Last updated on 18 March 2024
See history of updates below.
This post is an attempt to provide an information resource for the Medical Devices Regulation (EU) 2017/745 (MDR). The information provided is by no means exhaustive or complete. Although the focus of this post is the MDR, the The IVDR is mentioned occasionally.
Click on the ‘+’ sign next to each heading to access the information under the heading.
| Date | Update(s) |
|---|---|
| 18 Mar 2024 | Under the section Commission Implementing regulations or decisions, added information on Commission Implementing Decision (EU) 2024/815 of 6 March 2024. |
| 21 Dec 2023 | New section Is there a comprehensive Q&A available for applicants, MA holders of medicinal products and notified bodies with respect to the implementation of the MDR and IVDR? added |
| 19 July 2023 | New section added entitled Regulation (EU) 2023/607 amending the MDR and the IVDR as regards the transitional provisions for certain medical devices and IVDs published added. |
| 7 Jul 2023 | Table in section Commission Implementing regulations or decisions updated to add information on Commission Implementing Decision (EU) 2023/1410 of 4 July 2023. |
| 21 June 2023 | Section entitled Commission Implementing regulations or decisions updated to add information on and link to Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023 |
| 24 Jan 2023 | Section entitled About expert panels and the clinical evaluation consultation procedure (CECP) for certain Class III implantable devices and Class IIb devices updated to add a link to the document Annual overview of devices subject to the clinical evaluation consultation procedure pursuant to Article 54(4) of Regulation (EU) 2017/745 on medical devices (April 2021- June 2022) |
Essentially, three Medical Device Directives have been replaced with two Medical Device Regulations as shown in the table below:
| Directive(s) | Replacing Regulation | Further information |
|---|---|---|
| 1) The Medical devices Directive 93/42/EEC (MDD) 2) The Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) | The Medical Devices Regulation (EU) 2017/745 (MDR) replaces the MDD and the AIMDD. | The MDR came into force1 on 26 May 2017 and became applicable2 on 26 May 2021 as per amending Regulation (EU) 2020/561. |
| The In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD) | The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) replaces the IVDD. | The IVDR came into force on 26 May 2017 and became applicable on 26 May 2022. In December 2021, the European Parliament and Council adopted an amendment to the IVDR, which defers the dates of application for certain in vitro diagnostic medical devices (IVDs). This amendment allows for a more progressive roll-out of requirements and aims to prevent potential disruption to supply of essential IVDs, due to the shortage in notified body capacity More information is available here. |
EU Regulations, Directives etc. are published in the Official Journal Of the EU (OJEU) before they enter into force and become applicable.
1 Entry into force
Represents the date when an EU regulation has legal existence in the EU legal order and in the national legal order of each Member State. Sometimes the date of entry into force is also the date of applicability of a regulation, meaning that a regulation is applicable from the date when it enters into force.
2 Becoming applicable
It is common practice for the legislator to establish two different dates under the article on entry into force. One date establishes the legal existence of the act (entry into force); the second date establishes the date when it becomes applicable (applicability).
Version 2 – December 2022 of the above manual has been published and you can download it here.
The aspects concerning the borderline between medical devices and other types of products, also known as qualification of a product, are generally governed by Article 4 Regulatory status of products of the MDR and the corresponding Article 3 of the IVDR.
Borderline cases are those for which it is not clear from the outset whether a given product is a medical device, or an in vitro diagnostic medical device (IVD), or not.
Various paragraphs under Article 1 Subject matter and scope of both Regulations are also relevant. They exclude certain types of products from the scope of the Regulations. Where a given product does not fall within the definition of medical device or is excluded from their scope, other EU or national legislation may be applicable. This Manual will however not provide indications to that effect.
The Manual should be read in conjunction with other documents providing guidance on
borderline, such as
- MDCG 2022-5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices and
- MDCG 2019-11 Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746
The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices. This approach uses a set of criteria that can be combined in various ways in order to determine classification, e.g.
- duration of contact with the body,
- degree of invasiveness,
- local vs. systemic effect,
- potential toxicity,
- the part of the body affected by the use of the device and
- if the device depends on a source of energy.
