Compliance with Requirements
Modules of Conformity
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The EU is an important market for U.S. exporters in the healthcare sector. The U.S. exported over $19.4 billion in medical devices to the EU in 2017 (representing 38% of the total export market), and in the pharmaceuticals sector, U.S. exports to the EU totaled $35 billion. 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.
Healthcare Policy Issues
The new European Union (“EU”) Medical Device regulations (“MDR”) entered into force on May 25, 2017, at which date the phase-in periods began. Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices will apply after three years (spring 2020) and five years (spring 2022), respectively. The purpose of these new regulations is to establish a more modernized and strengthened regulatory framework to ensure better protection of public health and patient safety.
The new regulations are expected to improve the EU medical device regulatory system in the following ways: (1) stricter premarket control for high-risk devices via a new scrutiny mechanism with the involvement of experts at the EU level; (2) reinforcement of the criteria for designation and processes for oversight of Notified Bodies; (3) inclusion of certain aesthetic devices, which present the same characteristics and risk profile as similar medical devices under the scope of these regulations; (4) introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance; (5) improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification (“UDI”); (6) introduction of an “implant card” containing information about implanted medical devices for a patient; (7) reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorization of multi-center clinical investigations; (8) strengthening of post-market surveillance requirements for manufacturers; and (9) improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.
The European Commission (“EC”) has stated that the reasons for the new regulations arise from problems with diverging interpretation of the current Directives as well as the notable incident concerning past fraudulent production of the PIP silicone breast implants that exposed weaknesses in the legal system in place at the time and damaged the confidence of patients, consumers, and healthcare professionals of medical device safety.
Legislative revision has consolidated the role of the EU as a leader in the sector over the long-term. The new regulations are intended to ensure a consistently high level of health and safety protection for EU citizens using these products, the free and fair trade of medical products throughout the EU, and the adaptation of EU legislation to address significant technological and scientific progress occurring in the medical device sector.
Despite EU's receptiveness to new technologies and regulatory improvements, barriers to expanding U.S. industry’s market share exist, including cost-containment measures and strong market competition. There appears to be a trade-off as these new regulations may benefit patients and provide stricter controls on high-risk medical devices, and more inspections by Notified Bodies and Competent Authorities may lead to improvements in the quality and safety of products, while industry is concerned that the more stringent regulatory requirements could prolong the time it takes for new products to get to market and concerned about adjusting to the new MDR.
Momentum in the EC on e-Health (referred to as Health IT in the United States) regulation has slowed in the past two years, in part due to the Directorate General for Communications Networks, Content and Technology (DG CONNECT) recently moving a significant portion of their operations from Brussels to Luxembourg. Recent publication of the Digital Single Market blueprint from the EU may increase e-Health policy initiatives, but (as of mid-July 2018) it is too early to cite specific topic areas of focus.
While aging populations will continue to drive pharmaceutical demand, cost containment remains a priority for Member State governments in Europe and will slow market growth. Countries are also exploring strategies to cooperate in pricing negotiations, such as through joint-purchasing groups and information exchanges. Such arrangements may be positive for industry to the extent that they accelerate access in certain markets. The EC is also discussing possibility of developing an EU-wide health technology assessment (“HTA”) review process, although such ideas are unlikely to move forward in the short-term.
EU debates surrounding intellectual property (“IP”) incentives raise concerns for industry. In May 2018, the EC published a proposed amendment to the regulation concerning the supplementary protection certificate for medicinal products. The amendment would allow EU generic and biosimilar companies to manufacture a generic or biosimilar version of a medicinal product still protected by an EU supplementary protection certificate (“SPC”), provided the product is intended solely for sale in a non-EU market where such protection has expired or never existed. Innovative companies have expressed alarm that such proposals would weaken the EU’s commitment to IP and reduce investment in research and development.
Brexit negotiations also continue to create regulatory uncertainty in the sector. The upcoming relocation of the European Medicines Agency (“EMA”) from London to Amsterdam following Brexit may cause delays in the drug approvals process. Although UK politicians have voted for the country to remain an active participant in the agency, it is not clear such an outcome is possible.
Medical and In-Vitro Devices
The EU has just completed a significant step in further harmonizing and updating its classifications and risk-based management of medical devices across the 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). With the May 2017 adoption of the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVD) regulations, the EU consolidated its previous three separate directives on implantable, non-implantable and in vitro diagnostics medical devices into two regulations. This consolidation and transformation of the directives into regulations will provide more consistency across the EU member states in compliance requirements across the product lifecycle. The implementing requirements will also be legally binding, increasing the compliance and liability requirements for both manufacturers and their authorized representatives.
