Medical device regulatory strategy – US vs. EU

Developing an efficient regulatory strategy is crucial for the success of a company because a medical device can only be brought to market if all regulatory requirements are met. Often the efforts and complexity of obtaining and maintaining approval or certification of a medical device are underestimated. And choosing the US or EU as the first market needs careful consideration of the regulatory implications.

Replaces version of 5.11.2020

Key takeaways

• The regulatory strategy must support the market strategy. As such it should be outlined very early in the project and consider multiple aspects beyond the product itself, including resources and market understanding.
• The principles on which medical devices are authorized to be placed and maintained on the market in the EU and US are the same but the approaches to market authorization are very different. You should not try to extrapolate assumptions from one jurisdiction to the other.
• The same product might qualify as medical device in the EU and not in the US or vice versa. Even if viewed as medical device in both jurisdictions, the classification rules and compliance requirements can significantly diverge.

Contents

Regulatory considerations in strategic market choices

Any company who wants to market a medical device should always weigh the commercial attractiveness of a market against its regulatory requirements, as the complexity of getting and maintaining regulatory authorization for a medical device might result in exploding development costs and extended timelines. Worse yet, the product may not reach the market at all.

The regulatory strategy is intertwined with the marketing strategy, as gaining access to markets is preceded by regulatory authorization. It is therefore necessary to establish the regulatory strategy in the early phases of a project. And, to anticipate the workload and implications of getting a device cleared in a particular market, companies need to understand the local regulatory requirements applicable to their devices.

Contrary to medicinal products, the rules governing medical device’s definition, classification, requirements, technical documentation, and product-related processes are not harmonized across jurisdictions, despite the efforts by the International Medical Device Regulators Forum (IMDRF) to align diverging practices. This organization groups medical device regulators from major jurisdictions (including US and EU) “to accelerate international medical device regulatory harmonization and convergence.” Yet, only a few recommendations from the IMDRF have been adopted as they are by all its members, e.g. adverse event codes and terminology.

In our consultancy role, we see more and more cases where the US is preferred over the EU as the initial market.

Now, in almost all markets worldwide, the device’s risk classification determines the level of regulatory scrutiny. To classify a medical device (incl. in-vitro diagnostic devices, IVDs), the manufacturer must have established its intended purpose and intended user, as well as a comprehensive list of device functions. Therefore, even if it is important to have an overview of the regulatory implications in the early phases of device development, a meaningful regulatory strategy can only be completed once the outputs of the initial phase of product development become available.

In our consultancy role, we see more and more cases where the US is preferred over the EU as the initial market, due to the additional restrictions and uncertainty brought into the CE-marking process by the new Regulations (EU) 2017/745 on medical devices (EU MDR) and 2017/746 on in-vitro diagnostic devices (IVDR). Yet, there is no one-size-fits-all strategy. Market choices must be established based on the characteristics and features of the device, the manufacturer’s company setup, and the applicable regulatory controls. The following chapters are intended to support your strategic decisions, with the basic regulatory requirements in the EU and the US, as well as the main differences.

Other regulatory-related factors to be considered when planning the market entry include:

• Qualified regulatory and quality staff
  Gaining and maintaining market approval requires effort. Moreover, keeping abreast of regulatory requirements across markets can be difficult, particularly when the regulatory basis only exists in local languages that are not spoken by the regulatory staff. This happens even within the EU, as local legislation or competent authority’s positions in most Member States are rarely translated into English. And Quality Management Systems need to be properly adapted to cover the regulatory specificities in the different markets where the devices are to be sold. Companies should have sufficient and qualified regulatory and quality resources, whether in-house or contracted, to ensure understanding of and compliance with the regulatory requirements in the pre- and post-market phases.
• Medical device market understanding
  Even though some markets are well known for high-profit margins in healthcare products, some countries are more attractive for a specific product than others. As part of the decision-making process, it is important to gather information on aspects like: distribution channels (e.g. potential for distance sales, restrictions on dispensation of medical devices subject to prescription, restrictions on “private labelling” or reused devices, and any unauthorized distribution practices), reimbursement policies, and similar devices on the market (which would reduce the level of novelty of your device and might simplify the proof of evidence needed for approval).
• Synergies in regulatory approvals
  Sometimes, regulatory authorization in one country/region can be used to support authorization in others. For example, CE-marking is a pre-requisite for regulatory approvals in most Middle Eastern and African countries. If those are markets of interest for your company, CE-marking might be the first step of choice. Also, there are ongoing proposals to have Switzerland and UK accept US FDA approval/clearance of medical devices in addition to CE-marking. If these proposals are adopted, it could make sense to consider US FDA approval as a first step. Another example, Quality Management System’s certification to ISO 13485 is a basis for CE-marking as well as for approval in countries such as Australia, Canada, and Japan. Also, it forms the basis for the Medical Device Single Audit Program (MDSAP) that opens the door also in Brazil or USA.

