FAQ - medical devices

A medical device means any instrument, apparatus, device, 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:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease;
• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability;
• investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state;
• providing information through the 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, although its function may be assisted by such means.

The following products are also considered medical devices:

• devices for the control or support of conception;
• products specifically intended for the cleaning, disinfection, or sterilization of devices referred to in Article 1(4) and of the devices described above.

See Article 2 of the Medical Device Regulation (MDR).

 

• https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745

https://health.ec.europa.eu/system/files/2023-09/md_borderline_manual_en.pdf

https://health.ec.europa.eu/system/files/2023-06/mdcg_2022-5_en.pdf

MDR stands for Medical Device Regulation (Regulation (EU) 2017/745), including its corrigenda and amendments, which replaced the previous directives: Directive 90/385/EEC on Active Implantable Medical Devices and Directive 93/42/EEC on Medical Devices.

The Medical Device Regulation aims to ensure the safety, quality, and performance of medical devices, as well as to protect the health and rights of patients and users.

An active device is any device whose operation depends on a source of energy other than that generated by the human body for that purpose or by gravity, and which acts by modifying the density of that energy or converting it. Devices intended solely to transmit energy, substances, or other elements between an active device and the patient, without any significant modification, are not considered active devices. Software is also considered an active device.

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745

It is recommended to consult the following documents:

• Classification Rules as set out in Annex VIII of the MDR
• MDCG 2021-24 – “Guidance on Classification of Medical Devices”.
  
  • REGOLAMENTO (UE) 2017/ 745 DEL PARLAMENTO EUROPEO E DEL CONSIGLIO - del 5 aprile 2017 - sui dispositivi medici, che modifica la direttiva 2001/ 83/ CE, il regolamento (CE) n. 178/ 2002 e il regolamento (CE) n. 1223/ 2009 e abroga le direttive 90/ 385/ CEE e 93/ 42/ CEE del Consiglio (europa.eu)

  https://health.ec.europa.eu/document/download/cbb19821-a517-4e13-bf87-fdc6ddd1782e_en?filename=mdcg_2021-24_en.pdf

MDA/MDN codes reflect the design and intended purpose of the device and are therefore primarily relevant for assigning personnel involved in the review of technical documentation. In some specific cases, the Notified Body (NB) may assign product reviewers to assess the product's performance and safety aspects during an audit.

Example 1: A surgical laser for refractive eye surgery is assigned to MDA 0302 Active non-implantable devices using non-ionizing radiation and not to MDA 0309 Active non-implantable ophthalmological devices, because although both codes are specific to the device, MDA 0302 appears higher in the list.

Example 2: An orthopedic surgery screw is assigned to MDN 1102 Non-active osteo- and orthopedic implants and not to MDN 1104 Soft tissue implants and other non-active implants, because MDN 1102 appears higher in the list.

European Medical Device Nomenclature (EMDN)

The European Medical Device Nomenclature (EMDN) is intended to support the functioning of the European Database on Medical Devices (EUDAMED). Among its various uses, it is employed by manufacturers for the registration of medical devices in EUDAMED, where it is associated with each Unique Device Identifier (UDI-DI).

As the EMDN primarily serves regulatory purposes in support of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), it also plays a key role in MDR/IVDR device documentation and technical documentation, technical documentation sampling conducted by Notified Bodies, post-market surveillance, vigilance activities, post-market data analysis, and more.

It is designed to support all stakeholders in carrying out their activities under the MDR and IVDR and provides patients with key descriptions of their devices, as well as information on other devices available on the market and registered in EUDAMED.

For more information:
https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_14_mdr_codes_en_0.pdf
https://webgate.ec.europa.eu/dyna2/emdn/

An economic operator means:

• a manufacturer,
• an authorized representative,
• an importer,
• a distributor, or
• the person referred to in Article 22(1) for systems and procedure packs, and Article 22(3) for any natural or legal person that sterilizes systems or procedure packs.

If you are one of these entities, you are an economic operator.

The difference between the MDD and the MDR is that MDD stands for Medical Device Directive, while MDR stands for Medical Device Regulation. Both are legal frameworks governing the medical device market in the European Union, but they differ in several key aspects:

The MDD is a directive, meaning it consists of rules that each EU Member State must transpose into its national legislation.

