Class I medical device requirements for manufacturers under EU MDR
Do you CE mark low-risk medical devices and are uncertain about the regulatory requirements and your level of compliance? Do you wonder whether your activities in the medical device distribution chain correspond to those of a “legal manufacturer” under European legislation? Here is all you need to know about it.
- Make sure that you know if you are a legal manufacturer of medical devices or not.
Run the manufacturer identification checklist in this article to find out.
- The requirements for Class I medical device manufacturers under the EU MDR have become stricter. Run the conformity checklist in this article.
- If still in doubt or unable to understand some of the concepts in this article, reach out to us for assistance.
Are you a medical device manufacturer under EU MDR if you “only” sell medical items?
You need to first assess the activities involved in your selling medical devices with regards to the definitions and requirements in Regulation (EU) No. 2017/745 on medical devices (EU MDR).
For example, are you marketing under your own trademark a medical device which has been designed and/or manufactured by someone else? If so, you are a medical device manufacturer. If not, you may still be.
A medical device manufacturer, according to the definition in EU MDR Art. 2(30), is anyone 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”.
The distributor merely supplies a medical device in the course of commercial activity up to the end user, irrespective of whether on return of payment or free of charge. The distribution activity is defined as “making available on the market” in EU MDR Art. 2 (27).
But a distributor, importer or other actor in the medical device supply chain may become a manufacturer if it “makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation. […]” per EU MDR Art. 16(1)(a).
The reality of the medical device commercial network in Europe, including Switzerland, is far more nuanced.
In our role as Swiss Authorised Representative, we see a significant number of companies who thought they were just medical device traders, distributors or “private labellers” and did not realize that their activities correspond to those of a medical device manufacturer, which is also commonly referred to as “legal manufacturer”, to differentiate this regulatory role from that of a manufacturing or production site.
This is frequently the case for companies selling protective gloves, masks, corrective spectacle frames, borderline wellness items, simple accessories for medical equipment, and software widgets.
Before even asking yourself whether or not you are a medical device manufacturer, you need to be certain that the products you sell are considered medical devices or accessories for medical devices under the EU MDR. Because medical device qualification is not always straightforward we recommend that you consult our blog article Is my product a medical device? How to determine if your product requires a CE Mark in the EU?
Checklist to determine if you are a medical device manufacturer
Once you are sure you are selling medical devices, the simplified checklist below may help you determine whether or not your activities are viewed as medical device manufacturer’s activities.
- Are you a third-party logistics (3PL) company providing more than just storage and transportation services for the medical devices you handle?
- Do you make any claims that may identify yourself as the manufacturer of the products you sell (e.g. on your website, on the product’s marketing materials, on the product’s labeling)?
- Do you sell the medical devices under your brand/trade name, or with your logo and/or corporate identity, without indicating your supplier as the manufacturer on the labelling (including marketing materials)?
- Do you sell the products for an intended purpose different from the one declared by your supplier?
(If you are unsure about the intended purpose, we recommend that you consult our blog article The intended purpose – or, what does your medical device do?)
- Do you issue a different Declaration of Conformity from the one received from your supplier?
- Do you add a CE mark to the products received from your supplier prior to selling them?
- Do you sell the CE-marked medical devices in the exact same packaging and with the exact same labelling (i.e. product labels and instructions for use) as you receive them from your supplier?
If you make changes to the labelling or packaging, are these changes limited to the activities covered by EU MDR Article 16(2)?
(If you are unsure about the extent of your repackaging or relabelling activities, we recommend that you consult our blog article Which MDR requirements apply to distributors of medical devices?.)
If you cannot categorically answer NO to ALL these questions, you should read on.
What are the implications of CE marking Class I medical devices?
The moment you are viewed as the “legal manufacturer” under the EU MDR, you endorse CE mark ownership, which means full responsibility for the safety and performance of the CE-marked medical device and for conformity with the EU MDR, regardless of whether or not you design, develop, and/or produce it yourself. Taking on the CE marking responsibility for a medical device is not just a declaration; it involves many actions throughout the device’s lifetime, which cannot be fulfilled by being a distributor or importer with a little more overhead.
Even if you simply purchase a finished medical device that has been designed, developed and produced fully by another company, as the “legal manufacturer”, you become responsible for the design, development and production already done and must exert control over these processes.
