Introduction:
Ireland is an island in the North Atlantic. It is the island separated from Great Britain to its east by the North Channel, the Irish Sea, and St George’s Channel. Ireland is the third-largest island in Europe. Although Ireland’s economy is strong compared to its European neighbors, the medical device market will grow modestly over the next few years. The Irish market was valued at the US $.72 billion in 2016 and will increase to $.83 billion by 2020. The medical device manufacturing industry in Ireland is robust. In fact, many of the top medical device companies have operations in Ireland. However, the domestic manufacturing industry is based on exports; Ireland is one of the top medical device exporters in Europe. We are very pleased that as a Turnkey project consultant we have got chance to work with them and we are currently working on new projects as well.
The term medical device covers a very wide range of products, excluding medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or handicap and includes many thousands of items used each day by healthcare providers and patients. It also includes in-vitro diagnostic (IVD) test kits, reagents, laboratory analyzers and related software, etc.
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Medical Device Registration in Ireland
The regulatory authority responsible for medical device registration in Ireland is the Health Products Regulatory Authority (HPRA), formerly known as the Irish Medicines Board. The HPRA monitors the safety and quality of medical devices in the country.
Which Regulation Governs Medical Device Registration in Ireland
The regulation governs medical device registration in Ireland are:
- Health Products Regulatory Authority (HPRA) (formerly the Irish Medicines Board).
- European Medicines Agency (EMA).
- Environmental Protection Agency (EPA).
In Ireland, medical device registration is governed by the EU Medical Device Regulation (MDR) 2017/745. This regulation sets the standards and requirements for the registration and oversight of medical devices in the country. The Health Products Regulatory Authority (HPRA), formerly known as the Irish Medicines Board, is the national competent authority responsible for enforcing the MDR and ensuring compliance with its provisions. The HPRA regulates various aspects of medical devices, including their safety, quality, manufacturing, distribution, and post-market surveillance. Compliance with the MDR is mandatory for manufacturers and importers who wish to place their medical devices on the Irish market. The HPRA also works closely with the European Medicines Agency (EMA) and the Environmental Protection Agency (EPA) to ensure comprehensive regulation of medical products in Ireland.
Medical Device Legislation in Ireland:
The Irish Medicines Board (i.e IMB) is the competent authority for the regulation of medical devices on the Irish market, being the competent authority appointed under the Medical Devices Legislation. The IMB serves to ensure that all such devices which are placed on the market in Ireland meet the essential requirements of the Medical Devices Legislation.
There are three types of medical devices outlined in the legislation. They are as follows:
- General medical devices
- active implantable medical devices
- in-vitro diagnostic medical device.
Medical devices are divided into classes dependent on risk which can be low, medium and high risk. The scope of medical device regulation also includes in vitro diagnostic (IVD) medical devices. An IVD medical device includes any medical device (such as a reagent, reagent product, calibrator, control material, instrument, apparatus) that is used alone or in combination and that is intended by the manufacturer to be used in vitro to provide information on, for example, a physiological or pathological state or to monitor therapeutic measures. These include pregnancy test kits, urinalysis test strips and specimen receptacles (such as blood collection tubes).
What is the Registration Process for Medical Devices in Ireland?
The registration process for medical devices in Ireland involves several steps:
- Determine device classification: Identify the appropriate classification for your medical device based on its intended use and risk level.
- Appoint Authorized Representative and Notified Body: For higher-risk devices, appoint an Authorized Representative and engage with a Notified Body for conformity assessment.
- Prepare documentation: Create a CE Technical File, which includes the necessary technical documentation, such as risk management plans, clinical studies reports, and labeling information.
- Obtain and register UDI in EUDAMED: Obtain a Unique Device Identifier (UDI) and register it in the European Databank on Medical Devices (EUDAMED).
- Notified Body audit: For certain device classes, undergo an audit by a Notified Body to assess compliance with the applicable standards and regulations.
- Declaration of Conformity: Once your device meets all requirements, prepare a Declaration of Conformity stating that it complies with the relevant regulations.
- Post-market surveillance: Establish post-market surveillance procedures to monitor device performance, report any incidents, and ensure ongoing compliance.
What Documents are Required for Medical Device Registration in Ireland?
The documents typically required for medical device registration in Ireland include:
- CE Certificate or UKCA certificate
- Declaration of Conformity
- Technical File
- Quality Management System (QMS) Certificate
- Risk Management Plan
- Instructions for Use (IFUs), labels, or user manuals
- Clinical Studies Report
- Post-market surveillance plan
What are the Post-Market Requirements for Medical Devices in Ireland?
For medical devices placed on the Irish market, there are specific reporting requirements:
- Serious public health threats: Report within 2 days.
- Death or serious health deterioration: Report within 10 days.
- Other serious incidents: Report within 15 days.
Streamline Medical Device Registration in Ireland with Operon Strategist
As discussed in this blog you need to find out what type of registration you want , to avoid confusion it is always better to speak with our team .we have an experienced team as we are medical device regulatory consultant , we are handling national as well as international projects and providing regulatory solutions to all. Operon Strategist has expertise in handling Medical Device Turnkey Projects all around the world. And have experience of setting up small, medium and large medical device manufacturing plant layout design facilities in every domain of medical devices.
FAQs
What is the applicable quality management standard for medical devices in Ireland?
The applicable quality management standard for medical devices in Ireland is ISO 13485. Compliance with this standard is essential to ensure the quality and safety of medical devices.
Do medical devices require an authorized representative in Ireland?
Yes, manufacturers based outside the European Union need to appoint an authorized representative in Ireland to act on their behalf for regulatory compliance purposes.
What is the validity period of a medical device license in Ireland?
Medical device licenses in Ireland are typically valid for 5 years.
Is there any language requirement for labeling and documentation in Ireland?
Labels, instructions for use (IFUs), and other documentation should be provided in either Irish or English languages.
