Compliance with Requirements
Modules of Conformity
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As the European Union (EU) does not have a Food and Drugs Administration (FDA), the task of harmonizing requirements and regulating medical devices is handled by the European Commission in close cooperation with Member State’s Health Authorities. The purpose of the EU harmonization effort is to merge the differing national requirements into one law which will be applied throughout the European Union. Legislation adopted through this process covers implantable, non-implantable and in vitro diagnostics medical devices in three separate directives that provide manufacturers the basics to certify their compliance with EU-wide safety requirements.
The following EU directives are in force throughout the European Union consisting of 28 Member States (Austria, Belgium, Czech Republic, Croatia, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, the Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Romania, Bulgaria and the United Kingdom):
The directives have been supplemented over time by six modifying and implementing directives. The last technical revision was Directive 2007/47/EC, which entered into force on March 21, 2010. The main changes introduced by this directive impact medical devices and active implantable medical devices. New elements include:
Since directive 2007/47/EC is not easy to read, the changes have been merged with the original directives to create a single, readable text which is up-to-date. The consolidated versions as well as guidance can be downloaded at:
Known as “new approach” directives, these directives outline a set of “essential requirements,” rely on use of voluntary EU wide harmonized standards, and offer a choice of conformity assessment modules. The distinguishing feature of new approach directives is CE marking, which is a conformity mark, affixed to the product, the instructions for use and the packaging, an indication to inspection authorities that the product complies with the directives.
Exception to CE marking
While CE marking is generally required on all medical devices, there are a few exceptions. All custom made implantable and non-implantable devices and devices for clinical investigations are subject to a different conformity assessment module which does not require CE marking at the end of the process. In vitro diagnostics for performance evaluation or research purposes only are not subject to the IVD directive although they may be subject to national requirements. In general, devices shown at trade fairs, exhibits, for demonstrations etc do not need to have CE marking. However, it is recommended to indicate clearly that non-CE marked devices are for demonstration purposes only.
Manufacturers should note that the differences in regulatory approach between the EU and the U.S. mean differences in classification and compliance verification. It would be wrong to assume that meeting the requirements for the U.S. market would satisfy the EU requirements. To illustrate this point, hospital beds including accessories, according to FDA guidance, are either Class I or II depending on the type of bed. In the EU, hospital beds and accessories are classified as Class I devices, allowing self-certification. In addition, the beds and their accessories would have to be considered separately, each as medical devices in their own right, especially when such items are sold separately.
The AIMD directive has but one class and does not allow self-certification. The medical device directive covers four classes, ranging from Class I, II a and b to Class III. Only Class I devices can be self-certified. Manufacturers have to involve the services of a notified body in all other cases, and sterile Class I devices or those with a measuring function must also use a notified body. The IVD does not distinguish classes but rather groups: general tests, self-testing kits, and Annex II lists A and B. For simple tests, self certification is usually an option. To help with classification in case the annexes in EU directives are difficult to interpret, the Commission has published new guidance: Guidance on the classification of medical devices.
For the majority of medical devices, the purpose is obvious: pacemakers, endoscopes, syringes and wound dressing are clearly to be used for medical purposes. Products where the intended purpose is not so clear are known as borderline products and they may be subject to several directives. For example, a scale to weigh patients in a hospital would be subject to both the non-automatic weighing scale and the medical device directives. Disinfectants for exclusive use with a medical device may be classified as an accessory to a medical device because the intended purpose is medical rather than general. The intended purpose is usually supported by appropriate statements on the company’s website or in promotional literature. It is possible to get an official interpretation to clarify borderline products but manufacturers should be able to make the determination in most cases themselves by using the guidance provided by the Commission.
For more information, please review the Commission’s guidance on borderline products, updated June 2013, Here.
Compliance with Essential Requirements
The “essential requirements” for the protection of health, safety and environmental concerns form the core of the directives. They cover risks and hazards that may occur at the design, production and handling stages. The manufacturer has to address the essential requirements which apply to a product and identify relevant risks for the patient. Non-relevant essential requirements do not have to be considered. As an example, manufacturers of arm braces made of stretch fabric would have to consider the essential requirements related to “compatibility between the materials used and biological tissues,” in other words, the fabric’s potential to cause skin allergies. A non-relevant requirement for arm braces would be “protection against radiation.” Choice of packaging is an essential requirement for prepackaged devices, as damage resulting from mishandling could have an adverse impact on the device making it harmful for the patient upon use. These are just examples, bearing in mind that there are many other elements to verify and that the manufacturer should carefully review the complete list of essential requirements.
Use of EU-Wide Harmonized Standards
The task of complying with essential requirements can be simplified by voluntarily using EU-wide (EN) harmonized standards. The risk assessment management standard which facilitates the initial checking of the relevant essential requirements is ISO/EN 14971. Manufacturers may also establish their own checklists for risk assessment of medical devices.
