Medical devices and in vitro diagnostic medical devices have a significant role in protecting patients and public health by diagnosing, preventing, monitoring, predicting and treating illness.

The above regulations replace previous Directives.  Both entered into force in May 2017. However, as a consequence of the global outbreak of COVID-19, full application of both regulations was extended. 

The Medical Devices Regulation (EU) 2017/745 is known as the MDR, and the In Vitro Diagnostics Medical Devices Regulation (EU) 2017/746 is known as the IVDR.

The MDR became fully applicable on 26 May 2021 and the IVDR will have a staggered application from May 2022. These new regulations are expected to result in significant improvement and development of the regulatory system for medical devices and in vitro diagnostic devices.

MDR

The initial HSE compliance focus has been on Class III and implantable devices together with the requirements for Unique Device Identification (UDI) and implant cards. Class III medical devices are those devices that have a high risk to the patient and/or user. Examples of Class III devices include implantable pacemakers and breast implants. The term 'medical device' covers all products used in healthcare for the diagnosis, prevention, monitoring or treatment of an illness or injury or disability and which achieves its principal intended action by physical means.  The range of products is very wide and includes many thousands of items used each and every day by healthcare providers and patients. It includes: contact lenses and condoms; heart valves and hospital beds; resuscitators and radiotherapy machines; surgical instruments and syringes; wheelchairs and walking frames or other assistive technology products; pregnancy tests, blood glucose monitors and pacemakers.  

IVDR

In vitro diagnostics are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person's overall health to help cure, treat, or prevent diseases. 

This year a new Regulation (Regulation (EU) 2022/112 of 25 January 2022) was published amending the IVDR as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices.

The length of transition periods depends on the type of device:  higher risk devices have shorter transition periods than lower risk ones. In addition the application of most of the conditions to be met by health institutions making in-house devices is being deferred by two years until 26 May 2024. 

HPRA

In Ireland, the Health Products Regulatory Authority (HPRA) is the designated national competent authority and market surveillance authority for medical devices and in vitro diagnostic medical devices. This means they are responsible for regulating medical devices and in vitro medical devices in Ireland. The HPRA has a specific regulatory role involving the designation of notified bodies, authorisation of clinical investigations and monitoring the safety and compliance of medical devices in Ireland, through market surveillance activities after they are placed on the market. The HPRA is the national authority responsible for enforcing the MDR and IVDR. 

For further clarification on MDR and IVDR visit the HPRA website.

Main features of the new MDR include: 

• Introduction of a UDI (Unique Device Identifier) including a traceability system
• Enhanced provisions for market surveillance
• Provision of clear and easily accessible essential information on implant devices to patients including clear identification of the implant
• Improved performance of notified bodies* for medical devices.
• Clearer requirements for clinical data on medical devices and its assessment.
• New obligations apply for economic operators that include post-market surveillance for devices they place on the market.
• More specific product requirements
• Improved pre-market assessment of high risk devices
• Governance, coordination and cooperation
• Stricter pre-market control of high-risk devices with the involvement of a pool of experts at EU level
• Inclusion of certain aesthetic devices within the scope
• EU minimum requirements related to reprocessing of single-use devices
• Establishment of a comprehensive EU database on medical devices (EUDAMED) with large part of information to be made publicly available

* A notified body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market.

To ensure compliance with these new regulatory requirements it is essential that all services within the HSE are aware of the new EU Regulations and the respective HSE obligations outlined in the relevant articles associated with the implementation of the regulations.

The HSE in partnership with the Department of Health (DoH) is in the process of completing an implementation pathway to ensure compliance with the various HSE responsibilities as obliged by the related articles contained in the regulations.

A central component to the pathway of the new MDR compliance is engagement with relevant stakeholders within the HSE to clearly communicate the implementation requirements of the new Regulations such as:

1. Provision to improve traceability of medical device within healthcare institutions.               
2. Obligations on distributors of medical devices.         
3. Reporting adverse incidents involving medical devices.
4. Reprocessing of single-use medical devices                 
5. In-house manufacture of medical devices
6. Clinical Investigations of medical devices 

Related Information

Information Briefing Medical Device Regulations (vimeo video, length 1hr.57min)

Medical Device Regulation – HPRA Presentation 15/09/2021 (PDF, size 1.23 MB, 34 pages)

Medical Device Regulations Update – HSE Presentation 15/09/2021 (PDF, size 500 KB, 18 pages)

MDR implementation 2021 

The application of the MDR Regulations has commenced with the MDR becoming fully applicable on 26th May 2021.