The MDR is a regulation, meaning it is directly applicable in all EU countries without the need for national implementing legislation. This ensures a more uniform application of the rules across the EU, improving consistency and transparency of the regulatory framework.

While the MDD consisted of 23 articles and 12 annexes across 60 pages, the MDR includes 123 articles and 17 annexes across 175 pages.

The MDD was adopted in 1993 and was subsequently amended several times. The MDR entered into force in May 2017 and became fully applicable from May 2020, following a three-year transition period. As a result, the MDR replaced the MDD as well as two other directives concerning active implantable medical devices and in vitro diagnostic medical devices.

The MDR introduces several changes and improvements compared with the MDD, including:

• Expanded definition of medical devices: The MDR broadens the definition of medical devices to clearly include products intended for the cleaning, disinfection, or sterilization of devices.

• Increased clinical evidence requirements: The MDR requires more robust and extensive clinical data to demonstrate the safety and performance of medical devices, particularly high-risk devices. It also establishes a new consultation procedure for the clinical evaluation of certain high-risk devices.

• Strengthened post-market surveillance and vigilance: The MDR enhances the obligations of manufacturers, importers, distributors, and Notified Bodies to monitor the quality, safety, and performance of medical devices throughout their lifecycle. It also introduces new reporting requirements and timelines for incidents and field safety corrective actions.

• Improved traceability and transparency: The MDR establishes a new Unique Device Identification (UDI) system for all medical devices, facilitating identification and traceability throughout the supply chain. It also introduces EUDAMED, a new EU database that stores and provides public access to information on medical devices, including UDI data, certificates, clinical investigations, incidents, recalls, and more.

The new Regulation is four times longer than its predecessor, the Medical Device Directive (MDD), and contains five additional annexes.

The word “safety” appears 290 times in the MDR, compared with only 40 times in the MDD.

Significant changes in the wording used in the new legislation will require companies to streamline their portfolios and carry out a comprehensive impact assessment to implement the necessary changes and remain compliant.

Annex I, General Safety and Performance Requirements (GSPRs), identifies new conditions that will need to be addressed for most existing devices (CE-marked under the MDD). Existing products must be recertified in accordance with the new requirements.

The new requirements will oblige most companies to update their clinical data, technical documentation, and labeling.

Unique Device Identification (UDI) will be implemented to help track devices throughout the economic operator’s supply chain and will be required on all labels.

While the scope of the MDD did not include non-medical devices and AIMDs (Active Implantable Medical Devices), both are covered by the MDR.

The definition of a medical device will be expanded to include certain previously unregulated non-medical and cosmetic products. Examples include non-corrective contact lenses, liposuction equipment, and laser hair removal devices.

Manufacturers will be required to generate and provide more extensive clinical data to demonstrate safety and claimed performance, including more stringent equivalence requirements.

Manufacturers will be required to report all incidents, injuries, and deaths through an EU portal that centralizes relevant data, allowing patients greater access to safety information. The reporting timeframe for incidents that do not result in death or serious deterioration of health has been reduced from 30 days to 15 days.

Companies transitioning to the MDR will need to review core processes, including quality assurance, risk management, and post-market activities. These processes will require careful review, planning, and updating to ensure compliance with the new requirements.

Many medical devices will be reclassified into higher risk classes, and a new classification has been introduced for reusable surgical instruments, which require oversight by a Notified Body.

Manufacturers of legacy devices intending to transition to the MDR and holding directive certificates issued on or after 25 May 2017, which were still valid on 26 May 2021 and expired before 20 March 2023, may continue to place legacy devices on the market and benefit from the extended transition period until 26 May 2024, provided that one of the following conditions is met:

• The manufacturer signed a formal written agreement with a Notified Body under the Regulation before the expiry of the directive certificates; OR
• A derogation/exemption was granted by a Competent Authority under Article 59(1) or Article 97(1) of the MDR before 20 March 2023.

In addition, manufacturers may benefit from the extended validity of directive certificates for legacy devices if the following conditions are met:

• By 26 May 2024, manufacturers have implemented an MDR-compliant quality management system and submitted a formal application to a Notified Body for MDR conformity assessment.
• By 26 September 2024, a formal agreement has been signed with a Notified Body for the device covered by the expired certificate, and appropriate surveillance of the legacy devices is ensured.

Extension of the transition period

This provision amends Article 120(3) of the MDR.

