Newsletter No 30 January 2023

Subject: MDR General Safety and Performance Requirements

Back from the well-deserved December break, and as the proposed extension of the MDR[1] transitional period continues its course through public consultations and discussions, we resume the journey towards MDR with an overview of the general safety and performance requirements (GSPR).

What are the GSPR?

The GSPR are a set of product characteristics that the medical devices need to fulfil as a precondition for placing them on the market according to MDR in the European Union.

The GSPR are considered as essential to ensuring that any new device will be safe and perform as intended throughout its shelf life.

GSPR constitute an MDR requirement and replace the former essential requirements (ER) according to the MDD[2].

MDR in article 10 establishes that manufacturers have the obligation to:

• identify applicable GSPR
• explore options to address those requirements according to the intended purpose of the device
• include justification, validation and verification of the solutions adopted to meet those requirements

Methods used to demonstrate conformity may include use of harmonized standards, common specifications or other solutions specifically set for a particular device.

Which range of product characteristics does GSPR cover?

The GSPR are described in Annex I MDR and contain three chapters:

• Chapter I – General requirements

This chapter describes the general requirements to eliminate or reduce risks as much as possible when used according to the intended use and including use error, take protections and inform the users of residual risks.

It also covers eventual adverse affectation of the characteristics and performance during the device lifetime, transport, and storage.

The goal is to assess the benefit-risk balance according to the intended use.

• Chapter II – Requirements regarding design and manufacture

This chapter covers the requirements regarding specific device features including the following:

• chemical, physical and biological properties
• infection and microbial contamination
• devices incorporating a medicinal product or substances absorbed or locally dispersed in the human body
• devices incorporating materials of biological origin
• construction of devices and interaction with their environment
• diagnostic or measuring function
• protection against radiation
• electronic programmable systems and software as medical device
• active devices and devices connected to them
• active implantable devices
• protection mechanical and thermal risks
• devices supplying energy or substances
• intended use by lay persons

• Chapter III – Information supplied with the device

This chapter lists the information supplied by the manufacturer, including information on the label, on the packaging with specific mention to sterile condition of a device, and in the instructions for use.

The information is basically required to identify the medical device and the manufacturer, to provide its traceability, and when applicable, to describe the sterile barrier settlement, transport and storage conditions, instructions for use, warnings and precautions.

This information may be provided in text, including all applicable languages in the countries where the product is being marketed, or in symbols that replace certain information according to harmonized standards.

Which are the obligations of the importers and distributors regarding GSPR?

The obligation to fulfil the GSPR relies on the manufacturer. However, some of the requirements require the participation of the actors in the distribution chain, for example to ensure that:

• while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer. These conditions are typically provided in the information supplied with the device.
• complaints and suspected vigilance cases are notified in a timely manner.

In conclusion

The GSPR are used to summarize in a matrix the requirements applicable to a medical device or the justifications for non-applicability, the methods used to demonstrate compliance, and the traceability to the records proving compliance.

The GSPR checklist completeness are a very important step for medical device manufacturers prior to placing a MDR product on the market. This document is part of the Technical Documentation and is reviewed by the Notified Bodies as part of the MDR certification and/or by National Competent Authorities upon request.

STS Medical Group, as part of the MDR journey, takes this task with responsibility in order to deliver safe supplies to patients and hospitals.

This newsletter is part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the MDR Art.22 “Systems and Procedure Packs”. 

We are already today all dependent on efficient cooperation. For the MDR implementation, we require even closer collaboration to ensure we all can deliver safe supply to hospitals and patients in the future.

We are confident we will continue to supply health care competently on customized surgical procedure sets and small kits.

The next MDR newsletter will be issued in February. We wish everyone productive and pleasant days.

Do you wish to know more about specific MDR topics? Do you have any questions or comments about STS newsletter? Write us at MDR2020@stsmedicalgroup.com.

[1] MDR stands for Regulation (EU) 2017/745 on medical devices.

[2] MDD stands for Council Directive 93/42/EEC regarding medical devices.