In 2018, ISO published the third edition of the standard on quality plans, ISO 10005:2018 Quality Management – Guidelines for quality plans. The new standard has the following major sections:
Using a quality plan
Development of a quality plan
Content of the quality plan
Operation and control of the quality plan
It also has two useful annexes:
Annex A Examples of formats for quality plans
The examples are:
A “text” type of quality plan
A “table” type of quality plan
A “Flow chart” type of quality plan
Annex B Schematic representation of a process approach applied to quality plans
This includes a diagram that is a variation of the SIPOC diagram.
In 2018 the current version of the EMC Directive, 2014/30/EU, replaced the original version, 2004/108/EC. On July 13, 2018 the EU issued a list of harmonized standards to the current version. See https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/electromagnetic-compatibility_en
The standards bodies are CEN (http://www.cen.eu), CENELEC (http://www.cenelec.eu), and ETSI (http://www.etsi.eu).
ISO has issued ISO 19011:2018 Guidelines for Auditing Management Systems. The standard provides guidance on auditing management systems in general. It does not focus on any particular management system, meaning it could equally apply to ISO 13485:2016 or FDA’s QSR. The standard’s guidance on auditing management systems includes:
- The principles of auditing
- Managing an audit program
- Conducting management system audits
- Evaluating competence of people involved in the audit program
In Spring 2018, FDA announced it intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016.
At a recent MDSAP meeting FDA provided an update on its intention.
FDA estimates it will issue the proposed rule in the Fall 2019.
FDA recognizes the significant impact for implementation. For example:
- Training on ISO 13485 requirements, interpretation, best practices, etc. to CDRH staff and ORA investigators and compliance officers
- Changes to the inspection model (QSIT)
- Revisions/updates to numerous documents
- Changes to IT systems
FDA suggests the transition period will likely be a few years.
The Ombu library, in the Data Analysis aisle, has an article about determining the sample size when each item is either conforming or nonconforming. The article explains the use of the binomial distribution. It also covers the special case of the sample size when based on a confidence level and process nonconformance rate.
The new regulations in the EU, MDR & IVDR, implement a system for Unique Device Identification, UDI. Initially, the regulations provided information on the UDI for labels as well as the core database elements. Subsequently, more information is available. This new information provides the details for a device manufacturer to collect the necessary information in preparation for loading it to Eudamed when it becomes available.
The relevant documents are:
MDCG 2018-1 Draft guidance on BASIC UDI-DI and changes to UDI-DI
MDCG 2018-2 Future EU medical device nomenclature – Description of requirements
MDCG 2018-3 Guidance on UDI for systems and procedure packs
MDCG 2018-4 Annex: UDI database – Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs
MDCG 2018-5 UDI Assignment to Medical Device Software
MDCG 2018-6 Clarifications of UDI related responsibilities in relation to Article 16 of the Medical Device Regulation (EU) 2017/745 and the In-Vitro Diagnostic Medical Device Regulation (EU) 2017/746
MDCG 2018-7 Provisional considerations regarding language issues associated with the UDI database
UDIWG 2018-1 UDI Database, Definitions/Descriptions, and formats of the UDI core elements
UDIWG 2018-2 The architecture of the UDI database – Basic UDI-DI and UDI-DI attributes for Medical devices and In-vitro diagnostic medical devices
Because the documents are not all in one place, use a Google search to find them.
In an update to the list of recognized standards (Recognition List #49) FDA-CDRH consolidated many listings under one number when the standards are equivalent. For example, ISO 14971:2007 and ANSI AAMI ISO 14971:2007/(R)2010 both have recognition Number 5-40.
In addition, the recognition list changes the status of some standards. Among those in the 10993 family are:
Withdrawn – ANSI/AAMI/ISO 10993-4:2002/(R) 2013 & A1:2006/(R)2013 Biological evaluation of medical devices—Part 4: Selection of tests for interaction with blood [Including AMENDMENT 1 (2006)]
Withdrawn – ANSI/AAMI/ISO 10993-6:2007/(R)2014 Biological evaluation of medical devices—Part 6: Tests for local effects after implantation
Withdrawn and replaced with newer version – ISO 10993-16 Third edition 2017-05 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
Withdrawn – ANSI/AAMI/ISO 10993-16:2010/(R)2014 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables from medical devices
The list does not have any new entries in the Quality Systems/Risk Management (QS/RM) or Electrical Safety/Electromagnetic Compatibility (ES/EMC) categories.
Recognition List #49 is available at https://www.federalregister.gov/documents/2018/06/07/2018-12222/food-and-drug-administration-modernization-act-of-1997-modifications-to-the-list-of-recognized
The Notified Body Operations Group, NBOG, issued a list of codes for the Notified Body’s scope of designation.
There is one set of codes for the MDR, NBOG F 2017-3, and another set of codes for the IVDR, NBOG F 2017-4.
The MDR codes, for example, fall into two major groups
- Codes Reflecting the Design and Intended Purpose of the Device
- Horizontal Codes
The codes in the first group also include the MDR annexes for conformity assessment. For example, assume a Notified Body wants to be designated for non-active vascular implants delivered sterile under Annex IX. For the first group, the NB would select code MDN 1103 and check the box for Annex IX. For the second group the NB would select MDS 1005 for devices in a sterile condition.
The NB can select as many codes as apply.
Device manufacturers should determine the codes that apply to their devices and verify that the prospective NB has applied for those designations.
The codes lists are available from https://www.nbog.eu/nbog-documents
Device manufactures who market in Canada should submit a valid MDSAP certificate to Health Canada by December 31, 2018. Some manufacturers face challenges scheduling an MDSAP audit in 2018 and delay in obtaining a certificate from the Auditing Organization, AO.
Health Canada will exercise enforcement discretion for those manufacturers who can demonstrate they have undergone an MDSAP audit in 2018, but do not yet have a certificate.
The announcement is available from https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/transition-medical-device-single-audit-program/certification-cycle-notice.html