mark? The EMC CE testing is applicable to all devices that intentionally emit electromagnetic waves. 360Compliance specialists most often work with the following types of equipment: Smartphones and cell phones; Laptops, tablets, and desktop computers; Radio frequency identifiers (RFID); Medical equipment; Household appliances; Security systems; Industrial equipment; TVs and monitors; Children’s toys; Engineering infrastructure, and so on. What Products Can Be Sold Without the CE EMC Mark? CE EMC certification is not mandatory for products that do not emit electromagnetic waves. It is also not required if the electromagnetic radiation is a side effect obtained unintentionally by operating other machinery, for example, a refrigerator compressor or an elevator motor that can be a source of electromagnetic radiation. However, they can be sold without EMC CE certification because such emissions are not part of their basic functions and are not intended by the manufacturer. How to Apply for CE EMC Certification? EU directives set out three ways of passing the mandatory EMC CE certification procedure. The simplified method is available to manufacturers who have confirmed that their products comply with the harmonized EU standards. They only need to collect the required package of documents and arrange testing in an independent laboratory If the harmonized standards are not fully or partially complied with, or no uniform regulations for the industry have been developed, the normal CE EMC rules apply. Tests are carried out under the supervision of an authorized body, which makes the final decision on granting the certificate. A list of such institutions is published in the Official Journal of the European Union (OJEU). Another method of certification is applied for large companies that operate in accordance with international technical regulations. If they have already had a quality system certification that incorporates the EMC CE provisions, they only need to provide the documentation to the authorized body. The decision will be made based on an examination of its contents. How to Get CE EMC Certification? The EMC CE certification process is as follows: 360Compliance specialists determine which directives apply to the product. The role of the company applying for certification is established. Preliminary tests are conducted to identify deficiencies at an early stage. The electromagnetic power and sensitivity to electromagnetic radiation are measured. Technical documentation is compiled; Declaration of Conformity is prepared; If necessary, the documents are submitted to the authorized body. The permissible level of electromagnetic radiation and sensitivity to the background level of EM radiation is specified in Directive 2014/30/EU. To obtain a certificate, the manufacturer must provide technical documentation describing the appearance, functions, interface, and software used by the device. If the product has already been tested for compliance with harmonized EU standards and has been approved for sale in at least one country, the conclusions are also attached to the application. The EMC CE certification procedure takes 4 to 6 weeks on average. If the product belongs to an industry that is regulated by other directives (e.g. CE RED), it is subject to additional tests, which increases the time required. Manufacturer's Responsibilities Related to EMC CE Certification The company that develops a product shall design it according to EMC CE norms and confirm compliance with the norms by independent laboratory tests. It is also required to: indicate the actual electromagnetic radiation level in the documentation; warn about the possible hazards associated with the use of the device; provide the user with operating instructions; indicate geographical restrictions on the use of the product, if any; keep a register of complaints; store certificates and declarations of conformity for at least 10 years; cooperate with local authorities and provide product samples to the authorities. Responsibilities of Distributors Under the EMC CE Program The company distributing a product in the European Union must prove the authority given to it by the manufacturer or the developer. Before the start of sales, it must ensure that the products meet the relevant standards. If employees are in doubt as to whether regulations are being complied with, they must cease sales and recall the products they have provided to customers. The distributor has no right to interfere with components that emit electromagnetic waves. Differences Between CE EMC and EMC Certification CE EMC certification is a mandatory procedure in 28 European Union countries. It is also applicable in Turkey, Switzerland, Australia, and some other countries. The name EMC without the “CE” prefix refers to national EMC regulations, including those in effect in individual EU countries, the USA, Brazil, Taiwan, the UK, and others. Quick and Easy EMC CE Certification with 360Compliance Our company takes a comprehensive approach and offers a full range of services, from preliminary product assessment and legislative analysis to issuing a certificate or submitting an application to a notified body. Contact us to get transparent pricing, clear timelines, and technical support at all stages of the procedure. To learn more about CE EMC certification, send a request or contact us by phone.