The criteria can then be applied to a vast range of different medical devices and technologies. These are referred to as the ‘classification rules’ and are set out in Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR).
As stated in Article 51 of the MDR, Devices shall be divided into the following classes, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII of the regulation:
- Class I
- Class IIa
- Class IIb
- Class III
In addition, according to Article 52(7)(a),(b) and (c), Class I devices can be further subdivided into:
- Is – sterile condition,
- Im – measuring function and
- Ir – reusable surgical.
The technical documentation to be drawn up by the manufacturer must include the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII of the MDR.
You can find further information on the classification of medical devices, in the MDCG document MDCG 2021-24 Guidance on classification of medical devices.
What is a notified body?
‘Notified body’ means a conformity assessment body designated in accordance with this Regulation (Art. 2 (42)) (by an EU country) to assess the conformity of medical devices before being placed on the market.
What do notified bodies do?
These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required. The European Commission publishes a list of such notified bodies.
Notified bodies offer conformity assessment services to manufacturers in an area of public interest. It is the responsibility of the EU country to notify conformity assessment bodies within their jurisdiction according to principles laid down in Decision 768/2008/EC Notified bodies.
List of notified bodies
The European Commission strives to maintain an up-to-date list of bodies notified by EU countries and make the necessary information available to all interested parties. Lists of Notified Bodies are on the NANDO website (New Approach Notified and Designated Organisations). The lists:
- include the identification number of each notified body
- include the tasks for which it has been notified
- are regularly updated
What is conformity assessment?
‘Conformity assessment’ means the process demonstrating whether the requirements of the MDR relating to a device have been fulfilled. (Art 2. (40)).
- A product undergoes a conformity assessment before it is placed on the market
- It includes testing, inspection and certification
- The applicable product legislation specifies the procedure for each product
What are the objectives of the conformity assessment procedure?
- To demonstrate that a product being placed on the market complies with all relevant regulatory requirements.
Why is conformity assessment necessary?
The conformity assessment procedure instils confidence in consumers, public authorities and manufacturers regarding the conformity of medical devices.
A manufacturer can only place a product on the EU market when it meets all the applicable requirements. The conformity assessment procedure is carried out before a product can be sold. The European Commission’s main objective is to help ensure that unsafe or otherwise non-compliant products do not find their way onto the EU market.
Declaration of conformity
As part of conformity assessment, the manufacturer must draw up a declaration of conformity (DoC).
The EU declaration of conformity shall state that the requirements specified in the MDR have been fulfilled in relation to the device that is covered. The manufacturer shall continuously update the EU declaration of conformity (Art. 19).
- The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV of the MDR and
- shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available (Art. 19)
By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance with the requirements of this Regulation and all other Union legislation applicable to the device (Art. 19).
Source: European commission; Medical Devices Regulation (EU) 2017/745
Just as compliance with the ‘Essential Requirements (ERs)’ was key to establishing conformity with the Medical Device Directive (MDD, 93/42/EEC) and Active Implantable Medical Device Directive (AIMDD, 90/385/EEC), compliance with the ‘General Safety and Performance Requirements (GSPRs)’ is key to establishing conformity with the MDR.
The documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements
(Annex II, 1, no 4).
The demonstration of conformity shall include the general safety and performance requirements that apply to the device and an explanation as to why others
do not apply (Annex II, 1, no 4).
Whilst there were 13 ERs in the MDD and 16 in the AIMDD, there are 23 GSPRs in the new MDR.
This white paper1 offers a detailed comparison of the ERs in the MDD and AIMDD to the GSPRs in Annex I of the MDR. Ignore the implementation dates shown in the white paper as the information is no longer current.
1 White paper from BSI entitled General Safety and Performance Requirements (Annex I) in the New Medical Device Regulation – Comparison with the Essential Requirements of the Medical Device Directive and Active Implantable Device Directive
This blog post should help you to better understand the basics of the UDI system.
EU UDI helpdesk
Here is a link to the EU UDI helpdesk. This helpdesk aims to provide support to economic operators in the implementation of the obligations and requirements introduced by the new UDI system, which include:
- UDI assignment,
- labelling
- registration of devices.
