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In order to obtain a CE mark for a device, a manufacturer must demonstrate the basic safety and performance of the device and conformance of the device with the essential requirements described in Annex I of the relevant Directive. This demonstration of conformance must include an evaluation of this data, referred to as ‘clinical evaluation’, should follow one of the following procedures:
a) a critical evaluation of the relevant scientific literature currently available relating to the device
b) a critical evaluation of the results of all clinical investigations generated for the device
c) a critical evaluation of the combined clinical data provided in a) and b) above

Below listed application forms are attached:

  1. Application form for Clinical Investigations of Medical Devices
  2. Application for Amendments to Clinical Investigations of Medical Devices
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The ‘Application for Certificate of Free Sale’ form has six sections. The applicant must fill in all the sections unless instructed differently. The sections of the form are as follows:
Section A: Application details
Section B: Identification of the manufacturer
Section C: Identification of the authorised representative
Section D: Service required (fast track service is no longer available so only standard service is applicable at this time)
Section E: Certificate details
Section F: Device details

Application form for Certificates of Free Sale for Medical Devices has been attached.

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The aim of providing scientific or regulatory advice relating to GXP activities is to:
(i) Assist potential applicants for GXP authorisations/registrations to understand the requirements that must be fulfilled in order to be compliant. This can include review of plans for new manufacturing or wholesale facilities.
(i) Assist existing authorisation holders, registrants and stakeholders to understand the requirements that must be fulfilled in order to be compliant. Advice will also be provided, on request, to existing authorisation holders that are, for example, considering expansion or alteration of premises, installation of new or revised processes, etc.

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This document aims to specify the obligations for distributors as outlined in the Regulations, along with supplementary guidance and frameworks that can be used by distributors to meet those obligations. In addition, it sets out the HPRA’s recommendations for good distribution practices. A distributor may have alternative methods for achieving compliance with the regulations and, if justified, these alternatives may be equally acceptable.

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Below listed chapters are included in this guideline:

  1. Authorisation or registration of medicines
  2. Clinical trial authorisations
  3. Manufacturers’/Importers’ authorisations and wholesale distributor authorisations
  4. Blood and tissue establishments and organ authorisations
  5. Exempt medicinal products
  6. Cosmetics
  7. Precursor chemicals
  8. Medical devices
  9. Miscellaneous fees

Note: Fee Application Form for Human Products has been attached.

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The purpose of the guideline is to clarify the criteria for qualification of software and apps as medical devices and to highlight the legislative requirements that medical device manufacturers must fulfil.

The purpose of a device is determined by the manufacturer and not by virtue of how it is applied by the users. For example, an app intended to monitor the heart rate during exercise does not qualify as a medical device, not even if the user chooses to use the app for a medical purpose. In other words, it is the manufacturer who describes what the software/app is intended to be used for.

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This guidance is aimed at consumers who use health apps and software that are medical devices. It offers guidance on how to tell if a health app is a medical device and how you should go about them.

There has been a large increase in the development of health apps for consumers and patient groups with all sorts of purposes and functionality. The purpose of an app could, for example, be to serve as an aid to monitor disease, health, exercise, lifestyle etc. The vast majority in this group of health apps are not medical devices and therefore are not CE marked.

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This guideline describes the following points;

  • Manufacturers
  • Micro and small manufacturers
  • Authorised representatives
  • Roles and responsibilities of the person responsible for regulatory compliance within a manufacturer (paragraph 3)

 

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The MDR has changed the scope of the medical device legislation and it now extends its application to all economic operators in the supply chain (manufacturer, authorised representative, importer and distributor) as well as a broadened range of products such as those specifically intended for the cleaning, disinfection or sterilization of devices (Article 2 (1)) and products without an intended medical purpose (such as certain aesthetic products, as indicated in Annex XVI of the MDR). In addition, more emphasis is placed on a life-cycle approach to safety, backed up by clinical data and new requirements such as transparency and traceability.

 

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Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish the requirements for sampling of Class IIa / Class IIb and Class B / Class C devices for the assessment of the technical documentation.

This guideline describes the following points;

  • Definitions
  • Sampling criteria
  • Assessment of the technical documentation
  • Drawing up and keeping up to date a sampling plan

 

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