The MDR becomes fully applicable in June 2020 and the IVD in June 2022. Devices currently compliant with the existing directives can be sold by U.S. companies to their authorized representatives (AR) until 2024 and by their ARs until 2025 provided that MDR and IVD’s CE marking have been renewed before 2020. However, companies should consider well in advance of these dates, if they will need to re-register their device, as there may be delays and other issues in the first years of the implementation of the new regulations.
With these new regulations, there will be fewer certification requirements for lower risk devices, but for higher risk medical devices, as well as in vitro devices there will be additional pre- and post-market requirements, both for certification and reviews of clinical data. Under the new legislation, the authorized representatives of medical device producers, who do not have a legal presence in the European Union, will be held jointly liable with producers for the products they place on the EU market. Industry representatives reported concerns about the possibility that not all Notified Bodies and Authorized Representative may keep pace with these changes, and could therefore withdraw from the market.
U.S. companies importing to the EU may wish to track the anticipated changes in the requirements at: https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_en
U.S. companies may also wish to engage with their Notified Bodies and Authorized Representatives on their plans following the changes. The EC maintains the following website for authorized Notified Bodies: http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=country.main
Until the EU fully transitions to the MDR and IVD Regulations, 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:
Cross-Border Collaboration on Procurement, Health Technology Assessments and Pricing
Within the EU, management of healthcare systems and budgets is the responsibility of the member states. However, with pressure on national budgets increasing, there is increasing interest in resource sharing and cross-border collaboration on issues such as joint plans for vaccination coverage across the EU and integrated national plans on management of chronic diseases. This may even extend to joint procurements for some healthcare products and services across some of the smaller states. In this same vein, in 2016, the European Commission commissioned a pilot through 2020 of joint Health Technology Assessments (EUnetHTA), which may eventually transition into an EU-level agency. To date, the pilot has focused on medical devices, with a pharmaceutical pilot announced in early 2017. More information is available at: http://www.eunethta.eu
Known as the “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. It is an indication to inspection authorities that the product complies with the directives.
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, IIa and IIb 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: https://ec.europa.eu/growth/sectors/medical-devices/guidance_en
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.
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 one 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 IIa or IIb 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: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0082:0128:EN:PDF
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 has been adopted in 2017 in tandem with the new proposed medical device legislation.
The European Commission is currently finalizing all the implementing and delegated acts needed for the proper implementation of the new legal framework. 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 visit: https://ec.europa.eu/health/home_en
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: https://ec.europa.eu/growth/sectors/medical-devices/guidance_en
The revision of directive 2004/40/EC on worker exposure to electromagnetic fields was finalized in June 2013 with the adoption of 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.
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 electrical and electronic equipment waste 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 entered into the scope of the RoHS directive as of 22 July 2014; for IVD the date was 22 July 2016. Other 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.
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).
The impacts of Brexit on pharmaceutical market authorizations are not yet clear. The European Medicines Agency will relocate to Amsterdam (Netherland). It is still unclear if medicines which have been granted marketing authorization in the U.K. may continue be sold in the rest of the EU. In the interim, the EU continues its efforts to move towards mutual recognition (MR) of pharmaceutical inspection processes, with the U.S. and other countries. The U.S. MR agreement with the EU was signed in January 2017 and will be rolled out incrementally across the EU member states. Other member states will be added in future years, following U.S. FDA inspections, with all potentially completed by the end of 2019. The EU will also be introducing new reporting requirements for 1) pharmaceutical clinical trials and 2) medicines authentication system, which will become operational in 2019.
The EU continues to move towards standardization and interoperability of eHealth solutions to promote interoperability of electronic health data across the member states. A network of national contact points for eHealth for the exchange of patient summaries and e-prescriptions started in 2017, with a view to expansion over the next three years, including recommendations for patient access.
AdvaMed, Advanced Medical Technology Association (http://advamed.org)
Medtech Europe (formerly Eucomed, Medical Technology, and Edma, European Diagnostics Manufacturers Association (http://eucomed.org and http://edma-ivd.eu)
COCIR, European Radiological, Electromedical and Healthcare IT Industry (http://cocir.org)
European Commission guidance on medical devices. Please note that these guidance documents only reflect the views of the European Commission. They are not legally binding like decisions of the European Court of Justice and can be challenged by Member States authorities or competitors.
CE marking (http://go.usa.gov/DfPm)
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