Other than the risk assessment standard mentioned above, the Commission has listed over hundred EU-wide harmonized medical device standards addressing various essential requirements. These standards have been developed and/or identified by the European standards organizations. They are often based on international standards. References to EN standards are published in the Official Journal (the EU equivalent of the U.S. Federal Register). As a result, the standards are uniquely linked to EU legislation and are known as harmonized standards. Use of EN harmonized standards gives “presumption of conformity.” When a manufacturer opts not to use an EN harmonized standard or prefers to design/manufacture to other standards, then the manufacturer has to show in great detail how their medical device meets the essential requirements in EU medical device legislation. All other existing standards not published in the Official Journal are either national or industry standards.
Modules of Conformity Assessment
To facilitate acceptance of the final product as meeting EU requirements, the manufacturer will have to choose a conformity assessment module as described in the annexes of EU medical device legislation. The choice of the module is determined by the classification and the preference of the manufacturer for a given module.
The conformity assessment modules address the design and production stages. For design, the manufacturer must provide the evidence of how the device meets the essential requirements. For production, the manufacturer has to put in place and document a quality system to ensure continuity in complying with the essential requirements.
Low risk products, such as Class I medical devices or self-test kits, generally allow self-certification based on conformity assessment module A which consists of establishing a Declaration of Conformity and compiling a technical file. All modules between B and H combine design and production compliance such as type examination and verification of manufacturing to type based on technical file inspection (modules B and F) or full quality assurance (module H). As these are conformity assessment modules for higher risk products, the services of an EU notified body or U.S. based subcontractor will be required to some degree depending on the classification.
Roles of a Notified Body
All active implantable medical devices and certain types of IVDs as well as medical devices belonging to Class II a or b or higher require the involvement of a notified body, the official term for accredited test laboratory based in the EU. Only notified bodies in the European Union can make the final assessment of conformity certification in accordance with EU directive(s). A U.S. based subcontractor of an EU notified body, such as UL or Intertek Testing Services, can also handle the tests for certification, but the certificate of conformity will still have to be supplied by the EU based notified body.
The technical file contains all relevant information to support the claims of compliance with EU requirements such as a general description of the product, documentation of the quality system, design information, list of standards used, result of design calculations/inspections, test reports, performance evaluation data, sample of label and instructions for use, and Declaration of Conformity. It is to be kept either by the manufacturer or his/her authorized representative with the understanding that it should be quickly accessible upon request from an official national inspection authority.
Declaration of Conformity
Among the final steps in the CE marking process of medical devices is the drawing up of a Declaration of Conformity which consists of name and address of the manufacturer and/or authorized representative, product name, type, model number and any relevant supplementary information, the reference numbers of standards, the date, a signature with title and a statement regarding responsibility of manufacturer or authorized representative. By applying the CE marking on the product, packaging and on the instructions for use, which can be done either by the manufacturer or his importer/distributor, the manufacturer has completed the CE marking process.
Manufacturers outside the EU have to identify an EU-based authorized representative unless they have a registered business in the European Union. The primary task of the authorized representative is to be the point of contact for the national health authorities of the Member States. The representative will have to notify the national authority in the country of residence whenever a new Class I device is brought on the EU market. Some national authorities have standardized forms on their website. In addition, the authorized representative’s name must be mentioned on the Declaration of Conformity.
The arrangement between the authorized representative and the manufacturer is purely administrative and subject to a commercial contract specifying the role that can be limited (authorized representative only) or broader (importer/distributor). Details about the responsibilities of manufacturers and authorized representatives can be found in the new legislative framework which covers all CE marking legislation.
Other than single notification, authorized representatives or manufacturers typically also register devices in individual member states. In the future, registration will become easier. With the Commission’s 2010 Decision to enforce use of Eudamed—the EU-wide database for devices on the market—registration of in vitro diagnostics in each country became redundant. The system for medical devices, however, will remain unchanged for the time being. Exporters/authorized representatives will still have to register their devices nationally until and when the Commission decides to move to a centralized registration for manufacturers of devices. In the meantime, Eudamed will be of use to member states for internal communications and for post-market surveillance purposes. To facilitate registration, the EU encourages use of the Global Medical Device Nomenclature (GMDN) based on EN/ISO standard 15225.
As the EU regulator allows manufacturers to self declare conformity, with or without involvement of an accredited test laboratory, verification of compliance to ensure safety of consumers is left to the Member States after the products have been brought on the market. As Member States each have their own system, it is possible that some countries grant extensive inspection powers to their national customs service where others may focus their resources in local inspections. When caught in an infraction, the measures imposed on manufacturers may vary from a simple warning to a hefty fine or complete withdrawal from the market, depending on the type of infraction.
EU medical device legislation requires that Member States put in place safeguard procedures. In case of an incident involving injury or death, the Commission will be notified, thereby triggering an EU-wide rapid alert system. The Commission has been putting more emphasis on post-market surveillance, with a goal to strengthen the infrastructure of cooperation among national inspection authorities.
