What is EU MDR. Top 10 Questions Answered.
The European Medical Device Regulation has triggered a tsunami in the medical device industry. All parties involved, from manufacturers over Notified Bodies as well as the European instances have been affected. Today, in 2024, the dust still hasn't settled completely and there are still quite some unclarities related to this topic. In this article we'll give our answer some of the most asked questions.
What is EU MDR?
EU 2017/745 is the official reference of the European Medical Device Regulation (EU MDR). This is the European law that regulates medical devices that are being put on the market in the European Economic Area. This law supersedes the previous European Medical Device Directive (93/42/EEC).
A key difference is that the MDR is a regulation compared to the MDD which was a directive. This means that now, there is no translation from the European text into national laws anymore. The MDR applies as such in all European countries.
The MDR also introduced many new requirements for the medical device industry. If you want to read more about the differences between the MDR and the MDD, you can read our previous article on this topic.
When is/was the EU MDR implementation deadline?
Originally, the EU MDR came into effect in 2017 with a transition time of 3 years. This turned out to be too ambitious and so deadlines have been postponed.
This is the current situation at the time of writing:
The MDR is applicable since May 26th, 2021. This means that all NEW devices that are being put on the EU market need to be CE marked under the MDR.
For legacy devices (devices that were already on the market under the MDD):
For class III devices, the deadline to transition to the MDR has been postponed till December 2027
For class IIa and IIb devices, the deadline to transition to the MDR has been postponed till December 2028
However, some parts of the MDR will be applicable sooner, such as registration in the EUDAMED database. It's important to keep monitoring the press releases related to any changes in this respect as the European Commission might submit new proposals to ensure a continuous supply of medical devices.
How does EU MDR classify medical devices?
Classification rules can be found in Annex VIII of the MDR. MDCG 2021-24 provides further guidance on how to interpret these classification rules.
The principle behind medical device classification did not change from MDD to MDR. It is still based on the risks involved in the use of the devices and it still goes from Class I till Class III. However, as the scope of the medical device definition has been updated and some of the classification rules have changed, it's important to verify if your device is still under the same classification.
To make it easier where the MDR deviates from the MDD in terms of classification rules, you can check our comparison:
| Rule | MDD 93/42/EEC | MDR EU 2017/745 | Remarks |
|---|---|---|---|
| 1 | All non-invasive devices are in Class I, unless one of the rules set out hereinafter applies. | All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies. | |
| 2 | All non-invasive devices intended for channelling or storing blood, body liquids or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in Class IIa: — if they may be connected to an active medical device in Class IIa or a higher class, — if they are intended for use for storing or channelling blood or other body liquids or for storing organs, parts of organs or body tissues, in all other cases they are in Class I. | All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa: – if they may be connected to a class IIa, class IIb or class III active device; or – if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb. In all other cases such devices are classified as class I. | |
| 3 | All non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids or other liquids intended for infusion into the body are in Class IIb, unless the treatment consists of filtration, centrifugation or exchanges of gas, heat, in which case they are in Class IIa. | All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa. All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III. | |
| 4 | All non-invasive devices which come into contact with injured skin: — are in Class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates, — are in Class IIb if they are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent, — are in Class IIa in all other cases, including devices principally intended to manage the micro-environment of a wound. | All non-invasive devices which come into contact with injured skin or mucous membrane are classified as: – class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates; – class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent; – class IIa if they are principally intended to manage the micro-environment of injured skin or mucous membrane; and – class IIa in all other cases. This rule applies also to the invasive devices that come into contact with injured mucous membrane. | |
| 5 | All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I: ◄ — are in Class I if they are intended for transient use, — are in Class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity, in which case they are in Class I, — are in Class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are in Class IIa. All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to an active medical device in Class IIa or a higher class, are in Class IIa. | All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class I active device are classified as: – class I if they are intended for transient use; – class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity, in which case they are classified as class I; and – class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are classified as class IIa. All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to a class IIa, class IIb or class III active device, are classified as class IIa. | |
| 6 | All surgically invasive devices intended for transient use are in Class IIa unless they are: — intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III, — reusable surgical instruments, in which case they are in Class I, — intended specifically for use in direct contact with the central nervous system, in which case they are in Class III, — intended to supply energy in the form of ionising radiation in which case they are in Class IIb, — intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class IIb, — intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are in Class IIb. | All surgically invasive devices intended for transient use are classified as class IIa unless they: – are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III; – are reusable surgical instruments, in which case they are classified as class I; – are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III; – are intended to supply energy in the form of ionising radiation in which case they are classified as class IIb; – have a biological effect or are wholly or mainly absorbed in which case they are classified as class IIb; or – are intended to administer medicinal products by means of a delivery system, if such administration of a medicinal product is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are classified as class IIb. | |
