2016 has brought its share of changes and announcements in the applicable regulations and standards. Many actors have already started to perform Gap analysis, build plan, and update their Quality Management System to implement or anticipate these changes.
For our last newsletter of the year, we compiled a summary of those changes, recent and upcoming.
ISO 13485:2016: The evolution of the standard
After the revision of the ISO 9001 standard in 2015, the latest revision of the ISO 13485 standard, Medical devices Quality management systems - Requirements for regulatory purposes, has been published on March 1st, 2016. The new revision of the standard put a strong emphasis on Risk Management and Regulatory Requirements and is applicable to a broader range of actors. This version of the standard indicates indeed all the organizations involved in the medical device life-cycle. This includes Authorized Representative, Distributors, Suppliers, and Importers.
The transitional arrangements defined by the International Standardization Organization (ISO) allotted a 3 years transition period to allow certified companies to absorb the changes while evaluating the gap between the previous version of the standard published in 2003 and their Quality Management Systems and procedures.
On February 28, 2018, all existing ISO 13485:2003 certificates will become obsolete. It is therefore critical for certified companies to understand and plan accordingly their transition towards the new revision to avoid any certification interruption.
Training Announcement on the Evolution of the ISO 13485:2016
February 14th and 15th – California
Whether you are new to the standard or transitioning from the 2003 or: 2012 version of the standard, entrust our training organization to ensure a smooth transition and bring the knowledge of your employees and organization up to speed. Our experts have created a 1 day training course designed to help you understand the Evolution of the ISO 13485:2016 standard
Join Florianne Torset- Bonfillou, Director of Regulatory, Education and Quality at LNE/G-MED North America Inc for training and comprehend the new regulatory requirements and purpose of ISO 13485:2016. Register here!
Medical Device Single Audit Program (MDSAP)
The MDSAP program is reaching the end of its pilot phase at the end of December 2016 and enters its implementation phase. During this past year, the ISO 13485:2016 publication and Health Canada announcement about its licensing requirement have impacted the program.
The MDSAP will integrate the new provisions of ISO 13485:2016 and its status is changing for Canada: Starting January 2019, gaining and maintaining a device license to market class II, III, IV devices will be subject to the certification of the manufacturer according to ISO 13485 within the MDSAP program. The replacement of the CMDCAS program by MDSAP makes the later becomes mandatory for Companies which want to maintain or gain access to the Canadian market. This change requires the impacted companies to plan their transition from their ISO 13485 within the CMDCAS program to the MDSAP program.
To learn more about this program, visit our dedicated MDSAP page or subscribe now to receive our MDSAP newsletter. Sign up today!
MEDDEV 2.7.1 Rev 4 - Clinical Evaluation of the Medical Devices
The new version (Rev.4) of MEDDEV 2.7.1 European guidance on the Clinical Evaluation of medical devices (MD) was published in June 2016. The new revision 4 of 2.7.1 MEDDEV does not fully change the Clinical Evaluation process but includes much more detailed information.
A substantial amount of information was added to the original document, and an extensive portion of the change was dedicated to clarify or rather, specify the requirements for clinical data. However, in the light of the upcoming changes brought in in the new MD regulations, the impact of some changes should not be underestimated.
Many details are provided in the new revision 4 and it is highly recommended that manufacturers perform a gap analysis of their current CER and procedures.The Clinical Evaluation approach requires more than ever a rigorous methodology that can (and should) only be performed by Qualified Persons. It is certainly a very helpful tool in helping to transition to the new regulatory requirements.
Anne Le Rouzo, Certification Project Manager and Lead Auditor at LNE/G-MED North America discuss the changes introduced by the new Revision of the MEDDEV 2.7.1 on Clinical Evaluation. Subscribe now to our newsletter section and access our guides and documentation. Sign up today!
The New MDR and IVDR: moving forward
In June 2015, a new draft of both the Medical Device Regulation and the In Vitro Diagnostic Regulation was published and a final publication is since then expected to be released in May 2017.It is under the Dutch Presidency of the Council and Representatives of the European Parliament that a political agreement was reached on the content of the future Medical Device (MD) and In Vitro Diagnostic (IVD) Regulations.
With a 3 year transition period for the future Medical Device Regulations (MDR) and a 5 year transition period for the In Vitro Diagnostic Regulations (IVDR), the expected impacts on the devices conformity demonstration, and even if not published yet, should see manufacturers start building their transition plan.
To learn more about the New MDR and IVDR, visit our newsletter section and explore the different articles on the Medical Device Reclassification in the Medical Device Regulation Proposal, the Clinical evidence requirements of In vitro Diagnostic Devices in the future EU IVD Regulation and more. Sign up today and receive our regulatory updates directly in your mailbox!
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