What aspects of your regulatory strategy differ between the US and EU?

It may seem obvious, but it tends to be overlooked: the US is a country, whereas the EU is the political and economic union of 27 European countries (EU Member States).

• The US has a definite set of federal legislation on medical devices (in the US Code, USC, and Code of Federal Regulations, CFR), a single competent authority (US FDA), and a single language required for medical device labelling and documentation (English).
• The EU has established a single market through rules that apply to its 27 Member States as well as to other European countries adopting EU legislation via different types of bilateral agreements (i.e., EFTA countries, Turkey, and European microstates like Andorra, Monaco and San Marino). These countries have adopted CE marking as the mutually recognized conformity assessment process for medical devices. However, each of them has its own competent authority and mandatory labelling/documentation language(s). And the oversight for CE marking is not conducted by the national competent authorities; it is delegated to third-party accredited organizations, called Notified Bodies. Furthermore, the United Kingdom (UK) left the EU in December 2019 and has set its separate process for medical device authorization. Also Switzerland, with the disruption in the mutual recognition with the EU, has now additional requirements, like the need for a Swiss Authorised Representative.

The regulatory strategy for a medical device meant to be launched in the US and EU, or rather in CE-marking accepting countries, needs to account for their potentially significant regulatory differences. Particularly in terms of:

• Device qualification
  The same product might fall under the definition of medical device in the US and not in EU, where it might correspond to a cosmetic, pharmaceutical, consumer product, or another regulatory category. Special caution is recommended for devices intended to administer drugs, since drug-device combination products are regulated under a single set of rules in the US and overseen by a “leading” competent authority whereas they are subject to dual legislation and oversight in the EU.
  For more details, see “What is a medical device in the US and EU?“
• Device classification
  The same medical device might be considered a low-risk device exempt from regulatory authorization in the US, and medium/high risk in the EU, subject to Notified Body scrutiny. In particular, the approach differs in the classification of medical standalone software — i.e. SaMD (software as medical device) in the US, and MDSW (medical device software) in the EU. For more details, see “What determines the regulatory pathway in the US and EU?“
• Compliance ownership
  Whereas both US and EU require a local representative when the manufacturer is based outside the jurisdiction, the role and duties of the US Agent vs. the EU Authorized Representative (EAR) differ significantly. Even more important is the different definition of “manufacturer” in both jurisdictions and the fact that a US distributor selling a device under its name or co-packaging several devices might be viewed as the manufacturer in the EU, and be responsible for CE marking.
  For more details, see “Who can sell a medical device in the US and EU?“
• Compliance requirements
  The level of evidence required to prove safety and performance of the device (e.g. clinical data, absence of certain chemicals) might be higher in the EU than in the US for the same medical device. Also, certain processes required to maintain compliance might apply in the EU and not in the US (e.g. proactive post-market surveillance). And the non-standardized UDI systems have finally made it impossible to have the same outer pack label for US and EU.
  For more details, see “How does market authorization compare in US vs. EU?“

What is a medical device in the US and EU?

The definitions of “medical device” are set forth in the corresponding legislation, and are relatively similar between the US and EU, with the EU following IMDRF’s definition more closely.

US	EU
Regulatory Basis
For both IVDs and non-IVDs: Section 201(h) of the US Federal Food, Drug and Cosmetic Act (FD&C Act), corresponding to Section 321 of the United States Code (USC)	For non-IVDs: Article 2(1) of Regulation (EU) No. 2017/745 on medical devices (EU MDR) For IVDs: Article 2(1) of Regulation (EU) No. 2017/746 on in-vitro diagnostic devices (IVDR)
Legal Definition
“An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: 1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, 2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or 3. intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).”	In the EU MDR: “any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: 1. diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease 2. diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, 3. investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, 4. providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be medical devices: devices for the control or support of conception; products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point”   In the IVDR: “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following: (a) concerning a physiological or pathological process or state; (b) concerning congenital physical or mental impairments; (c) concerning the predisposition to a medical condition or a disease; (d) to determine the safety and compatibility with potential recipients; (e) to predict treatment response or reactions; (f) to define or monitoring therapeutic measures. Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;”

In practice, these definitions are rarely sufficient because the types of products excluded from the scope of the legislation need to be also considered. Moreover, these definitions do not provide details that are needed for the qualification of new or ‘borderline’ products, i.e. those without a clear medical device intended purpose.