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CE RED Certification
What is RED CE Certification? RED is a radio equipment directive adopted by the European Union on June 13, 2016. Its purpose is to create a set of rules to regulate the market for such equipment. It ensures the standardization of devices, efficient use of radio frequencies, user safety, and protection against data theft and fraud. The RED directive also serves as the basis for additional standards that relate to the following aspects: Emergency services calling; Compatibility of different types of equipment; Privacy protection and corporate secrecy; Crime prevention; Ensuring confidential communications of intelligence services. What is the Importance of the Radio Equipment Directive? RED certification allows you to sell equipment in all 28 countries of the European Union. It is the third-largest electronics market by revenue after the United States and China. Moreover, many countries adopted the CE RED standard as their national regulation. Among them are Australia and the countries of the Middle East and North Africa (MENA). What Products Need the RED Mark? All radio frequency emitting sources sold in the EU are subject to RED testing. Unlike the previous R&TTE standard, the new directive does not set limits on the frequency range and supply voltage of the device. Most often, customers apply for certification of such equipment: Smartphones and cell phones; Radio frequency identifiers (RFID); Common band transmitters (CB); Stationary and mobile satellite systems; Wireless networking equipment; Stationary wireless telephones; Industrial, scientific, and medical standard (ISM) transmitters; Avionics; Navigation systems; Telemetry for remote control of equipment; Wireless headphones and microphones, etc. What Products Can Be Sold Without the RED Mark? The RED directive does not apply to amateur communication devices. Examples are Walkie-Talkies, which are pre-tuned to a specific waveform and which operate over a short distance. RED certification does not apply to equipment used by the army, police, and national security services. The list of exceptions also includes: Aircraft communications and navigation systems, for which a separate standard EC216/2008 has been adopted. Shipboard radio equipment for river and sea vessels that is certified according to EN 60945. How to Apply for RED Certification? As set forth in the appendices of the RED directive, there are three ways for a manufacturer to bring a product to the market: Certification for conformity to harmonized EU standards. For that, the manufacturer must prepare the technical documentation package, conduct tests, and draw up a Declaration of Conformity. All materials must be available to local authorities for at least 10 years from the time the product is released on the market. If the product does not meet at least part of the harmonized standards, or regulations for the industry do not exist, CE RED testing is carried out under the supervision of authorized bodies. Their list is published in the Official Journal of the European Union (OJEU). If the manufacturer has certified a quality system according to standards that include RED CE norms, it can notify the authorized body of that. In this case, a simplified inspection is carried out, during which the technical documentation is examined. How to Get RED Certification? RED testing is intended to confirm product compliance with EU regulations for effective and safe use of radio frequencies. Devices must not interfere with other equipment and must not occupy free bands unless required. To pass the RED certification, the manufacturer must provide the following information: Technical documentation, including a description of the appearance, functions, interface, and software of the device; A copy of the Declaration of Conformity; If possible, a copy of the Certificate of Conformity to EU standards; Instructions for use, including accessories and software. On average, the RED certification procedure takes 4 to 8 weeks. For complex products, which must conform to a large number of regulations, the time frame extends to 8 to 12 weeks. Manufacturer's Responsibility The responsibilities of a company seeking RED certification are not limited to the submission of technical documentation. It must certify that its product is approved for use in at least one European Union country. It is also required to apply the CE marking to the product or packaging. If this is not possible, it must publish information about geographical limitations for the use of equipment, maintain a register of complaints, and submit samples of products to authorized bodies, if necessary. If the product does not comply with the CE RED regulations, it must be withdrawn from sale and recalled. Distributor Responsibility An authorized company selling equipment on the EU market must ensure that the products meet all the requirements of the RED standard. It is forbidden to take any action that may alter the technical characteristics and properties of the product. If its representatives have any doubts about the CE RED compliance of equipment, the company must suspend selling the equipment and withdraw the equipment already supplied to customers. Differences Between RED and FCC Certificates The CE RED standard is valid in 28 EU countries. In addition, it is voluntarily accepted by some other states. Its standards are quite strict and include requirements for product safety but do not set limits on the frequency range of the equipment. The need for the CE RED marking arose because of the difference between the standards and the respective testing procedure and the general CE rules. The RED directive focuses specifically on intentional emitters, that is, devices that purposefully use radio waves to perform their primary function. For testing, a comprehensive approach is applied, which includes assessment of the convenience, safety, efficiency, and reliability of the device. The FCC certification is mandatory for radio equipment sold in the United States. Its requirements are less strict. For example, testing is not required for products that operate at frequencies less than 9 kHz. In addition, safety standards are set by another regulatory agency (OSHA). However, the testing procedure is stricter, and tests may be conducted only by laboratories accredited by the federal agency. Easy CE RED Certification with 360Compliance Our company will help you bring your electronic products to the markets of the European Union, Australia, and other countries. We offer a full range of services related to CE RED certification from drawing up a work plan to obtaining documents. We offer transparent prices, clear service timelines, and full technical support at all stages of the procedure. Submit an application online to learn more about RED certification.
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