The respective obligations associated with implementation of the relevant articles under the MDR will centre on number of key elements of implementation to ensure compliance with the new requirements.

The following 8 key elements relate to the HSE’s obligations and responsibilities with regard to the implementation of the MDR:  

Priority HSE tasks related to Class III and implantable medical devices 

(1)   Identification of the key stakeholders within the HSE relative to implantable devices and Class III devices.

(2)   Each hospital /service area designate a senior operational lead to oversee, co-ordinate and advance compliance requirements with the associated articles for Class III devices.

(3)   Engagement with manufacturers, Authorised Representative and Distributors in the provision of assurances on their compliance with: 

• Manufacturer assignment of UDI code for Class III devices and provision of data to UDI database
• Traceability system for Class III medical devices
• Provision of Patient Implant Cards
• Notified Body identification for the devices supplied
• Provision of a system to address any issues/complaints with their devices as effectively as possible

(4)   Provision of Implant Cards (IC) to be provided to achieve three main objectives:

• Enable the patient to identify the implanted devices and to get access to other information related to the implanted device (e.g. via EUDAMED, and other websites).
• Enable patients to identify themselves as persons requiring special care in relevant situations e.g. security checks.
• Enabling e.g. emergency clinical staff or first responder to be informed about special care/needs for relevant patients in case of emergency situations.

 a) Manufacturer Implant Card Obligations: 

In accordance with Article 18 of the MDR, the manufacturer should provide the following 5 pieces of information on the IC (preferably on the card itself or, alternatively, as stickers to be placed by the clinician):

• Device name
• Serial number, lot number
• Unique Device Identification (UDI)
• Name, address and the website of manufacturer
• Device type

b) Health Institution or Healthcare Provider Implant Card Obligations:

In the context of national implementation of Article 18 of the MDR, only the following 3 pieces of information are required to be provided directly to patients implanted with a device by the health institution or healthcare provider on the IC (together with the information provided by the manufacturer).

• Name of the patient or patient ID
• Name and address of the health institution or healthcare provider who performed the implantation
• Date of implantation 

(5)   Hospital electronically record all Class III medical devices including UDI codes together with the following data set as a minimum:

• Manufacturer / distributor company name
• Device model / or name
• Device serial number / Unique device number / UDI code
• Patient name
• Patient contact details

(6)   Hospitals establish a local process for reporting and recording of Serious Incidents together with reporting to the National Incident Management System (NIMS) and to the Health Products Regulatory Authority (HPRA).

(7)   The MDR (Article 17) includes specific provisions allowing for the reprocessing of SUDs only where permitted by Member States at a national level. The national position in Ireland is set out in the Medical Devices Regulations S.I. 261 of 2021 and allows reprocessing of SUD (single-use device) only in accordance with Article 17(2) of the MDR. As a result, any entity reprocessing SUDs in Ireland will be considered the legal manufacturer of the reprocessed device.

 (8)   Hospital Identification of any In-House Manufacturing. Where identified, ensure compliance with the obligations specified in Article 5 (5) of the MDR.

Class III and implantable medical devices

Rule 6 & 7 EU classification of Class III surgical invasive medical devices

• Surgical invasive device 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.
• Surgical invasive device intended specifically for use in direct contact with the heart or central circulatory system or central nervous system.
• Cardiovascular Catheters (e.g. angioplasty balloon catheters, stent delivery catheters/systems) including guide wires and disposable cardiovascular surgical instruments e.g. electrophysiological catheters, electrodes for electrophysiological diagnosis and ablation
• Thoracic catheters to drain the heart, carotid artery shunts & ablation catheters
• Catheters containing or incorporating sealed radioisotopes if used in the central circulatory system.
• Distal protection devices (used in Cath labs)
• Temporal Pacemaker leads, cardiac output probes
• Spinal needles, spinal cord retractors, direct stimulation cannula, brain spatulas, neuro endoscopes.
• Absorbable sutures and biological adhesives