• The transition period is extended from 26 May 2024 to 31 December 2027 for higher-risk devices (Class III implantable devices and Class IIb devices, except for certain devices for which the MDR provides exemptions, as these devices are based on well-established technologies).

• And until 31 December 2028 for medium- and lower-risk devices (other Class IIb devices and Class IIa, Im, Is, and Ir devices).

• The amendment also introduces a transition period until 26 May 2026 for custom-made Class III implantable devices, which are currently not covered by Article 120(3) MDR. While manufacturers of custom-made Class III implantable devices have been required to comply with all applicable MDR requirements since 26 May 2021, they will now have additional time to obtain certification of their quality management system by a Notified Body. Here too, the transition period applies only if the manufacturer submitted an application before 26 May 2024 and signed a contract with the Notified Body before 26 September 2024.

As with the current Article 120(3) MDR, the extended transition period applies only to “legacy devices”, namely devices covered by a certificate or declaration of conformity issued under Council Directives 90/385/EEC or 93/42/EEC before 26 May 2021.

In addition, application of the extended transition period is subject to several cumulative conditions:

• The devices must continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable.

• The devices must not undergo significant changes in design or intended purpose.

• The devices must not present an unacceptable risk to the health or safety of patients, users, other persons, or to other aspects of public health protection.

• By 26 May 2024, the manufacturer must have implemented a Quality Management System (QMS) in accordance with Article 10(9) of the MDR. This condition is intended to ensure that manufacturers progressively move toward full compliance with MDR requirements. At this stage, no specific attestation is required, meaning no self-declaration or verification of QMS adequacy by a Notified Body is necessary. However, by submitting an application for conformity assessment to a Notified Body (see the next condition), the manufacturer implicitly confirms that its QMS complies with the MDR.

• By 26 May 2024, the manufacturer, or its authorized representative, must have submitted a formal application, in accordance with Annex VII, Section 4.3 of the MDR, for the conformity assessment of a legacy device covered by a directive certificate or declaration of conformity, or of a device intended to replace that device under the MDR.

• By 26 September 2024, the Notified Body and the manufacturer must have signed a written agreement, in accordance with Annex VII, Section 4.3 of the MDR. This condition is intended to ensure that only devices that the manufacturer genuinely intends to transition to the MDR benefit from the extended transition period.

The extension applies to “legacy devices”, meaning devices covered by a certificate or a declaration of conformity issued under Directives 90/385/EEC (Active Implantable Medical Devices) or 93/42/EEC (Medical Devices) before 26 May 2021.

Legacy devices covered by a certificate issued under the AIMDD or the MDD remain subject to appropriate surveillance by the Notified Body that issued the certificate. Alternatively, the manufacturer may agree with a Notified Body designated under the MDR that this body will become responsible for the surveillance.

No later than the date on which the written agreement for MDR conformity assessment must be signed between the manufacturer and the Notified Body, that Notified Body will automatically become responsible for the appropriate surveillance.

The MDR was introduced without grandfathering provisions, meaning that all medical devices CE marked under the Directives must undergo a new certification process under the Regulation because of all the changes it introduces (as explained above). In addition, Notified Bodies themselves were required to apply for MDR designation; a simple “renewal” was not accepted for them either.

Before a medical device can be placed on the market in the European Economic Area (EEA), it must obtain the CE Mark. The CE marking indicates that the legal manufacturer has assessed the device and determined that it meets the General Safety and Performance Requirements of MDR 2017/745.

It is necessary to determine whether the product must be assessed by a Notified Body. This information can be found in the legislation applicable to your product. If the involvement of a Notified Body is required, the CE marking must be accompanied by the Notified Body identification number. The CE mark and the identification number may be affixed separately, provided that they appear clearly linked to one another.

You can use the NANDO database to search for a Notified Body that can certify your product. https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies

The importance of understanding the full range of responsibilities of medical device manufacturers under the MDR.

Article 10 of the MDR sets out the general requirements for all medical device manufacturers and other economic operators under the MDR.

Article 10 requires all manufacturers to:

• Ensure that their medical devices are designed and manufactured in compliance with the MDR.
• Have a risk management system in accordance with Annex I, Section 3 of the MDR.
• Conduct a clinical evaluation for all their devices.
• Maintain up-to-date technical documentation.
• Have access to a Person Responsible for Regulatory Compliance (PRRC).
• Have a Quality Management System (QMS) in place.

