Additional Requirements for Manufacture of Medical Devices to be exported to EU. Changes in ISO 13485:2016

European union has changed its regulations with respect to Active Implantable Medical Devices. Medical device manufacturers were following the directive under (MDD) 93/42/EEC to comply with for their implantable devices and for of Active Implantable Medical Devices must follow the Directive detailed in 90/385/EEC (referred to as ‘MDD/AIMDD’)

On 26th May 2017 European Union issued a directive to change this provision. Manufacturers must now comply with Regulation # 2017/745 the Medical Device Regulation (MDR) European Union (EU).  All those manufacturers seeking extension of CE certificate or those desiring to apply for new one or issue of a certificate of compliance for their medical devices must comply with this new regulation. Transition time permitted is up to May 2020. They must transfer all technical documents to the new format. In any case all CE certificates will expire by April 2024 unless they comply with new regulations published as MDR.

ISO 13485 stipulates compliance to regulatory requirement of maintaining Medical Device file (MDF). and Device History file (DHF) refer element 4.2.3 of ISO13485:2016; hither to being maintained by medical device manufacturers. These files are now to be replaced by MDR for all devices needing export to European Union and should contain detailed technical documentation. ISO 13485:2016 does not include this stipulation since the change has taken place in May 2017. All medical device exporters to European Union must take a note of this and initiate compliance activity. These files are to be maintained till the end of life cycle of the device. This change in regulation does not warrant recall of medical devices already manufactured. Transition time is granted till May 2020.

The main idea behind the change is to bring in technical information in to UDI (Unique Device Identification) in order that there is improvement in safety during use.

ISO 13485:2016 implicitly states in section 8.4 a.  that feedback from use of medical device must be used to analyze data and take actions on opportunities for improvement identified through the analysis of data (8.4.c). The new regulation of MDR makes this as an explicit requirement to be incorporated by companies manufacturing active implantable medical devices, exported to European Union, as per element 8.4 in ISO 13485:2016 is that, a Periodic Safety Update Report (PSUR) and a Post Market Surveillance Report is to be obtained for all Active Implantable Medical Devices.

One significant change is regarding Post Market Surveillance in article 86 of the MDR is as follows

manufacturers should play an active role during the post-market phase by systematically and actively gathering information from post-market experience with their devices in order to update their technical documentation and cooperate with the national CA in charge of vigilance and market surveillance activities. To this end, manufacturers should establish a comprehensive post-market surveillance system, set up under their quality management system and based on a PMS plan. Relevant data and information gathered through PMS, as well as lessons learned from any implemented preventive and/or corrective actions, should be used to update any relevant part of the technical documentation, such as those relating to risk assessment and clinical evaluation, and should also serve the purpose of transparency’.  (Source: https://www.medidee.com/wp-content/uploads/2018/05/White_Paper_Technical_Documentation.pdf. Refer MDR section II, IV, Section XIV and Section XV)

“Other Salient points of Changes in MDR are as follows:

  1. Description of the device and specification
  2. Description of Device and design specifications
  3. Data from Preclinical trials and Data from clinical trials
  4. Device safety Report
  5. Risks identified, and mitigation techniques incorporated
  6. Periodic usability safety report (PUSR)
  7. Post Market Surveillance report. (PMS)” (Source: https://www.medidee.com/wp-content/uploads/2018/05/White_Paper_Technical_Documentation.pdf)

Further details can be sought from the white paper by BSI referred above.

How do these changes affect ISO 13485:2016? These changes do not affect the quality management systems developed in ISO 13485:2016 based on ISO 9001:2008.

Changes are affected in the maintenance of Medical Device files hitherto being maintained. These files change according to new stipulations.

ISO 13485:2016 section 8.4 to be interpreted to include Post Market Surveillance (PMS) and Periodic Safety Update for all active implantable medical devices being exported to EU.

AEC Difference: Audit Expertise Comptable LLC is a premium Auditing, Consulting and Training firm involved in coaching, assisting and auditing, facilities to be certified to international standards.  AEC will make sure that all changes to regulatory requirements are communicated to manufacturers during consultation and that documentation change requirements are fully met. Over 25 years the firm has been engaged in this business and has helped over 700 facilities in achieving their certification goals. AEC has a disciplined 10 Step path towards certification which is insensitive to failure. AEC has helped organizations to get certified not only ISO 13485 but also to several other International Standards such as ISO 9001, ISO 14001, ISO 45001 and sector specific standards such as, IATF 16949:2016, AS 9100 D, TL 9000, FSSC 22000:2018, SQF edition 8. BRC-8 IFS in food safety and many more. Please visit our website wwwaeciso.com or contact for immediate assistance on Phone 770-518-9967, e mail: hr@aeciso.com

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