Rule 8 EU classification of Class III implantable medical devices

• Prosthetic joint replacements
• Spinal disc replacement implants
• Total hip, knee and shoulder replacement systems and components of systems
• Nail and plates
• Intra-ocular lenses
• Internal closure devices
• Tissue augmentation implants
• Peripheral vascular grafts and stents
• Penile implants
• Non-absorbable suture, bone cements and maxilla-facial implants, visco-elastic surgical devices intended for ophthalmic anterior segment surgery
• Ligaments
• Shunts
• Pulmonary stents and valves
• Prosthetic heart valves
• Aneurysm clips
• Vascular prosthesis and stents
• Central vascular catheters
• Active implantable device or their accessories
• Implantable device intended to be used in direct contact with the heart, central circulatory system or central nervous system
• Implantable device to administer medicinal products
• Spinal stents
• CNS electrodes
• Cardiovascular sutures
• Permanent and retrievable vena cava filters
• Septal occlusion devices
• Intra-aortic balloon pumps
• Rechargeable non-active drug delivery systems
• Breast implants
• Surgical meshes 

Rule 17 EU classification of Class III devices utilising animal tissues or derivatives

• Biological heart valves
• Porcine xenograft dressings

In-house manufacturing 

The Regulations allow health institutions under certain conditions to manufacture, modify and use devices ‘on a non-industrial scale’ when equivalent ones are not available commercially (MDR Article 5). With the exception of the general safety and performance requirements set out in MDR Annex I, in-house devices are exempt from the requirements of the Regulations as long as they are not transferred to another legal entity. Nevertheless, health institutions should have appropriate quality management systems in place; compile documentation on the manufacturing process, the design and performance data of the devices, including their intended purpose; and review the experience gained from the clinical use of the devices and take all necessary corrective actions.

This information shall be made available to competent authorities on request, and a declaration with certain details should be made publicly available.

If healthcare professionals manufacture and use devices that do not comply with Article 5 they must follow the same rules as manufacturers.

Member States may require that such health institutions submit to the competent authority any further relevant information about such devices that have been manufactured and used on their territory. Member States shall retain the right to restrict the manufacture and use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions.

Reprocessing Single Use Devices (SUD) 

The MDR allows for reprocessing of single-use medical devices to enable their safe re-use, as long as this is also permitted by national law and only in accordance with MDR Article 17.

The Republic of Ireland allows reprocessing of SUD only in accordance with Article 17(2) of the MDR in accordance with SI 261/2021. As a result, any entity reprocessing SUDs in Ireland will be considered the legal manufacturer of the reprocessed device.

Health institutions can use reprocessed devices provided by commercial reprocessors, however such commercial reprocessors should be fully compliant with Article 17.2 and fulfil the responsibilities of a manufacturer in full.

A person shall not reprocess a single-use device to make it suitable for further use in a member state unless there is compliance with Article 17(6), and (8) of the EU Regulation.

The HSE current policy is that single use devices should not be re-processed as outlined in the HSE Standards and Recommended Practices for Central Decontamination Units.

However, hospitals may undertake re-processing in line with the manufacturers’ Instructions for Use (IFU) for operational reasons. This may be an occasion or continuous practice within a hospital. Where re-processing of single use devices is conducted in line with the manufacturers’ IFU the hospital will not take on the role of the manufacturer under the MDR. If a hospital goes beyond the manufacturers’ IFU  for operational reasons, they will be considered the manufacturer under the MDR and will need to ensure a process is in place to deliver full compliance with all MDR requirements including Article 17.

Obligations and regulatory requirements of economic operators

Economic Operator means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3).

The Regulations clarify the respective obligations of manufactur­ers, authorised representatives, importers and distributors (MDR and IVDR Articles 10 to 16).

For manufacturers, the Regulations add new requirements and reinforce existing requirements. Manufacturers have to put systems in place for risk and quality management, conduct clinical or performance evaluations, draw up technical documentation and keep all of this up to date. Manufacturers are also required to apply conformity assessment procedures in order to place their devices on the market. The level of clinical evidence needed to demonstrate the conformity of a device depends on its risk class.