This helpdesk will also provide support on the use of the European Medical Devices Nomenclature (EMDN), which the European Commission has made available to the manufacturers and other natural or legal persons required by the MDR and IVDR to use it.
A Factsheet for European Medical Device Nomenclature (EMDN) – Questions and Answers published on the Europa website is available here.
As defined in Article 2(35) of the MDR, all of the following are economic operators:
- Manufacturers
- Importers
- Authorised representatives
- Distributors
- Person referred to in Article 22(1) and Article 22(3) of the MDR i.e. natural or legal person
The following factsheets published on the Europa website are helpful to understand more about the responsibilities of each of the economic operators:
- Factsheet for manufacturers of medical devices -Basic information targeted at medical device manufacturers, including FAQs, available here.
- Factsheet for authorised representatives/importers/distributors – Basic information targeted at authorised representatives/importers/distributors of medical devices, including FAQs, available here.
What is EUDAMED?
EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
The system once completed, will be multipurpose. It will function as a:
- registration system,
- a collaborative system
- a notification system
- a dissemination system (open to the public) and will be interoperable.
What will EUDAMED help to achieve?
EUDAMED will improve transparency and coordination of information regarding medical devices available on the EU market.
The EUDAMED Modules
EUDAMED is structured around six interconnected modules and a public website. The table below provides information on the modules.
| Module | Module Number | Availability |
|---|---|---|
| Actors registration | 1 | Available for voluntary use since December 2020 |
| UDI/Devices registration | 2 | Available for voluntary use since October 2021 |
| Notified Bodies and Certificates | 3 | Available for voluntary use since October 2021, except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities |
| Clinical Investigations and performance studies | 4 | Under development and will be released when the entire EUDAMED system (including all six modules) is declared fully functional. |
| Vigilance and post-market surveillance | 5 | As above |
| Market Surveillance | 6 | As above |
The mandatory use of the system will start when the entire EUDAMED system (including all 6 modules) has been declared fully functional following an independent audit and a Commission notice to be published in the Official Journal and in accordance with the transitional provisions set out in the medical devices regulations.
The EUDAMED timeline is available here.
Source: Europa website
Placing on the market means the first time the device is made available, on the Union market (MDR Article 2(28) and IVDR Article 2(21).
Making available on the market means any supply of a device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge (MDR Article 2(27) and IVDR Article 2(20).
Putting into service means the stage at which a device has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose (MDR Article 2(29) (IVDR Article 2(22).
In all of the above cases, the following types of device are excluded:
•an investigational device
•a device for performance study according to the IVDR.
Post Market Surveillance (MDR Article 2(60))
It is all activities carried out by manufacturers working with other economic operators to put in place and keep up to date, a systematic procedure to proactively collect and review experience gained from devices:
- they place on the market,
- make available on the market
- put into service
for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.
Post Market Surveillance is required for all devices.
Vigilance (MDR Article 87(1))
Manufacturers of devices made available on the Union market, other than investigational devices, shall report, to the relevant competent authorities, in accordance with Articles 92(5) and 92(7), the following:
| (a) | any serious incident involving devices made available on the Union market, except expected side-effects which are clearly documented in the product information and quantified in the technical documentation and are subject to trend reporting pursuant to Article 88. |
| (b) | any field safety corrective action (FSCA) in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country. |
The reporting time frames for the incidents are as shown in the table below:
| Incident type | Reporting timeframe | Article of the MDR |
|---|---|---|
| Any serious incident as referred to in point (a) above | Immediately after the manufacturer has established the causal relationship between that incident and their device or that such causal relationship is reasonably possible and not later than 15 days after they become aware of the incident. | Article 87(3) |
| In the event of a serious public health threat | The report referred to in a/b above shall be provided immediately, and not later than 2 days after the manufacturer becomes aware of that threat. | Article 87(4) |
| In the event of death or an unanticipated serious deterioration in a person’s state of health | The report shall be provided immediately after the manufacturer has established or as soon as it suspects a causal relationship between the device and the serious incident but not later than 10 days after the date on which the manufacturer becomes aware of the serious incident. | Article 87(5) |
Market surveillance (MDR Article 2(61))
Market surveillance means the activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection.