To help manufacturers determine the regulatory category of a potential medical device, the following regulatory qualification guidelines have been issued:

• In the US: How to determine if your product is a medical device. It recommends that, after verifying if the product meets the above definition of a medical device in consideration of its intended use, the manufacturer determines if an appropriate product classification exists for the product. Finding an existing classification that describes the product’s intended use or design is a good indicator that the product might be a medical device. To that end, the fastest approach is to browse the US FDA’s product regulations in Title 21 of the US Code of Federal Regulations (21 CFR) Chapter I, Subchapter H, subparts 862 through 895, where generic types of medical devices are sorted by clinical application.
• In the EU: The Manual on Borderline and Classification under the EU MDR and IVDR is meant to be the main reference guideline. This manual shall be progressively populated with positions from the EU Commission on tricky qualification cases and does not prove really helpful. If a given case is not described, the alternative is to consult the former manual that had been maintained under the previous legislation, with numerous examples, but it is not a reliable basis since the definition of medical device and the scope of application of the EU MDR differ from those in the old Directives. Only on a couple of key topics has the EU’s Medical Device Coordination Group (MDCG) published guidance documents: MDCG 2019-11 on the qualification and classification of medical device software (MDSW), and MDCG 2022-5 on borderline issues between pharmaceuticals and medical devices. MDCG guidelines are, however, not legally binding and in case of disagreement only the European Court of Justice (ECJ) can issue binding interpretations of EU law.
  

Today medical devices for veterinary use in the EU are simply consumer products.

After considering legal definitions, scope exclusions, and qualification guidelines, you might still find that your product is regulated as a medical device in one jurisdiction and not in the other. Some examples include:

• Animal health: medical devices for veterinary use are covered in the definition of medical device in the US but fall outside the scope of the definition in the EU. There used to be a bespoke EU Directive (Dir. 84/539/EEC) that was repealed in 2008 but never replaced, and today medical devices for veterinary use in the EU are simply consumer products.
• Standalone software: web-based tools or mobile apps that either help patients identify potential conditions from common symptoms (i.e. symptom checkers) or provide patient-specific preventive recommendations are medical devices in EU, which are likely to fall under Class IIa or even higher under the EU MDR, per MDCG 2019-11. In the US, the FDA has taken a pragmatic approach to medical software and, per their Policy for Device Software Functions and Mobile Medical Applications, decided to exercise discretionary enforcement (i.e. they do not enforce medical device requirements, incl. no 510(k) clearance) on patient health self-management software.
• Fitness equipment: whereas fitness equipment intended specifically to measure heart rate or breathing rate is a medical device in EU, gym equipment that contains an element that measures heart rate would not be a medical device because its primary purpose is as a piece of fitness equipment. In the US, all exercise equipment intended to redevelop muscle or as adjunct treatment of obesity are medical devices. This would include, for example, a rowing machine with measuring instrumentation (Class II device) and even non-measuring exercise equipment like parallel bars (Class I devices). Only equipment making no claims about a specific condition, i.e. making just claims about sustaining or improving a general state of health would be considered “general wellness products”.

What determines the regulatory pathway in the US and EU?

The type of regulatory scrutiny and market authorization needed depends on the medical device classification, which follows similar principles in the US and EU: devices are classified based on their inherent risk. The classification similarities have increased with the enhanced classification rules in the new EU MDR, e.g. on invasive devices for transient use, for which continuous use now needs to be considered, and the newly established classification rules for IVDs under the IVDR, in lieu of the former lists. 

In the EU, the manufacturer is responsible for determining the appropriate classification for its device, following the classification rules in Annex VIII of the EU MDR or IVDR, and for choosing the corresponding regulatory pathway.