Once they have completed their obligations, manufacturers should draw up a declaration of conformity and apply the CE mark to their devices:

The Regulations also clarify the distinction between vigilance and post-market surveillance. The former includes identifying and reporting serious incidents and conducting safety-related corrective actions. It requires direct and efficient cooperation between healthcare professionals, health institutions, manufacturers and national competent authorities for medical devices. Post-market surveillance involves monitoring the available information to periodically reconfirm that the benefits of the device continue to outweigh its risks.

The Regulations require manufacturers to implement post-market surveillance follow-up plans. This includes compiling safety reports and updating the performance and clinical evaluation throughout the life cycle of a device. This could lead to manufacturers calling on health institutions to provide more information about their experience with their medical devices. Health institutions could prepare for this by thinking about convenient ways to gather information about their experience with medical devices.

Manufacturers outside the EU market should have a contract with an authorised representative inside the EU.

Health institutions as distributors and/or importers 

Health institutions themselves fall within the scope of the Medical Devices Regulation 2017/745 (MDR) and have a number of obligations to comply with under the revised regulatory framework.  However, health institutions may also undertake the roles of a distributor and/or importer if they meet the definitions provided for in Article 2 of these regulations:

‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market ¹, up until the point of putting into service;

 ‘importer’ means any natural or legal person established within the Union that places a device² from a third country on the Union market;

Both distributors and importers make the device available on the EU market to other entities. These entities can be any natural or legal person, which could include businesses, patients, pharmacies, surgeries or other health institutions. In the case of importers, the making available is the ‘first making available’ (also called the ‘placing on the market’) of these devices from an entity based in a third country (i.e. any country that is not part of the EU or EEA, e.g. UK or US). The transfer of ownership, making available or placing on the market may be in exchange for remuneration or free of charge.

Under the MDR/IVDR the placing on the market/making further available of devices is dependent on a legal transfer of ownership. A health institution that transfers devices to another natural or legal entity (via a physical, legal or financial transfer of ownership) could be acting as an importer or distributor under Article 2. However, where the health institution is the end-user and does not transfer the device to another natural or legal person, the health institution would not be a distributor within the meaning of the MDR/IVDR.

Conversely, when a device is transferred (legally or financially) to a health institution from a non-EU entity, its release for ‘free circulation’ by customs authorities generally coincides with placing on the market.^3,4 Therefore, health institutions that import medical devices from third countries are placing them on the market and are acting as importers, regardless of whether or not the devices are for onward supply.

¹ making available on the market’ shall mean any supply of a product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge
² placing on the market shall mean the first making available of a product on the Community market
³ see the European Commission’s Interpretative Document Placing on the market of Medical Devices
⁴ see Regulation 765/2008

For the devices that health institutions import or distribute, the roles and responsibilities of an importer or distributor called out in the MDR will apply in full. These specific requirements are called out in Articles 13 (Importer obligations) and Articles 14 (Distributor obligations), however all economic operators are required to comply with the MDR in full. Articles 13 and 14 call out the need for complaint handling, reporting, correct storage/transport and verification checks (e.g. of the CE mark and UDI assignment) in detail.

Additionally, health institutions need to ensure compliance with provisions such as Article 25 (Identification within the supply chain) regardless of whether they incur the role and responsibilities of an importer/distributor. It is likely that some, but not all health institutions and their affiliated organisations operate as an importer/distributor.

Any entity which suspects their activities may qualify them as a distributor or an importer should review the definitions provided for in Article 2 and the obligations set out in Articles 13 and 14. To further aid stakeholders, the HPRA have developed the Guide for Distributors of Medical Devices, an online webinar outlining the Economic Operators Obligations within the supply chain and an Interim FAQ on Importer Obligations

Key Facts for healthcare professionals and health institutions

What has changed?

In general, no requirements from the Directives (MDD) have been removed; the Regulations (MDR) add new ones. Compared to the current Directives, the new Regulations emphasise a life-cycle approach to safety, backed up by clinical data.