This blog post provides basic information on the SSCP for medical devices.
This blog post provides information on Article 117 of the MDR, for Drug-Device Combination (DDC) products.
Legacy Devices are devices that are covered by a valid certificate issued in accordance with Directive 93/42/EEC, Directive 90/385/EEC or Directive 98/79/EC and that can continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR) by virtue of Article 120(3) of Regulation 745/2017 (MDR), and Article 110(3) of Regulation 746/2017 (IVDR).
The application dates of the MDR and IVDR are 26 May 2021 and 26 May 2022 respectively.
The Medical Device Coordination Group (MDCG) has published the following guidance documents on legacy devices:
MDCG 2019-5 – Registration of legacy devices in EUDAMED
MDCG 2020-6 – Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC
MDCG 2021-25 – Application of MDR requirements to “legacy devices” and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC
MDCG 2022-18 – MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate
About expert panels
The Medical Devices Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 on In Vitro Medical Devices (IVDR) respectively require the Commission to create expert panels to support the scientific assessment and advice in the field of medical devices and in vitro diagnostic medical devices.
Depending on needs, the expert panels have various tasks including provision of the following:
- an opinion on the notified bodies’ assessments of clinical evaluation of certain high-risk medical devices and the performance evaluation of certain in vitro diagnostic medical devices
- advice to the MDCG and the European Commission concerning safety and performance of medical devices and in vitro diagnostic medical devices
- advice to manufacturers on their clinical development strategy and proposals for clinical investigations
Here is a link to the Annual overview of devices subject to the clinical evaluation consultation procedure pursuant to Article 54(4) of Regulation (EU) 2017/745 on medical devices (April 2021- June 2022)
Who are the experts?
Panel members are top-notch experts in their own field appointed by the Commission on the basis of their scientific, clinical and technical expertise following a call for expression of interests. The selection is made by the Commission and the appointment in consultation with the MDCG.
The experts must have:
- full rights as a citizen of a Member State of the EU, EFTA or Turkey
- a university degree in a relevant medical or scientific areas
- at least 10 years of relevant professional experience
- good knowledge of the English language allowing active participation in the work of the panels
No financial interest or other interest, which could affect their independence, impartiality and objectivity.
How many expert panels are there?
Experts are appointed for a term of 3 years, with the possibility of renewal. During this time, they are part of one of 12 panels, which include the following:
- Screening panel – determines whether there is a need for a scientific opinion
- Orthopaedics, traumatology, rehabilitation, rheumatology
- Circulatory system
- Neurology
- Respiratory system, anaesthesiology, intensive care
The Commission provides a Secretariat for the expert panels to support the efficient functioning of the expert panels. Its task includes the identification and management of potential conflicts of interests, the supervision of the work, the monitoring of compliance with the rules of procedure, and the publication of opinions, views and positions.
Clinical Evaluation Consultation Procedure (CECP)
In addition to the procedures applicable pursuant to Article 52, a notified body shall also follow the procedure regarding clinical evaluation consultation as specified in Section 5.1 of Annex IX or as referred to in Section 6 of Annex X, as applicable, when performing a conformity assessment of the following devices:
(a) class III implantable devices, and
(b) class IIb active devices intended to administer and/or remove a medicinal product, as referred to in Section 6.4 of Annex VIII (Rule 12)
Article 54 of the MDR provides further details on those instances when the Clinical Evaluation Consultation Procedure (CECP) is not required.
Expert decisions in the context of the Clinical Evaluation Consultation Procedure (CECP) are published and can be viewed at the link below.
Source: Europa website
As you view the table below, you may also wish to view the MDR in HTML format at the same time allowing you to search quickly for the relevant chapter, Annex, Article etc.
