Our July MedTech news covers the latest from the EU commission on harmonised standards under MDR, FDA’s recent efforts to improve cybersecurity, the latest medical devices to have their UPHN status removed in Canada, and a Q&A from the MDCG on EUDAMED actor registration.
Read on for more on the above, plus UDI guidance from the US and EU, and EMA’s updated guideline for medicinal products used with medical devices.
EU commission implementing decision on harmonised standards under MDR
On 19 July 2021, the European Commission issued an implementing decision in the Official Journal of the EU on the harmonised standards for medical devices in support of Regulation (EU) 2017/745.
The decision officially recognises the following standards as harmonised standards under MDR:
- EN ISO 10993-23:2021 | Biological evaluation of medical devices – Part 23: Tests for irritation
- EN ISO 11135:2014 | Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices
- EN ISO 11137-1:2015 | Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- EN ISO 11737-2: 2020 | Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- EN ISO 25424: 2019 | Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices
FDA aims to improve cybersecurity through medical device servicing
The FDA’s Centre for Devices and Radiological Health (CDRH) has developed a discussion paper that aims to improve cybersecurity by addressing the servicing of medical devices.
“Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities” identifies four areas including; privileged access, identification of cybersecurity vulnerabilities and incidents, prevention and mitigation of cybersecurity vulnerabilities, and product lifecycle challenges and opportunities. The paper is available here, and open for comments until 22 September, 2021.
Should you be interested in more cybersecurity news, our recent article on what Biden’s executive order means for medical device cybersecurity is available here.
Health Canada lists medical devices with removed UPHN status
To determine if there’s an urgent public health need (UPHN) for a medical device, Health Canada considers various factors including the device’s supply and demand, lifecycle, and clinical need, plus the COVID-19 status in Canada.
As the pandemic evolves, Health Canada is continually assessing whether there’s an urgent public health need for certain categories of medical devices. They have recently published the categories of COVID-19 medical devices that no longer have UPHN status – see here for more details.
MDCG addresses questions on EUDAMED actor registration
The MDCG has published a Questions and Answers on requirements for EUDAMED registration of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 of Regulation (EU) 2017/745 on medical devices (MDR) and/or Article 28 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
The Q&A also clarifies the circumstances for which an Actor ID is issued instead of a single registration number (SRN). Read more here.
FDA shares UDI guidance
The FDA has issued a guidance document to assist with UDI labelling requirements.
The document is intended to help labellers and FDA-accredited issuing agencies comply with unique device identifier (UDI) labelling obligations. The guidance describes requirements and recommendations for the form and content of the UDI, to help ensure that it meets the objectives of the Unique Device Identification System Final Rule, 78 FR 58786 (September 24, 2013). Find out more here.
Integrating UDI within your QMS – guidance from MDCG
MDCG has published a guidance note on the integration of the UDI within an organisation’s quality management system.
The guidance includes considerations for integrating the UDI obligations within the different areas of a QMS covering design and development, product documentation and retention, production and process, serious incidents and field safety corrective actions, purchasing controls, documentation and records, enterprise resource planning and UDI data to be provided to the EUDAMED database. Read the guidance here.
EMA issues quality documentation guideline for medicinal products used with medical devices
Last week EMA issued an updated version of its guideline that describes the information that should be presented in the quality part of a marketing authorisation dossier for a medicinal product when it is used with a medical device.
The guideline focuses on product-specific quality aspects of a medical device that may have an impact on the quality, safety and efficacy of a medicinal product, and will become effective as of 1 January 2022. Find out more here.
That concludes our July MedTech news. Check back in August for more updates.
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