Affixing a CE mark on a medical device, including low-risk devices that classify as Class I under the EU MDR, is only possible after the manufacturer has verified that all the requirements in the EU MDR are fulfilled. These requirements entail compliance at different levels, namely in terms of:
- Person Responsible for Regulatory Compliance (PRRC), a role that can only be subcontracted in the case of micro and small enterprises within the meaning of EU Commission’s Recommendation 2003/361/EC. Guidance document MDCG 2019-7 provides answers to the most frequent questions on the PRRC role.
More information is also available in our blog article: The role of a PRRC under the MDR
- Quality Management System (QMS) for medical device manufacturers.
See section Do Class I medical device manufacturers need a certified Quality Management System? below for details.
- Device conformity with the EU MDR’s General Safety and Performance Requirements (GSPR), as proven through documented evidence that must remain available to competent authorities.
See section What documentation does the manufacturer need to CE mark a Class I medical device? below for details.
- Manufacturer and device registrations in the European database for medical devices, EUDAMED, particularly in the Actors Registration module. Although EUDAMED is not yet fully operational, it is recommended to verify the national positions regarding the obligation to register as a manufacturer in EUDAMED.
- Product liability coverage for claims of damage compensation, according to EU MDR Article 10(16), which can be achieved through product liability insurance and needs to be proportionate to the device risk class and type of device.
Guidance document MDCG 2019-15 (Guidance notes for manufacturers of Class I medical devices) provides detailed information on how to implement the requirements. This guidance also applies for importers/distributors who would undertake activities that correspond to “legal manufacturer” obligations, as mentioned in section Is anyone who “just” sells simple medical items a medical device manufacturer?.
Achieving EU MDR compliance for Class I manufacturers who do not have in-house regulatory and quality knowledge is not realistic. Support from experts can accelerate the process and avoid newcomer’s mistakes. See section How can Decomplix help?
However, it is important to understand that, once CE marking is duly completed, compliance maintenance is also labor-intensive and the Class I manufacturer needs qualified and permanent regulatory and quality resources, along with top management understanding of the requirements and commitment to continuous compliance.
What activities can a Class I medical device manufacturer delegate?
Whereas the obligations of the manufacturer cannot be delegated, many activities can be subcontracted to third parties, provided they are fully controlled by the manufacturer via appropriate quality agreements that are contracts describing the respective quality and regulatory duties in detail. At all times, the manufacturer must exert control over the processes that are conducted on its behalf by third parties.
Activities that can and are usually delegated include:
- Clinical investigations, including Post-Market Clinical Follow-up studies, which can be sponsored by third parties under the EU MDR, subcontracted to a healthcare institution.
- Production activities (including packaging) subcontracted to a medical device manufacturer, preferably a company that holds ISO 13485 certification (or at least ISO 9001 certification) for its QMS.
- Warehousing and transportation subcontracted to a logistics provider that has suitable premises for and experience in handling medical devices.
- Labelling translations subcontracted to a translation agency with expertise in medical terminology or to your distributors/importers. Note that if your distributor/importer undertakes the translation on its own, they would be subject to the conditions and requirements in EU MDR Article 16(2), (3) and (4).
- Verification testing conducted at accredited laboratories, e.g. for biocompatibility testing per ISO 10993-1 or electrical safety per IEC 60601-1.
- As already mentioned, the PRRC role can be subcontracted to an external individual or organization but only in the case of manufacturers corresponding to the definition of micro and small companies.
- Other regulatory and quality assurance activities may be delegated to a central entity within a big corporation, e.g. EUDAMED registration, Vigilance report submissions, QMS internal audits.
Before you start delegating any of the above activities, as a manufacturer, you need to evaluate and qualify the subcontractor, according to the requirements in your QMS for supplier control. Critical suppliers are also subject to continuous monitoring, e.g. through periodic audits by the manufacturer.
What about design and development? Caution is recommended. Device control is one of the most important duties of the manufacturer. The manufacturer’s processes relative to risk management, design verification & validation, clinical evaluation, and change management would need to be cascaded down to the processes in place at the subcontractor and to be deployed following the stages in the manufacturer’s design and development process. In practice, this is extremely complex to set up and ends up involving numerous parties (e.g. clinical research organizations, testing labs) that need to be coordinated by both the contract developer and the manufacturer.
A manufacturer could see itself as the “private labeller”, who merely places on the market under its name someone else’s medical device. This does not equate to delegating the device’s design and development. In this case, the supplier of the final device is the “legal manufacturer” and the “private labeller” needs to carefully review what aspects of EU MDR Article 16 apply to its activities. See: Are you a medical device manufacturer under EU MDR if you “only” sell medical items?
What documentation do manufacturers need to CE mark a Class I medical device?