| 7 | All surgically invasive devices intended for short-term use are in Class IIa unless they are intended: — either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III, — or specifically for use in direct contact with the central nervous system, in which case they are in Class III, — or to supply energy in the form of ionizing radiation in which case they are in Class IIb, — or to have a biological effect or to be wholly or mainly absorbed in which case they are in Class III, — or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class IIb. | All surgically invasive devices intended for short-term use are classified as class IIa unless they: – are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III; – are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III; – are intended to supply energy in the form of ionizing radiation in which case they are classified as class IIb; – have a biological effect or are wholly or mainly absorbed in which case they are classified as class III; – are intended to undergo chemical change in the body in which case they are classified as class IIb, except if the devices are placed in the teeth; or – are intended to administer medicines, in which case they are classified as class IIb | |
| 8 | All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended: — to be placed in the teeth, in which case they are in Class IIa, — to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are in Class III, — to have a biological effect or to be wholly or mainly absorbed, in which case they are in Class III, — or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class III. | All implantable devices and long-term surgically invasive devices are classified as class IIb unless they: – are intended to be placed in the teeth, in which case they are classified as class IIa; – are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are classified as class III; – have a biological effect or are wholly or mainly absorbed, in which case they are classified as class III; – are intended to undergo chemical change in the body in which case they are classified as class III, except if the devices are placed in the teeth; – are intended to administer medicinal products, in which case they are classified as class III; are active implantable devices or their accessories, in which cases they are classified as class III; – are breast implants or surgical meshes, in which cases they are classified as class III; – are total or partial joint replacements, in which case they are classified as class III, with the exception of ancillary components such as screws, wedges, plates and instruments; or – are spinal disc replacement implants or are implantable devices that come into contact with the spinal column, in which case they are classified as class III with the exception of components such as screws, wedges, plates and instruments. | |
| 9 | All active therapeutic devices intended to administer or exchange energy are in Class IIa unless their characteristics are such that they may administer or exchange energy to or from the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are in Class IIb. All active devices intended to control or monitor the performance of active therapeutic devices in Class IIb, or intended directly to influence the performance of such devices are in Class IIb. | All active therapeutic devices intended to administer or exchange energy are classified as class IIa unless their characteristics are such that they may administer energy to or exchange energy with the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are classified as class IIb. All active devices intended to control or monitor the performance of active therapeutic class IIb devices, or intended directly to influence the performance of such devices are classified as class IIb. All active devices intended to emit ionizing radiation for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb. All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable devices are classified as class III. | |
| 10 | Active devices intended for diagnosis are in Class IIa: — if they are intended to supply energy which will be absorbed by the human body, except for devices used to illuminate the patient's body, in the visible spectrum, — if they are intended to image in vivo distribution of radiopharmaceuticals, — if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of CNS in which case they are in Class IIb. Active devices intended to emit ionizing radiation and intended for diagnostic and therapeutic interventional radiology including devices which control or monitor such devices, or which directly influence their performance, are in Class IIb. | Active devices intended for diagnosis and monitoring are classified as class IIa: – if they are intended to supply energy which will be absorbed by the human body, except for devices intended to illuminate the patient's body, in the visible spectrum, in which case they are classified as class I; – if they are intended to image in vivo distribution of radiopharmaceuticals; or – if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system, or they are intended for diagnosis in clinical situations where the patient is in immediate danger, in which cases they are classified as class IIb. Active devices intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology, including interventional radiology devices and devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb. | |
| 11 | Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause: – death or an irreversible deterioration of a person's state of health, in which case it is in class III; or – a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb. Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb. All other software are classified as class I. | As of Rule 11, the MDD and MDR do not follow the same numbering. In the MDR Rule 11 is specifically concerning software. Rule 11 of the MDD is similar to Rule 12 of the MDR. Therefore you will see rule numbering as follows xx/yy where xx is the rule in the MDD and yy is the rule in the MDR. This has been done to allow easy comparison | |
| 11/12 | All active devices intended to administer and/or remove medicines, body liquids or other substances to or from the body are in Class IIa, unless this is done in a manner: — that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are in Class IIb. | All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body are classified as class IIa, unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are classified as class IIb. | |
