ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories replaces the 2005 version.

The more significant changes include:

• A revised scope to cover all laboratory activities including testing, calibration, and their associated sampling
• A new structure that matches other conformity assessment standards
• A process approach that matches newer standards such as ISO 9001:2015
• A stronger focus on information technology that recognizes that hard copy documents are being phased out
• A new section risk-based thinking
• Updated terminology

The new version was published at the end of November 2017. The International Accreditation Service, IAS, published a transition timeline that says all labs must conform to the new standard by Dec. 1, 2020.

FDA has released eSubmitter Version 3. This software allows the user to create reposts, such as MRD or Corrections & Removals, and format them for transmission to FDA Electronic Gateway.

The plan is to allow use of eSubmitter Version 2 until May 2018, when it will be disabled.

Ombu recommends immediate update to Version 3 to ensure all the manufacturers’ internal processes are updated and working before the end of Version 2.

The Ombu Library, in the ISO 13485:2016 aisle, has an article on the Medical Device File from clause 4.2.3. The article explains the files requirements and includes the referenced MDSAP audit tasks and how the medical device File relates to the requirements in the MDD Annex II.

In a bill signed into law on January 22, 2018, the Medical Device Excise tax is suspended for two years, until January 1, 2020.

In an October 31, 2017 notice, Health Canada that says the MDSAP Consortium has implemented changes to reduce the audit time. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/single-audit-program-reduction-audit-times.html

The changes include:

• Streamlined the MDSAP audit approach in the revised version of the audit model. This has reduced the total number of tasks to be accomplished and reduced the overall audit time
• Introduced a 10% reduction in audit time for manufacturers with 45 or fewer employees
• Introduced a 20% reduction in audit time for manufacturers with 15 or fewer employees
• Introduced a 20% reduction in the duration of surveillance and re-certification audits for all manufacturers
• Clarified the expectations for annual surveillance audits with the goal of reducing the audit time.

The Ombu Library, in the MDSAP aisle, has an article that explains the audit duration calculation for an MDSAP audit.

For an audit, the Auditing Organization determines the processes and audit tasks to include. MDSAP provides an Excel workbook that includes the standard time for each audit task and a place to record the included tasks. The workbook calculates the audit duration. The calculation model includes provisions for adjustments such a reduction in audit time for fewer than 45 employees or an increase in audit time to evaluate a correction or corrective action from a previous audit nonconformance.

The EU has updated the list of standards harmonized to MDD. The list, published on November 17, 2017, is available at http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/index_en.htm

The list includes EN ISO 13485:2016 and EN ISO 13485:2016/AC:2016. The presumption of conformity to EN ISO 13485:2012 ends on March 31, 2019. Accompanying note says, “The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation”.