Continuing the blog posts with regard to the implementation of the European MDR (2017/745), the following article puts a focus on the requirements for audits (surveillance and unannounced) and also shows the links to the MDSAP program.
The MDR regulations published in 2017, prescribe in part, under section 4.5.2(b) of Annex VII,

“Based on the audit program it has drawn up, the notified body shall, in accordance with its documented procedures:

– audit the manufacturer’s quality management system***
– based on relevant technical documentation***review and audit***in particular for:
– design and development,
– production and process controls,
– product documentation,
– purchasing controls including verification of purchased devices,
– corrective and preventive actions, including for post-market surveillance, and
– PMCF,”

If your organization operates on the intention to move to the MDSAP (Medical Device Single Audit Program) program, your operation should be ready to adhere to all applicable requirements set forth by European, US, Canadian, Brazilian, Australian and Japanese authorities.

With regard to the US, the FDA intends to harmonize and modernize the Quality System regulation (QSR; 21 CFR Part 820) 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. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation.”

This enables the task of complying with all these different organizations regulations to be less daunting. It enables organizations to anticipate meeting most of their relevant requirements by harmonizing their internal Quality Management System to ISO 13485. By implementing ISO 13485, we are in essence unboxing and jump starting a quality & compliance engine intended to run and control the company’s processes.

To accommodate the needs and activities associated with audits, inspections, research, product development, production, operations, quickly becomes very complicated. To ensure compliance, requires dedicated teams and sufficient resources to ensure the regulatory and quality requirements have been achieved. This should, in part, ensure sufficient personnel are in place and ready for unannounced audits. In this perpetual endeavor, it is critical that your organization dedicates adequate resources to the checks and balances within your QMS processes by performing internal audits and mock inspections. These exercises, of which internal audits are a regulatory requirement, are intended to test case your cGMP and QMS controlled processes to ensure they stand up to their associated regulatory requirements. With regulatory agencies strengthening their own key performance monitoring tools, IE performance reporting databases and harmonization of information through jurisdictional cooperation, unannounced inspections and other post market surveillance techniques will be implemented which manufacturers should ready for.

Section 4.10 of Annex VII of the MDR regulations prescribes in part,

“The notified body shall have documented procedures

defining how and when surveillance activities of manufacturers are to be conducted. Those procedures shall include arrangements for unannounced on-site audits of manufacturers and, where applicable, subcontractors and suppliers carrying out product tests and the monitoring of compliance***

perform extraordinary surveillance measures, such as document reviews, short-notice or unannounced audits and product testing, where it is likely that the certification granted is at risk,

increase the frequency of surveillance audits,

review specific products or processes***

In relation to surveillance audits of manufacturers***

conduct surveillance audits of the manufacturer on at least an annual basis***

ensure that the manufacturer complies with***obligations laid down in relevant Annexes***in the implementation of quality management systems”

Section 3 of Chapter 1 of Annex IX of the MDR reads in part,

“Notified bodies shall periodically, at least once every 12 months, carry out appropriate audits and assessments to make sure that the manufacturer in question applies the approved quality management system and the post-market surveillance plan.***

The notified body shall randomly perform at least once every five years unannounced audits on the site of the manufacturer ***. The notified body shall establish a plan for such unannounced on-site audits but shall not disclose it to the manufacturer***

Within the context of such unannounced on-site audits, the notified body shall test an adequate sample of the devices produced or an adequate sample from the manufacturing process to verify that the manufactured device is in conformity with the technical documentation”.

To achieve the expectations of regulators, it is essential the organization has installed systems which continually monitor and steer processes into complying with defined specifications. For technical documentation, the MDR defines in part in Annex II,

“The technical documentation***shall include***

Device description and specification***

Reference to previous and similar generations of the device***

A complete set of:

the label or labels on the device and on its packaging***

the instructions for use***

Design and manufacturing information***

General Safety and Performance Requirements (referencing to Annex I of the MDR)***

Benefit-risk analysis and risk management***

Product verification and validation*** including:

pre-clinical and clinical data

additional information required in specific cases”

The rate in which your product will be scrutinized by regulators will be greatly dependent on the risk associated with the use of your products, and post market surveillance performance of your products. Periodic assessments, such as mock inspections and internal audits, are intended to ensure your organization is in good standing with worldwide regulations. Please visit our website’s sectionon auditing and training and download the associated presentation by Frank Blömer which further elaborates on the topic of unannounced inspections.

by Adam Freeman, Senior Consultant, confinis ag