| Acronym | In full | Location in the MDR (if applicable) | Definition |
|---|---|---|---|
| AIDC | Automatic Identification and Data Capture | Annex VI Part C(1) | AIDC is a technology used to automatically capture data. AIDC technologies include bar codes, smart cards, biometrics and RFID. |
| AIMDD | Active Implantable Medical Devices Directive 90/385/EEC | – | – |
| AR | Authorised Representative | Article 2(32) | Any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation |
| CA | Competent authorities | – | – |
| CAMD | Competent Authorities for Medical Devices | ||
| CS | Common Specifications | Article 2(71) | ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system. |
| EO | Economic Operator | Article 2(35) | ‘economic operator’ means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3); |
| EUDAMED | European Database on Medical Devices | Article 33 | EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on In vitro diagnostic medical devices. |
| FSCA | Field Safety Corrective Action | Article 2(68) | ‘field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market; |
| FSN | Field Safety Notice | Article 2(69) | ‘field safety notice’ means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action; |
| GMN | Global Model Number | – | Information about the Global Model Number is available in this leaflet from GS1. |
| GSPR | General Safety and Performance Requirements | Annex I | You can understand more about GSPR here. |
| HRI | Human Readable Interpretation | Annex VI Part C(1) | – |
| GTIN | Global Trade Identification Number | – | Information about the GTIN is available here on the GS1 website. |
| IFU/eIFU | Instructions For Use/electronic Instructions For Use | – | – |
| IMDRF | International Medical Device Regulators Forum | – | – |
| IVDD | In Vitro Medical Devices Directive 98/79/EC | ||
| IVDR | In Vitro Medical Devices Regulation (EU) 2017/746 | – | – |
| MDD | Medical Devices Directive 93/42/EEC | – | – |
| MDR | Medical Devices Regulation (EU) 2017/745 | ||
| MDCG | Medical Device Coordination Group | ||
| NB | Notified body | Article 2(42) | ‘notified body’ means a conformity assessment body designated in accordance with this Regulation; |
| PMS | Post-Market Surveillance | Art 2(60) and Article 83 | ‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive action |
| PMSP | Post-Market Surveillance Plan | Article 84 | The post-market surveillance system referred to in Article 83 shall be based on a post-market surveillance plan, the requirements for which are set out in Section 1.1 of Annex III. |
| PMSR | Post-Market Surveillance Report | Article 85 | Manufacturers of class I devices shall prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together with a rationale and description of any preventive and corrective actions taken. The report shall be updated when necessary and made available to the competent authority upon request. |
| PMCF | Post-Market Clinical Follow-up | Annex XIV Part B | PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of Annex XIV and shall be addressed in the manufacturer’s post-market surveillance plan. |
| PSUR | Periodic Safety Update Report | Article 86 | Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together with a rationale and description of any preventive and corrective actions taken |
| QMS | Quality Management System | Article 10(9) | – |
| RFID | Radio Frequency Identification | Annex VI Part C(1) | RFID is a technology that uses communication through the use of radio waves to exchange data between a reader and an electronic tag attached to an object, for the purpose of identification. |
| SRN | Single Registration Number | Article 31(2) | |
| SSCP | Summary of Safety and Clinical Performance | Article 32 | For implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance |
| TD | Technical Documentation | Annex II Annex III is TD III on post market surveillance. | – |
| Basic UDI-DI | Unique Device Identification –Device Identifier | Annex VI Part C(1) | The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity |
| UDI-DI | Unique Device Identification- Device Identifier (UDI-DI) | Art. 27 1 a(i) | – |
| UDI-PI | Unique Device Identification- Production Identifier (UDI-PI) | Art. 27 1 a(ii) | – |
Yes, there is a Q & A available. Here, you can view the track changed (June 2021) and clean (Nov 2023 Rev 3) versions of the document.
