HPRA inspections for medical devices and IVDs

This webpage provides information for medical device industry about our process for conducting inspections, and the different types of inspections.

Who do we inspect and why?

We inspect medical device and in vitro diagnostic (IVD) medical device manufacturers, authorised representatives, importers, distributors, suppliers and sub-contractors.

The aim of an inspection is to ensure that a company is compliant with the applicable requirements of the relevant legislation.

How do we select candidates for inspection?

For cause inspections

We carry out ‘for cause’ inspections in response to market issues which require follow-up in the interest of public health. This may include device safety issues or complaints received about CE marked devices.

We must investigate public health issues by whatever method is appropriate. Where we decide to conduct a for cause inspection, a request to go onsite at once may be made. We will only change the date of the visit in exceptional circumstances.

Proactive inspections

An inspection by us does not mean that there has been a breach of law, it may be part of a proactive programme of market surveillance.

We carry out announced or unannounced inspections. For announced inspections, we will generally give the candidate approximately four weeks’ notice where possible.

The inspection process

We have provided an overview of our inspection process below and what to expect before, during and after the inspection.

Who will conduct the inspection?

Authorised officers (AO) conduct our inspections. S.I. No. 261 of 2021 for medical devices and S.I. 256 of 2022 for IVDs outline the meaning and powers given to AOs. Our AOs may be accompanied by other colleagues where needed.

What will we inspect?

Typically, during a HPRA inspection, there will be:

• a review and assessment of quality management and regulatory compliance,

• a review and analysis of processes and records,

• interviews with relevant personnel,

• inspection of premises, equipment, manufacturing, storage etc.

This is not an exhaustive list.

Before the inspection

We may contact the candidate to arrange the date, time and duration of the inspection. We may ask the candidate to provide information in advance of the inspection such as their company profile, a list of product manufacturers, notified body details, procedures and records, etc.

During the inspection

We will outline the inspection process, scope and plan. We will take note of any areas of concern and discuss these when they arise with the candidate.

We may ask for samples of devices or device packaging if needed. We will present our findings and outline any non-compliance(s) to the relevant legislation.

After the inspection

We will issue a non-compliance report. It is expected that a Corrective Action Preventative Action (CAPA) approach will be applied to non-compliances. For more details about the various types of non-compliances and how to apply a CAPA approach, please review our HPRA inspections webinar presentation.

Once we receive satisfactory responses to non-compliances, we will issue a letter to the candidate to that effect. Where we do not receive satisfactory responses and/or where breaches of the regulations have taken place, we may take further action.

Non-compliance types

Critical

This is a flaw which leads to a significant risk of producing a product which may present an unacceptable risk to the health or safety of patients, users or others. This may require immediate action.

Major

This is a flaw which indicates a major deviation from MDR or IVDR requirements. This could also be a combination of several minor non-compliances. Multiple minor compliances together may be a major non-compliance. Candidates should explain and report this as such.

Minor

This is a flaw which cannot be classified as a critical or major non-compliance, but still represents a deviation from MDR or IVDR requirements.

Observation / Comment

This is a finding or statement to prompt the manufacturer to improve future practice, performance or procedures.

Types of inspection

We have provided information about the various types of inspections we conduct below:

On-site inspections

This is an in-person inspection, where our inspection team is physically present at the site for the duration of the inspection.

Remote inspections

This is a distant inspection, where our inspection team is not at the site. We conduct the inspection via a web communication platform.

Hybrid inspections

This inspection is a combination of the above. The inspection team may split either in time or in location during the inspection.

Remote and hybrid inspections will follow a similar format to on-site inspections. To avoid delays, we may ask candidates to provide electronic copies of documents and other information to us in advance of the inspection.

We may use platforms for the live sharing of documents and videos. We may also use cameras to allow for a virtual review of physical facilities, equipment and manufacturing operations.

A remote inspection on its own may not be sufficient to determine the level of compliance with requirements. In some cases, an on-site inspection may be necessary. This would focus on areas of the site that we could not be inspect remotely and/or areas requiring further follow-up from the remote inspection.

The information covered on this page as well as specific details for different inspection candidate types and the application of a CAPA approach is also outlined in our HPRA inspections webinar presentation.

Contact us

If you would like more details about our inspection activities, please contact a member of the inspection team at devices@hpra.ie.