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EU) MDR 2017/745 compliance requirements

The (EU) MDR 2017/745 compliance requirements as they apply to your regulatory role (manufacturer, authorized representative, importer, distributor) are either already applicable, in the case of devices first marketed in the EU or for MDD devices, coming into effect from 26 May 2024.

Manufacturers of components provided into the medical device industry should now take the opportunity to review their current Quality Management System and their regulatory role, where applicable and consider a regulatory strategy going forward.

Please note the following for your attention and action as required:

(EU) MDR 2017/745 (Please refer to relevant MDCG documents for clarification or interpretation where required)

  1. Failure to comply with MDR, including Eudamed (with its changing set of deadlines) and the maintenance of mandatory records, will in future be documented as a finding in our Assessment Reports in the first instance for new medical devices gaining CE marking for the first time in the EU market.  MDD Devices will be bound by these BQAI policy updates from 26 May 2024.
  2. A Major finding will be recorded when MDR obligations are not fulfilled.
  3. Where a noncompliance indicates a significant risk to the patient or end-user safety, a Major finding will be recorded, and the regulatory authority will be advised in writing of the situation.
  4. When a Policy like this is decided upon, it should be communicated to all current clients and included in all future contracts regarding ISO 13485.
  5. Prior to assessment please ensure the following:
      • The Device is classified as per Annex VIII of the MDR
      • The device is eligible to be assessed under the MDR
      • A conformity procedure has been followed and route to conformity justification has been established and documented.
      • The manufacturer has assessed their device against the GSPR’s at Annex I and provided justification against any GSPRs that do not apply.

For legacy devices, there is no requirement to have a PRRC in place until 26 May 2024, at which time your QMS needs to be MDR compliant and, you will therefore require a PRRC as set out in (EU) 2017/745 MDR.

If however, the organization has listed the MDR in the regulations captured in your Quality Manual, they will then be audited to the compliance of the above regulatory requirement.

PRRC Appointment & Role

 Guidance document MDCG 2019-7 addresses the PRRC and requires that a PRRC be appointed with an appointment letter in place.  Qualifications need to align with the requirements of Article 15 of (EU) MDR 2017/745.  It should be noted that:

– For the purpose of fulfilling the requirement laid down in point “a” of Article 15 (1), any qualification acquired outside the EU, including any university diplomas or certificates, should have been recognised by an EU Member State as equivalent to the EU corresponding qualification.

– Professional experience in regulatory affairs or in quality management systems relating to medical devices should be related to the EU regulatory requirements in the field.

You should note that in accordance with Annex IX Section 3.4 to the (EU) MDR 2017/745 there is a mandatory requirement for unannounced audits at least once in every 5 years on the site of the manufacturer, and where appropriate, of the manufacturer’s suppliers and/or subcontractors.

Please be aware that Article 39, in conjunction with Annex VI Part 1 1.4 extends the requirement of the PRRC not only to the Manufacturer, and Authorized Representative, but also when applicable to the importer.

Client Certification Updates

  • Ampersand Health Ltd. have recently been certified to the Medical Device Standard  EN ISO 13485:2016 (ISO 13485:2016) for development and provision of medical device software applications for inflammatory conditions and allied fields.
  • Apparel Supply Ltd have been certified to the Medical Device Standard  EN ISO 13485:2016 for manufacture and distribution of disposable surgical face masks.
  • Aspect Software Ireland Ltd have been certified to the Quality Management System Standard ISO 9001:2015 for planning, order Processing, procurement, manufacture, assembly, and test of Contact Centre Systems and Related Products.
  • CommSec Communications & Security Limited have been certified to the Information Security Management System Standard EN ISO 27001:2017 (ISO 27001:2013) for delivery of managed IT security services and solutions.
  • Glanbia Ireland t/a Glanbia Transport have been certified to the Quality Management System Standard ISO 9001:2015 for the provision of transport of whole milk and milk by-products processed on GII sites including from farm to factory, and from factory to export.
  • Langan Consulting Engineers have been certified to the Quality Management System Standard ISO 9001:2015 for the provision of Civil-Structural Design consultancy engineering services in the structural, earthworks, drainage, geotechnical, water services, utilities infrastructure, marine and flood risk industry sectors.
  • Peppy Health Limited have been certified to the Information Security Management System Standard EN ISO 27001:2017 (ISO 27001:2013) Provision of Healthcare Software and related data collection and processing.
  • Saturn Pass Ltd. have been certified to the Medical Device Standard EN ISO 13485:2016 for development and provision of medical device software applications that are used in conjunction with SARS-CoV-2 test kits.