With the adoption of measures in September 2013, the Commission further tightened control by strengthening the criteria for the designation and supervision of notified bodies and addressing the tasks to be fulfilled by notified bodies when conducting audits and conformity assessment procedures. These measures have proven to be successful.
Coming Soon: New Regulatory Framework for Medical Devices
The existing medical device directives (MD and AIMD) are currently being reviewed following the 2008 public consultation. The purpose is to recast the regulatory framework. A proposal for a new framework was released in September 2012. The review focuses on extending the scope, introducing pre-scrutiny system for high risk devices, and improving the vigilance and post-market surveillance system.
In June 2010, the Commission launched a separate public consultation to review in vitro diagnostic device legislation. The review focuses on scope, classification and conformity assessment methods of IVDs, among others. The proposed legislation was released in September 2012 and is still undergoing review in tandem with the new proposed medical device legislation.
The European Council and European Parliament are currently finalizing the review. The new text is likely to be published on the Official Journal of the EU in early 2017. New measures should be effective from 2020 for MD and AIMD and 2022 for IVD.
For more information about the review of existing legislation, please click here.
Medical Devices and Machines
Overlap with the new machinery safety directive 2006/42/EC has been clarified for medical devices that are also machinery. Only one single conformity assessment is required under the medical device directives 93/42/EEC and 90/385/EEC. The risk assessment to be carried out is the risk/benefit analysis as set out in the essential requirements of the directives concerning medical devices. Harmonized standards for medical devices which are also machinery should cover in their scope any requirements of the machinery directive that are applicable to the devices. Such standards will be reviewed and amended or revised if needed.
Interpretation of the relation between the revised Directives 90/385/EEC and 93/42/EEC concerning (active implantable) medical devices and Directive 2006/42/EC on machinery can be found here.
The revision of directive 2004/40/EC on worker exposure to electromagnetic fields was finalized in June 2013 with the adoption of Directive 2013/35/EU. The directive sets exposure limits for workers but allows a derogation for MRI. Stakeholders affected by this directive successfully lobbied the EU and Member States in order to obtain an exemption for MRI equipment. A practical guide covering procedures for hospital workers exposed to electromagnetic fields will be developed.
The amended EU directive on units of measurement (the so-called “metrics” directive 80/181/ EC) entered into force on January 1, 2010, which means products must bear metric units of measurement. Use of supplementary units, such as U.S. customary inch-pound, are also allowed.
Specific requirements for labels are included in medical device directives. As for choice of language on labels, EU medical device legislation defers to Members States. Please contact our CS posts in other countries for more details.
Medical Devices Using Animal By-Products
The occurrence of bovine spongiform encephalopathy (BSE) in the European Union led to stringent measures regarding traceability of tissues of animal origin for use in medical devices. Risk assessment was addressed in guidance and standardization. The Commission adopted an animal by-product regulation in 2002, repealed in 2009 by Regulation 1069/2009, which covers use of raw material of animal origin for non-food use. Medical devices are subject to specific transport and labeling requirements. The material has to be sourced from approved plants and the process has to be documented. For more information, we suggest you contact the Foreign Agricultural Service at the U.S. Mission to the European Union.
Growing mountains of waste of electrical and electronic equipment have forced the EU to consider ways to reduce, recover and recycle packaging and appliances. Also, the use of hazardous substances has led to environmental damages; therefore certain substances such as lead or mercury have been banned. Those issues have been tackled by the Waste of Electrical and Electronic Equipment legislation (WEEE) and the Restriction of Hazardous Substances in Electrical and Electronic Equipment legislation (RoHS).
Medical devices will fall within the scope of the RoHS directive as of 22 July 2014; for IVD the date is 22 July 2016. Others laws such as the Waste Electrical and Electronic Equipment (WEEE) directive require OEM manufacturers to dispose of products they manufacture in an environmentally responsible way once the equipment reaches end of life. Medical devices are covered by this directive but with a specific exemption today for “implanted and infected medical devices,” http://go.usa.gov/DfQP.
Chemical Substances and Mixtures in Medical Devices
Medical devices containing or consisting of chemical substances and mixtures are subject to specific requirements under the Registration, Evaluation, Authorization and Restrictions of Chemicals (REACH) Regulation and the Classification, Labeling and Packaging of substances and mixtures (CLP) Regulation. REACH entered into force on June 1, 2007. It changes the former legislative framework for chemicals to ensure a high level of protection of human health and the environment. REACH makes industry responsible for assessing and managing the risks posed by chemicals and providing appropriate safety information to their users. Under REACH, the EU can also take measures to ban the use of highly dangerous substances. CLP aligns previous EU legislation on classification, labeling and packaging of chemicals to the UN GHS (Globally Harmonized System of Classification and Labeling of Chemicals).
National health authorities
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Notified Bodies/Conformity Assessment Bodies:
U.S. Commercial Service Contact Information
Name: Antonio Dai Pra
Position: Market Access Specialist
Phone: (32-2) 811-5001
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