Understanding the EU MDR

If compliance with the MDR has been successfully demonstrated following an appropriate conformity assessment (including the involvement of a Notified Body, where required), manufacturers must affix the CE Mark to their devices and comply with the requirements for the use of a Unique Device Identification (UDI) system. They must also ensure that procedures are in place to guarantee that device production continues to comply with the MDR as it evolves, and declare any relevant changes to regulatory authorities in accordance with the contractual agreement with the Notified Body.

Great Britain and Switzerland have their own medical device legislation.

GB: The amended Medical Devices Regulations (UK MDR 2002) extends the recognition of CE-marked medical devices on the Great Britain market. The Medicines and Healthcare products Regulatory Agency (MHRA) also provides clarification on the deadlines for placing CE-marked medical devices and IVDs on the GB market. The applicable timeline depends on the device classification under the relevant Directive or Regulation.

• Class I devices compliant with the EU MDR, or Class A devices compliant with the EU IVDR, may be placed on the GB market until 30 June 2030.
• Class IIb devices may rely on an extended MDD CE certificate in Great Britain until 30 June 2028 (where the EU extension conditions apply) and until 30 June 2030 if covered by a valid MDR CE certificate.
• Class III devices may be placed on the GB market until 31 December 2027 using their MDD CE certificate (where the EU extension conditions apply), or until 30 June 2030 if covered by a valid MDR CE certificate.

Northern Ireland continues to follow EU medical device legislation, and CE marking is required for devices placed on the Northern Ireland market.

Switzerland: Switzerland has recently updated its medical device regulations to align with the new EU Medical Device Regulation (MDR). The Medical Devices Ordinance (MedDO) has been completely revised, and supplementary provisions have been added to the medical device implementing regulations. These new requirements entered into force on 26 May 2021. The Swiss authorities (Swissmedic) accept devices that comply with the EU MDR and have obtained CE marking.

Yes, if you wish to continue selling your devices in Europe, the Single Market, and Türkiye (the United Kingdom and Switzerland follow specific rules). Otherwise, you will no longer be permitted to market them after the expiry date of your current certificate.

A Notified Body is an organization designated by a European Competent Authority to assess the conformity of certain products before they are placed on the market.

These bodies carry out tasks related to the conformity assessment procedures established by the applicable legislation whenever the involvement of an independent third party is required.

Kiwa Medical has the following Notified Bodies under the MDR:

• Kiwa Cermet Italia (KCI) (NB 0476)
• Kiwa Assurance BV, Netherlands (NB 1912)
• For Directive 93/42/EEC, also through KCI's subsidiary Kiwa Belgelendirme Hizmetleri (NB 1984)

The process of qualifying local assessors is underway; however, it will take time for the Notified Bodies (NBs) to qualify local evaluators.

For some countries, this may not be pursued due to labor costs.

Medical device economic operators must have their technical documentation in English, and, if necessary, they may pay for a translator from among our assessors to support the evaluation process (for assessments in another EU country, where English is commonly used).

Please note that all technical documentation must be in English.

No less than 12 months from the time Kiwa Medical receives the technical documentation.

(According to the recent EU Notified Bodies survey on certifications and applications (MDR/IVDR), 25 October 2023: 45% of Notified Bodies reported a waiting time of 6 to 12 months for the issuance of an MDR Quality Management System (QMS) certificate. 40% of Notified Bodies reported a waiting time of 13 to 18 months for the issuance of MDR QMS and product certificates. Waiting times are expected to increase as the new regulatory deadlines approach.)

The costs will be detailed in our quotations, and our fee schedules are publicly available on the websites of the Notified Bodies (NoBos).

If the change is considered substantial, you must contact your Notified Body (NB) and manage the change in accordance with its instructions.

It is not possible. As a Notified Body (NoBo), we can only assess technical documentation within the scope of a signed agreement.

Within the framework of such an agreement, we can perform a Gap Analysis.

Article 15 of the MDR states that every manufacturer must have access to a PRRC (Person Responsible for Regulatory Compliance) who is responsible for regulatory affairs within the company and must be empowered to carry out their duties without prejudice, even where those duties may result in actions that are commercially disadvantageous to the company (for example, requesting the withdrawal of a device from the market for safety reasons).

Most companies will need to employ their own designated responsible person.

However, the MDR provides exceptions for small manufacturers, which do not need to directly employ such a person, provided that they have one permanently and continuously at their disposal.