Do not expect the documentation needed for CE marking a medical device to be a one-shot activity; it is not some file you would get from your supplier and you would keep in a folder in case a competent authority may ask for it.
The documentation in support of CE marking is a set of living documents, constantly evolving due to device changes, information gathered in the post-market phase, or regulatory changes. You, as the manufacturer, must keep it up to date and available to competent authorities for 10 years after the last device covered by the EU Declaration of Conformity has been placed on the market.
Before you can sign the EU Declaration of Conformity, which means claiming that your company and the concerned devices fulfill the applicable provisions of the EU MDR, you need to have compiled a Technical Documentation set with the structure and contents described in Annexes II and III of the EU MDR. The Technical Documentation must provide sufficient demonstration of conformity with the applicable General Safety and Performance Requirements (GSPR) set forth in Annex I of the EU MDR.
Three main processes sustain the building blocks of the Technical Documentation, and they are tightly intertwined:
As part of the Technical Documentation for CE-marking, the manufacturer also needs to maintain a list of the Unique Device Identifiers assigned to each device model (UDI-DI) and a Basic UDI-DI (for the generic device group). It is recommended to keep in the same list the core data elements associated with the UDI-DIs, as required in Part C of EU MDR Annex VI, to facilitate their uploading in the European medical device database, EUDAMED.
If you are interested in the specifics of UDI for medical device software, please see: UDI for Medical Device Software (MDSW) under EU MDR.
Once the Technical Documentation is compiled and released, you can sign the EU Declaration of Conformity that must contain, as a minimum, the elements indicated in Annex IV of the EU MDR. If your medical device is subject to other EU legislation that also calls for CE-marking, e.g. Regulation (EU) No. 2016/245 on personal protective equipment (PPE) or Directive 2011/65/EU on the restriction of hazardous substances in electrical/electronic equipment (RoHS) or Directive 2014/53/EU on radio equipment (RED), you should issue a “Single” EU Declaration of Conformity stating compliance with all legislative acts that apply. In such a case, you want to make sure that the documented evidence in support of compliance with those other legislative acts is duly compiled and maintained together with the Technical Documentation under EU MDR.
Last, do not forget to check the mandatory language requirements in the CE-marking countries you are interested in. Medical device CE marking is mandatory in all countries of the European Economic Area (EEA), Turkey, Switzerland, and Northern Ireland. Language requirements are governed by the corresponding national legislation, not by the EU MDR. For example, EU Declarations of Conformity must be issued in a language accepted by the national competent authority, although English is commonly accepted. Conversely, labelling — which includes the product labels and the instructions for use — is almost always required in the national official language(s), particularly if the medical device is intended for layman use.
More information is available from EU MDR language requirements — what manufacturers and distributors need to know.
Do Class I medical device manufacturers need a certified Quality Management System?
Not necessarily. The manufacturer must have established the required processes according to Article 10(2) and 10(9) of the EU MDR, and be in a position to demonstrate their application. The Quality Management System (QMS) is the set of procedures that describe the processes undertaken by the company as well as any templates and completed records to show evidence that such processes are being systematically and correctly followed.
Contrary to the former Directive 93/42/EEC on medical devices (MDD), the QMS requirements in the EU MDR are not lighter for Class I medical device manufacturers. Therefore, Class I medical device manufacturer should have established a QMS that includes procedures describing how the following processes are conducted:
- Risk management for medical devices
- Management responsibility and resource management, including the selection/control of suppliers
- Strategy for regulatory compliance, including the conformity assessment process and change management
- Technical documentation management, including the identification of applicable GSPRs in Annex I of the EU MDR
- Clinical evaluation, aligned with EU MDR Article 61 and Annex XIV, including Post-market clinical follow-up (PMCF)
- Labeling management
- UDI management, following also the requirements in guidance document MDCG 2021-19 on the integration of UDI within the QMS
- Product realization (i.e. device design/development and production), whether conducted in-house or subcontracted
- Post-Market Surveillance (PMS) system and Vigilance reporting (i.e. serious incidents, Field Safety Corrective Actions, and trend reports)
- Process/product monitoring & measurement and product improvement
- Corrective Actions / Preventive Actions (CAPA)
For medical devices, ISO 13485 is the reference standard that sets the requirements of a QMS. However, standards are not mandatory and the manufacturer of Class I medical devices may choose other approaches to achieve compliance with the QMS requirements in the EU MDR. Certification of the manufacturer’s QMS under EN ISO 13485 by a Notified Body is however useful as a first step for EU certification of medical devices that require the involvement of a Notified Body in the conformity assessment process. This is not the case for Class I devices.