EU medical device classes	Regulatory pathway (for CE marking)
For non-IVDs under EU MDR
Class I (low risk)	They can be CE-marked by self-declaration of the manufacturer, without the involvement of a Notified Body, once the manufacturer has compiled evidence of conformity with the relevant General Safety & Performance Requirements (GSPR) in EU MDR Annex I, in the form of a compliant Technical Documentation set.
Class Is – sterile Class Im – with measuring function Class Ir – reusable surgical instruments (low/medium risk)	Their conformity assessment process for CE-marking requires the involvement of a Notified Body only for the specific aspects: sterilization, measuring function, or reprocessing. The manufacturer needs to maintain a compliant Quality Management System and device Technical Documentation.
Class IIa (medium risk) Class IIb (medium/high risk) Class III (highest risk)	Their conformity assessment process for CE-marking requires full involvement of a Notified Body, who audits and certifies the manufacturer’s Quality Management System and device Technical Documentation.
For IVDs under the IVDR
Class A (low risk)	They can be CE-marked by self-declaration of the manufacturer, without the involvement of a Notified Body, once the manufacturer has compiled evidence of conformity with the relevant General Safety & Performance Requirements (GSPR) in IVDR Annex I.
Class B (medium risk) Class C (medium/high risk) Class D (highest risk)	Their conformity assessment process for CE-marking requires full involvement of a Notified Body, who audits and certifies the manufacturer’s Quality Management System and device Technical Documentation.

In the US, the FDA establishes the classification for generic types of medical devices (incl. IVDs), per classification panels corresponding to clinical applications. The classification for a given type of device is added to its Product Regulation in the corresponding section of Title 21 of the CFR according to their medical specialty and are assigned a 3-letter Product Code. The manufacturer merely takes the classification and regulatory pathway established in the applicable Product Regulation and, in case of uncertainty or disagreement with a given classification, an official request to US FDA for opinion can be filed through the 513(g) process.

US medical device classes	Regulatory pathway
Class I (low risk)	The devices in this class are mostly exempted from premarket notification to the US FDA and from Good Manufacturing Practice (GMP) per the Quality System Regulations (QSR). A list of exemptions is available from the US FDA website. For exempt devices, the only requirements that apply are: Quality System Regulation (21 CFR 820) compliance (and some Class I devices are even exempted from this, too) establishment registration, device listing, complaint handling & medical device reporting, and device labeling. When not exempted, a 510(k) Premarket Notification is required, provided substantial equivalence to an existing equivalent device (known as “predicate”) can be demonstrated. If that is not the case, a De Novo Classification Request must be submitted to the US FDA.
Class II (medium risk)	The devices in this class are mostly subject to a premarket notification to US FDA, i.e. via the 510(k) pathway, in case a predicate has been previously approved or via a De Novo submission in case there is no predicate. Just like for Class I devices, some Class II devices in the lowest risk range are exempt of premarket notification but not of Quality System Regulation (21 CFR 820) compliance.
Class III (high risk)	The devices in this class are subject to the strictest regulatory process, i.e. Premarket Approval (PMA) by the US FDA.

Note that the US FDA’s authorization under a PMA is an “approval” whereas under the 510(k) it is clearance of the substantial equivalence.

In addition, different types of 510(k) pathways exist:

510(k) type	Submission Details
Abbreviated 510(k) For device submissions that rely on: – FDA guidance document(s), – Demonstration of compliance with special control(s) for the device type, or – Voluntary consensus standard(s).	US FDA Guidance on How to Prepare an Abbreviated 510(k)
Special 510(k) For changes to a previously cleared device under 510(k) or DeNovo.	US FDA Guidance on How to prepare a Special 510(k)
Traditional 510(k) For any original 510(k) or for a change to a previously cleared device under 510(k).	US FDA Guidance on How to Prepare a Traditional 510(k)

Despite some classification similarities, your medical device might still fall under different risk classes in the US and in the EU. It is therefore important to ensure clarity on the classification and regulatory pathway in both jurisdictions.

In some cases, a classification difference might not result in a more cumbersome path to market in one jurisdiction than in the other. For example, a surgical lamp intended to illuminate the patient’s body as a surgical field would be a Class II device in the US, per product regulation 21CFR878.4580. In the EU, it would be a Class I active device, per EU MDR classification rule 13, thus subject only to self-declaration of conformity for CE-marking. In practice, by virtue of US FDA’s exemptions, the Class II surgical lamp in the US would not require a premarket submission and could be placed on the US market without regulatory oversight by the US FDA.