Certificates issued by Notified Bodies under the MDD will remain valid until their date of expiration or until 27 May 2024 at the latest, with some exceptions described in MDR Article 120(2)) for certain certificates. Valid MDD devices may continue to be made available on the market and circulate in the supply chain up until 2025. Until May 2025, MDR devices and some MDD devices will coexist on the market. Both will have equal status under the law, and no discrimination in public tenders may take place. Devices that are in stock in health institutions can still be used after 2025 until they reach their expiration dates. Furthermore, the Regulations do not regulate the further making available of devices, including after 25 May 2025, after they have already been made available or put into service, for example in the case of second-hand sales (MDR recital 3).

Risk classification of devices and scope of the regulations

The classification of MDs into four classes (Class I, IIa, IIb, III) remains, but the MDR reclassifies certain devices and has a wider scope. For example, the Regulation explicitly covers devices for cleaning, sterilising or disinfecting other medical devices. The Regulation also covers reprocessed single-use medical devices, and certain devices with no intended medical purpose (MDR Chapter I and Annex XVI).

Clinical investigations (MDR Articles 62 to 82)

The rules on clinical investigations for medical devices under the MDR have been reinforced. The new rules describe clearly how these investigations shall be designed, notified and/or authorised, conducted, recorded and reported. If you are a sponsor or take part in clinical investigations or performance studies, please read the relevant articles carefully so that you are informed of all the new obligations.

Traceability

A completely new feature of the Regulations is the unique device identification (UDI) system (MDR Article 27, which will apply to all devices placed on the EU market. The UDI will be a barcode, a QR code or any other machine-readable code. This will enhance the identification and traceability of devices and the effectiveness of post-market safety-related activities through targeted field safety corrective actions and better monitoring by competent authorities. Economic operators shall be able to identify any health institution or healthcare professional to which they have directly supplied a device (MDR Article 25). UDI should also help to reduce medical errors and fight against falsified devices. Use of the UDI system should also improve purchasing, waste disposal and stock management by health institutions and other economic operators.

Identification

Unique device identifiers (UDIs) will be used to uniquely and unambiguously identify devices, both individually and when packaged, or in the case of reusable devices by direct marking of the device itself. Each MD when applicable, each level of their packaging will have a UDI that will be indicated on the labels. UDIs will be added to labels in stages but will be completed by 2027, depending on the risk class of the device. For Class III implantable devices, health institutions shall store and keep – preferably by electronic means – the UDIs of the devices they have supplied, or with which they have been supplied (MDR Article 27(9)). The MDR invite Member States to encourage and to require health institutions to store and keep the UDIs of the devices with which they have been supplied. Also, Member States shall encourage, and may require, healthcare professionals to store and keep the UDIs of the devices with which they have been supplied.

EUDAMED database

 The Regulations will increase transparency by making the UDI the key to publicly available information on devices and in studies. EUDAMED, the new European database for medical devices and in vitro diagnostic medical devices, will play a central role in making data available and increasing both the quantity and quality of data (MDR Article 33). The central European database will allow all stakeholders to access basic information on MDs, such as the identity of the device, its certificate, the manufacturer, the authorised representative and the importer. The EUDAMED database (MDR Article 92) will adequately inform the public, including healthcare professionals, about:

• clinical investigation reports on medical devices, the summaries of the main safety and performance aspects of the device, and the outcome of the clinical/performance evaluation;
• field safety notices by manufacturers and certain aspects of serious incident reports

Healthcare professionals can use this information and may expect questions from patients about what they have read in EUDAMED. In addition, Member States shall take appropriate measures, such as organising targeted information campaigns, to encourage and enable healthcare professionals, users and patients to report to the competent authorities on suspected serious incidents occurring with devices (MDR Article 87(10).

In-house devices

The Regulations allow health institutions under certain conditions to manufacture, modify and use devices ‘on a non-industrial scale’ when equivalent ones are not available commercially (MDR Article 5). With the exception of the general safety and performance requirements set out in MDR Annex I, in-house devices are exempt from the requirements of the Regulations as long as they are not transferred to another legal entity. Nevertheless, health institutions should have appropriate quality management systems in place; compile documentation on the manufacturing process, the design and performance data of the devices, including their intended purpose; and review the experience gained from the clinical use of the devices and take all necessary corrective actions.

This information shall be made available to competent authorities on request, and a declaration with certain details should be made publicly available.

If healthcare professionals manufacture and use devices that do not comply with Article 5 they must follow the same rules as manufacturers.