See also: Certification of a Quality Management System according to ISO 13485.
Class I medical device conformity Checklist
A regulatory compliance checklist should be part of your Class I medical device CE-marking project plan to avoid missing applicable conformity requirements in your role as manufacturer under the EU MDR. In the checklist, you should also consider the many MDCG guidance documents that are being published to help interpret the EU MDR requirements and that may apply to your processes and devices.
Bear in mind that, in the EU Declaration of Conformity, you must state that it is issued “under the sole responsibility of the manufacturer” and that the device concerned is in conformity with the EU MDR. You want to make sure that this is true.
The below checklist can help you as a basis to verify that the manufacturer’s duties have been duly completed before you start selling. The specifics of your medical device should be added in as much detail as possible for a comprehensive verification.
- Is there a Quality Manual and/or QMS procedures describing ALL relevant processes in EU MDR Article 10(9)?
- Has a PRRC been appointed, per EU MDR Article 15?
- Is there liability insurance or otherwise sufficient financial coverage for product liability, per EU MDR Article 10(16)?
- Have Quality Agreements been established with contract manufacturers or OEMs (i.e. suppliers) and distributors/importers?
- Has the device classification under the rules in EU MDR Annex VIII been duly justified, in alignment with its intended purpose?
- Is there proof of GSPR conformity through compliance with applicable Common Specifications, current versions of relevant standards and/or MDCG guidelines?
- Is the evidence of compliance compiled in a Technical Documentation set aligned with EU MDR Annex II and, for Post-Market Surveillance documentation, per EU MDR Annex III? Does it include a Clinical Evaluation Plan and Clinical Evaluation Report per EU MDR Annex XIV?
- Has the UDI been assigned to the device, per EU MDR Article 27 and Annex VI?
- Has the device labelling been completed, where applicable, and translated into the mandatory languages for the countries of interest?
- Has the EU Declaration of Conformity been signed, in compliance with the structure/contents described in EU MDR Annex IV, and is it available in English or in a language accepted by the competent authorities of the countries of interest?
- Is the manufacturer registered in the Actor Registration module of EUDAMED?
What else do foreign companies selling Class I medical devices in Switzerland need to be aware of?
The non-renewal of the Mutual Recognition Agreement (MRA) between Switzerland and the EU has left medical devices (and in-vitro diagnostic devices) outside the scope of the MRA and, thus, manufacturers based in EEA countries or having a EU Authorized Representative in EEA countries are viewed as manufacturers from third countries.
As a result, even if Switzerland continues to recognize CE marking and no additional conformity assessment is required, a couple additional requirements have been introduced. Since 26 May 2021, medical device manufacturers who are not established in Switzerland need:
- To designate a Swiss Authorised Representative (CH-REP). For Class I devices, a “grace period” until 31 July 2021 applied.
For more details, please see: Swiss Authorised Representatives for Medical Device Manufacturers.
- To ensure its Swiss importers duly comply with the new requirements. Note that the Swiss Importer role is determined “by action” (i.e. any entity that places devices from a foreign company on the Swiss market), not by designation from the manufacturer. And healthcare institutions who receive direct shipments from abroad and are the final users of the devices are not considered to be Swiss importers. Consequently, you need to consider what Swiss companies and organizations you are shipping your devices to.
For more details, please see: Swiss medical device importers – regulatory requirements.
How can Decomplix help?
Decomplix offers consultancy services in all regulatory and quality assurance matters relative to medical devices, with particular focus on the Swiss market and CE marking. We have in-house experts and a network of first-in-class partners.
We can support your company in fulfilling all the requirements of a Class I manufacturer under the EU MDR and ensure compliance in the most efficient manner. If you wish to discuss your needs with us, please contact us for a non-binding CE marking quote.
In addition, we offer Swiss Authorised Representative services under both the MedDO and the IvDO, and already represent numerous foreign manufacturers. Our services include instructions and checklists for your understanding of the applicable requirements. If you are interested in Decomplix’ Swiss Authorised Representative services, please contact us via this form and send us the relevant data mentioned there.
- Is my product a medical device? How to determine if your product requires a CE Mark in the EU?
- The intended purpose – or, what does your medical device do?
- Which MDR requirements apply to distributors of medical devices?
- The role of a PRRC under the MDR
- Post-Market Surveillance – 10 Questions about PMS & MDR
- Swiss Authorised Representatives for Medical Device Manufacturers – Decomplix
- Clinical evaluation of medical devices under the EU MDR – Decomplix
- How the medical device regulation system enhances patient safety