| 12/13 | All other active devices are in Class I. | All other active devices are classified as class I. | |
| 13/14 | All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in Article 1 of Directive 2001/83/EC, and which is liable to act on the human body with action ancillary to that of the devices, are in Class III. All devices incorporating, as an integral part, a human blood derivative are in Class III. | All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the devices, are classified as class III. | |
| 14/15 | All devices used for contraception or the prevention of the transmission of sexually transmitted diseases are in Class IIb, unless they are implantable or long term invasive devices, in which case they are in Class III. | All devices used for contraception or prevention of the transmission of sexually transmitted diseases are classified as class IIb, unless they are implantable or long term invasive devices, in which case they are classified as class III. | |
| 15/16 | All devices intended specifically to be used for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses are in Class IIb. All devices intended specifically to be used for disinfecting medical devices are in Class IIa. Unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb. This rule does not apply to products that are intended to clean medical devices other than contact lenses by means of physical action. | All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses are classified as class IIb. All devices intended specifically to be used for disinfecting or sterilising medical devices are classified as class IIa, unless they are disinfecting solutions or washer-disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are classified as class IIb. This rule does not apply to devices that are intended to clean devices other than contact lenses by means of physical action only. | All products that are intended to clean medical devices are now within scope of the MDR (see adapted definition of medical device) |
| 16/17 | Devices specifically intended for recording of X-ray diagnostic images are in Class IIa | Devices specifically intended for recording of diagnostic images generated by X-ray radiation are classified as class IIa. | |
| 17/18 | All devices manufactured utilizing animal tissues or derivatives rendered non-viable are Class III except where such devices are intended to come into contact with intact skin only. | All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable, are classified as class III, unless such devices are manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable and are devices intended to come into contact with intact skin only. | |
| 18 (MDD only) | By derogation from other rules, blood bags are in Class IIb. | This is incorporated in rule 2 of the MDR | |
| 19 (MDR only) | All devices incorporating or consisting of nanomaterial are classified as: – class III if they present a high or medium potential for internal exposure; – class IIb if they present a low potential for internal exposure; and – class IIa if they present a negligible potential for internal exposure. | All following rules are new to the MDR | |
| 20 | All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation are classified as class IIa, unless their mode of action has an essential impact on the efficacy and safety of the administered medicinal product or they are intended to treat life-threatening conditions, in which case they are classified as class IIb. | ||
| 21 | Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified as: – class III if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose; – class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body; – class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities; and – class IIb in all other cases. | ||
| 22 | Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators, are classified as class III. |
What are the new requirements for clinical evaluation and post-market surveillance (PMS)?
The requirements for clinical evaluation and post-market surveillance have been extended in the MDR compared to the MDD.
Clinical evaluation is an activity that is part of the entire lifecycle of a medical device. In the premarket phase, it starts with the identification and generation of clinical safety and performance data. This is also the moment where you identify what is needed in terms of clinical investigations, and as well which questions will need to be answered in these clinical investigations.
The clinical evaluation, including the clinical data gathered, will be part of the technical documentation for CE marking. This clinical evidence will demonstrate the conformity of the device with the relevant safety and performance requirements.
Once the product is on the market, the clinical evaluation continues. The clinical evaluation report will need to be updated, based on the data available from the market, your active and passive post-market surveillance efforts, post-market clinical follow-up (PMCF), literature review, etc.
Clinical evaluation and post-market surveillance are controlled processes within the organization. They are guided by and documented with specific plans and reports. There are many guidance documents related to this topic. Some key guidance documents are:
MDCG 2019-9: Summary of safety and clinical performance
MDCG 2020-5: Guidance on clinical evaluation – Equivalence
MDCG 2020-6: Guidance on sufficient clinical evidence for legacy devices
MDCG 2020-13: Clinical evaluation assessment report template
Note: all MDCG guidances can be found here.
What are the implications for Notified Bodies under EU MDR?
The transition from the MDD to the MDR does not only affect manufacturers of medical devices. It most definitely also affects the Notified Bodies.
All Notified Bodies that want to continue issuing CE certificates under the MDR need to be accredited for it. That means that they need to undergo an assessment themselves where they are being evaluated for their conformity against MDR requirements and their capabilities to perform assessments for MDR compliance. Also for them, there are quite a lot of MDCG guidance documents available.
How does EU MDR impact manufacturers outside the EU?
MDR affects manufacturers outside the EU in the same way as it does manufacturers that are located within the EU. Having an Authorized Representative was already an obligation under the MDD and still is under the MDR.
When manufacturers want to bring new products on the EU market or want to continue to market current devices, they will have to comply with the MDR instead of the MDD, including all requirements stipulated in the MDR. The MDR does add more responsibilities to the different economic operators, including manufacturers, authorized representatives, importers and distributors. These will all have to be taken into account. The European Commission summarized the main responsibilities for manufacturers in this factsheet.