How does market authorization compare in US vs. EU?

For low-risk devices, the level of effort to place the medical device on the market is lower in the US. Although in the EU a Class I medical device does not need the involvement of a Notified Body for CE-marking, the EU legal manufacturer still needs to compile the corresponding Technical Documentation, including a clinical evaluation report as well as proactive post-market surveillance (PMS), and labelling translations in EU would add costs and logistic complexity to the supply chain.

For low-risk devices, the level of effort to place the medical device on the market is lower in the US.

For medium- and high-risk devices, CE marking used to be easier to achieve than US FDA clearance. This has changed with the new EU MDR/IVDR, which make it harder to bring or maintain a medical device in EU, particularly due to the revised classification rules, increased requirements for clinical evaluation, as well as to the fact that some aspects that used to be part of guidelines are now legally binding provisions. Although the fundamental requirements for medium- and high-risk devices are similar in both jurisdictions, their application differs.

• A device needs documented evidence of conformity with the applicable safety and effectiveness/performance requirements, following official guidelines and/or recognized standards, where available. Such evidence can be based on own data or on data from an equivalent device (“predicate” in the US) and must be compiled in the relevant dossier format, which is different in US (specific to the type of submission) from the EU (per EU MDR/IVDR Annexes II & III). 
• While the US FDA recognizes some international standards (i.e. “consensus standards”), a company willing to make a submission should identify the applicable official guidance documents, available online from the searchable webpage on US FDA guidance documents, which extensively and clearly cover requirements per types of products, topics, and type of guidance. In turn, CE-marking in the EU is mostly based on “Harmonised Standards”, i.e. recognized international standards under a given legislative instrument (i.e. the EU MDR or the IVDR), that establish requirements relative to a few types of devices (e.g. EN 14683 for surgical masks, EN ISO 21649 for needle-free injectors) or product-related processes (e.g. EN ISO 14971 on risk management, EN ISO 10993 series on biocompatibility, EN 62304 on software life-cycle processes). Where no EU harmonized standards exist, it is left at the discretion of the manufacturer to identify a relevant guidance document or non-harmonized standard, with the resulting risk of inappropriate choice. Similarly, “Common Specifications” (a set of technical or clinical requirements, where no or insufficient harmonized standards exist) are to be issued by the EU Medical Device Coordination Group (MDCG) but only a few have been published, e.g. those on products without medical purpose falling under EU MDR Annex XVI (e.g. color contact lenses, dermal fillers, liposuction equipment). In addition, the MDCG has been furiously producing guidance documents for the past couple of years (MDCG guidance documents), which has resulted in dozens of papers with scattered or partial information that requires significant regulatory monitoring efforts to ensure key requirements are not missed.

• Market authorization in the US entails the submission of the medical device dossier for review/approval by the competent authority, i.e. the US FDA. In addition, the US FDA inspects the manufacturer’s quality management system, noting that the term “manufacturer” in the US means the producer, and this inspection takes place in the pre-approval phase for PMA submissions. In the EU, there is no overarching competent authority for medical devices. Instead, Notified Bodies are private companies that represent the EU national competent authorities in the conformity assessment of medical devices, through audits of the technical documentation and the manufacturer’s quality management system prior to issuing the EU Certificates required for CE-marking, noting that the term “manufacturer” in the EU means the CE-mark owner. In some cases, timelines to achieve CE marking might turn out to be longer than those for US FDA authorization, due to the shortage of Notified Bodies designated under the new EU MDR/IVDR. For example, for a simultaneous submission of a medium-risk device to the US FDA under the Traditional or Abbreviated 510(k) program and to the selected EU Notified Body, a company could expect US FDA’s clearance within 4-6 months and CE-marking within 8-12 months.

Who can sell a medical device in the US and EU?