| Implementing regulation or decision | What does it concern? | Brief explanatory notes |
|---|---|---|
| Commission Implementing Decision (EU) 2024/815 of 6 March 2024 | Amends Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products | |
| Commission Implementing Decision (EU) 2023/1410 of 4 July 2023 | Harmonised standards for sterilization of health care products and biological evaluation of medical devices. | Amends Implementing Decision (EU) 2021/1182 as regards harmonised standards for sterilization of health care products and biological evaluation of medical devices. This Decision shall enter into force on the day of its publication in the Official Journal of the European Union. It will enter into force on 5 July 2023. |
| Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023 | Transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 | Amends Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council (Text with EEA relevance). This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 22 June 2023. |
| Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 | Reclassification of groups of certain active products without an intended medical purpose | Lays down rules for the application of Regulation (EU) 2017/745 as regards reclassification of groups of certain active products without an intended medical purpose . This Regulation is applicable and shall be binding in its entirety and directly applicable in all Member States. |
| Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 | Common specifications | Lays down common specifications in accordance with Regulation (EU) 2017/745. It shall apply from 22 June 2023. However, Article 2(3) shall apply from 22 December 2022. |
| Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746 | Common specifications | Lays down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746. It shall apply from 25 July 2024. |
| Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 | Electronic instructions for use of medical devices (eIFU) | Lays down the rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices (eIFU). This regulation became applicable on 4 January 2022. |
| Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 | European Database on Medical Devices (Eudamed) | Lays down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed). |
| Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 | Common specifications for the reprocessing of single-use devices | Lays down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices This regulation became applicable from from 26 May 2021 |
| Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 | List of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the filed of medical devices and in vitro diagnostic medical devices | List of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council This regulation became applicable on 24 November 2017 |
| Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 | Designation of expert panels. | Lays down the rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the designation of expert panels in the field of medical devices. Entered into force on 30 September 2019. |
| Commission Implementing Decision (EU) 2019/939 of 6 June 2019 | Designating issuing entities | Designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices. Entered into force on 27 June 2019. |
On 20 March 2023, Regulation (EU) 2023/607 amending the MDR and the IVDR as regards the transitional provisions for certain medical devices and IVDs was published.
- The Regulation introduces a staggered extension of the transition period provided for in Regulation (EU) 2017/745 on medical devices (MDR), subject to certain conditions.
- It also deletes in both MDR and IVDR the “sell-off” deadline after which devices placed on the market before or during the transition periods that are still in the supply chain would have had to be withdrawn.
This Regulation entered into force on 20th March 2023, the day of its publication in the Official Journal of the European Union.
Further information is available in this blog post.
Applicable Medical Devices Legislation in Northern Ireland
On 31 January 2020, the UK ceased to be a member of the EU.
Under the terms of the Northern Ireland Protocol, from 1 January 2021, the rules for placing medical devices on the Northern Ireland market differ from those applicable to placing medical devices on the market in Great Britain (England, Wales and Scotland).
The MDR applies in Northern Ireland since 26 May 2021, and the IVDR applies in Northern Ireland since 26 May 2022, in line with the EU’s implementation timeline.
Conformity assessment marking
- For medical devices and IVDs, CE marking will continue to be used and recognised for the Northern Ireland market and manufacturers based in Northern Ireland will not require an authorised representative established in the EU.
- If a device manufacturer uses an EU-recognised Notified Body for mandatory third-party conformity assessment, the CE marking on its own is sufficient to place a device on the Northern Ireland market.
- Where a UK Notified Body has been used for your conformity assessment, CE UKNI mark must be placed on the device.
- Goods bearing the CE UKNI marking will not be accepted on the EU market.
- To place a CE marking on your device for circulation in both Northern Ireland and the EU, you must use an EU-recognised Notified Body to undertake any mandatory third-party conformity assessment. The results of conformity assessments carried out by UK Notified Bodies are not recognised within the EU.
- Further guidance on applying the UKNI marking is available here.
Other requirements
- Certain medical devices, including in vitro diagnostic medical devices (IVDs), placed on the Northern Ireland market need to be registered with the MHRA
- all custom-made devices must be registered with the MHRA within 28 days of being made available on the Northern Ireland market
- when placing devices on the Northern Ireland market, Great Britain-based manufacturers must appoint an EU or Northern Ireland-based Authorised Representative
Source: UK MHRA
- The European Commission website is a good place to start when looking for guidance on Medical Devices or new or updated legislation and you can access it here. On this page, you will find a selection of very useful leaflets which provide basic information on a range of topics concerning medical devices .
- The Medical Device Coordination Group (MDCG) issues guidance on an ongoing basis and you can find all MDCG endorsed guidance and other guidance here.
- Much useful information, including guidance documents, white papers, webinars etc. can be found on the websites of the following organisations:
- Business Finland has supported a guide entitled European Medical Device regulations MDR and IVDR – A Guide to market. This 110 page guide could be a good starting point if you are new to medical devices. You can download a copy here.