With the introduction of the MDR, there is a specific situation for Swiss manufacturers. The mutual recognition agreement between the EU and Switzerland has not been renewed with regards to the Medical Device Regulation. Consequently, Switzerland is considered to be an EU third country when it comes to medical devices, meaning that Swiss manufacturers need to have an EU authorized representative in Europe to bring their devices to the market. Switzerland has established its own medical device legislation as well, requiring a Swiss Authorized Representative based in Switzerland for all manufacturers that want to bring medical devices on the Swiss market.
What are Unique Device Identifiers (UDIs) and how are they implemented?
Unique device identification or UDI is a unique numeric or alphanumeric code, linked to a medical device. It's established to allow a better identification and traceability of devices on the market. UDI consists of two components:
UDI-DI: a device identifier
UDI-PI: a production identifier
Together they provide a lot of useful information about each device and facilitates recalls, helps the fight against counterfeiting and improves patient safety.
The UDI does not replace any existing labelling requirement though, it's an additional requirement
What are the requirements for technical documentation and conformity assessment?
Technical documentation requirements are described in Annexes II and III of the MDR. The requirements itself depend on the risk classification of the device. The minimum content but as well the structure is defined by these annexes.
The classification of the device needs to be explained and justified in the Technical Documentation.
The General Safety and Performance Requirements (GSPRs) set the baseline. In the technical documentation, manufacturers have to provide objective evidence to demonstrate they comply to the relevant GSPR.
As the MDR integrated the use of UDIs, this needs to be demonstrated in the Technical Documentation as well. The UDI also ahs a direct effect on the labelling, artwork and Declaration of Conformity, all mandatory sections of the Technical Documentation.
Not only the current version of the device needs to be described. Also an overview of previous generations as well as similar devices need to be listed.
Design stages and procedures that apply to the devices need to be described for all device classes, as well as post-market surveillance data and clinical evaluation results.
Conformity assessment is done by competent authorities for class I devices and by Notified bodies for class Im, Is, Ir, IIa, IIb and III.
How does EU MDR impact software and digital health products?
Software as or in a medical device (SaMD or SiMD, together SxMD) have received their own space in the MDR. Even though software products were already included in the MDD, they are much more prominent in the MDR. Referring to the section above about the classification rules, software has received its own classification rule (rule 11).
In order to know whether a software device is within scope of the MDR, there is this useful infographic together with the MDCG 2019-11 guidance document:
Software is most of the time also not isolated. The MDR addresses the risk of interaction of software with other medical devices as well as cybersecurity risks in several places in the legislative text.
Some important guidances are:
MDCG 2019-16: Guidance on cybersecurity for medical devices
MDCG 2023-4: Guidance on MDSW intended to work in combination with hardware or hardware components
MDCG 2020-1: Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
What are the implications of Brexit on EU MDR?
In 2020, the UK decided to leave the European Union, having a considerable impact on the medical device industry. As the UK is no longer part of the European Economic Area, it is considered to be a EU third country.
This means that British manufacturers need to have an EU Authorized Representative when they want to put medical devices into the EU market. They will have to comply with all requirements of the MDR as such.
For European manufacturers wanting to bring medical devices to the UK market, things have changed as well. Following the Brexit, the UK has established its own specific regulations as well. The UK's regulatory framework is similar to the European one, focusing on ensuring patient safety. It requires technical documentation to obtain approval to put devices to the market and later on requires the submission of post-market surveillance reports.
In the UK, it's the Medecines and Healthcare Products Regulatory Agency (MHRA) that regulates all types of medical devices, in-vitro diagnostics, procedural devices and custom-made devices. There is no separate regulation for IVDs as opposed to Europe's IVDR. In order to place devices on the UK market, they need to obtain UKCA marking and be registered with the MHRA.
There is still a grace period when it comes to CE marked devices on the UK market:
A valid CE mark is a CE marking that enables the medical device to be placed on the EU market. The Government has introduced measures which provide that CE marked medical devices may be placed on the UK market to the following timelines:
General medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028
In vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (IVDD) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030, and
General medical devices including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until 30 June 2030.
Key Take-Aways
The MDR has brought many challenges to the medical device industry and continues to create confusion sometimes. Whether you want to bring a new device to the EU market or transition from an existing certificate to an MDR CE certificate, there are a few main things you need to pay attention to:
Is my device within scope of the MDR and what is the classification of my device under the MDR?
Make a gap analysis between the MDR requirements and your current documentation and QMS
Ensure that your Notified Body is accredited to issue certificates for your specific device under the MDR
Ensuring that you have clear documentation and a well-established QMS are key factors for compliance under the MDR. If you want to learn more on how Matrix Requirements can help you with that, don't hesitate to book a demo.