In both the US and EU, foreign manufacturers (i.e. entities not located in the territory) can hold regulatory approvals for medical devices but they need a local representative within the territory, and they can sell medical devices though an official local importer. However, the roles and duties of those entities significantly differ in the US and EU. So does the role of “manufacturer”. Specifically:

US	EU
Local Representative
A foreign manufacturer needs a US Agent. The US Agent has limited responsibilities, mainly as liaison agent between the FDA and the foreign establishment, and no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).	A foreign manufacturer can be the CE-mark owner (i.e. “legal manufacturer”) but it needs an EU Authorised Representative (EAR or EC-REP). The EAR bears significant regulatory responsibilities, per EU MDR/IVDR Art. 11, as it is liable for defective medical devices together with the foreign manufacturer, in case of non-compliance. Therefore, the EAR must verify and keep copies of conformity assessment documents. MDCG 2022-16 provides detailed information on this role.
Importer
A medical device that enters the US from a foreign country needs an Initial Importer located in the US. The Initial Importer must be staffed by individuals responsible for ensuring the compliance of imported devices with all applicable US FDA laws and regulations, and is subject to establishment registration.	A medical device that enters the EU from a third-country needs an EU Importer located in any country of the EU single market. The EU Importer is subject to substantial regulatory responsibilities, per EU MDR/IVDR Art. 13. These include compliance verification, post-market surveillance, and registration duties in the EU-wide database EUDAMED.
Manufacturer
In the US, the role of manufacturer is mostly associated with the producer. The role is not necessarily linked to the holder of US FDA’s market authorization. Per US FDA’s 21 CFR 820.3(o), Manufacturer means: “any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.” Repackagers and relabelers who place a device on the market under their own name are not considered manufacturers and can rely on regulatory approval/clearance obtained by another company.	In the EU, the role of manufacturer corresponds to the entity that owns the CE-marking, regardless of whether or not the company conducts any production.Thus, the EU manufacturer endorses the ultimate regulatory responsibility for compliance. The role is frequently referred to as “legal manufacturer” to differentiate it from a mere producer. Per EU MDR Art. 2(30) or IVDR Art. 2(23), Manufacturer means: “a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark.” Moreover, per EU MDR/IVDR Article 16, distributors and importers (or other persons) might assume the responsibility of the “legal manufacturer” if they sell the device under their name, modify the device’s intended purpose or its characteristics in a manner that affects the applicable requirements.

Given the above differences, your company might find itself in conflicting roles between the US and EU. For example:

• If you are a US manufacturer wanting to sell in the EU a device you produce but for which you are not the holder of a 510(k) clearance by the US FDA, you would be seen as the “legal manufacturer” in the EU and would need to generate your own proof of safety and performance for the device and adapt your quality management system to obtain CE marking.
• If you are a US private labeler or distributor who has re-packaged/re-labelled someone else’s medical device, you would be seen as the “legal manufacturer” in the EU.
• If you are an EU private labeler wanting to sell a device from the original manufacturer in the US, you could rely on the US FDA’s authorization obtained by the original manufacturer and would be considered a foreign relabeler/repackager.

Because medical device distribution chains can become very complex when several entities are involved, it is strongly recommended to verify your set-up with particular focus on whether you would be endorsing the regulatory responsibilities for compliance.

Manufacturers of medical devices who are not based in Switzerland require a Swiss Authorised Representative in order to place their products on the Swiss market.

Last, remember that the UK and Switzerland have now established separate rules regarding medical devices, which include the requirement for a local representative in lieu of the EU Authorized Representative, namely:

• UK Responsible Person (UKRP)
• Swiss Authorised Representative (CH-REP).

How can Decomplix help?

The first step consists of identifying the key target markets and evaluating the overall scale of the effort to gain market access through regulatory approval. This requires a detailed understanding of the regulatory framework as well as a well-constructed regulatory strategy plan, which defines the appropriate requirements, activities, and responsibilities.

Despite all the differences, there are some common regulatory requirements in the EU and the USA. In certain cases, details are crucial as they can significantly impact the responsibilities of different economic actors. Our team of experts will be happy to support you in the development of the regulatory strategy as well as in specific questions regarding the regulatory requirements for your medical device in the EU and the USA.

If you are looking for assistance in any step of the most appropriate regulatory strategy, here is how Decomplix can help.

If you need further information, please do not hesitate to contact us.

Further reading

•  The intended purpose – or, what does your medical device do?
• Certification of a Quality Management System according to ISO 134585
• Is my product a medical device in Europe? How to determine if your product requires medical device CE marking
• How to obtain a CE mark for a medical device
• CE marking for in vitro diagnostic devices under the IVDR
• Medical device software (MDSW) under EU MDR and IVDR
• Swiss authorised representatives for medical device manufacturers