In today’s post we’re talking about the General Safety and Performance Requirements (GSPR) under the new European Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). If you are a manufacturer trying to transition to the new MDR 2017/745 or IVDR 2017/746 or even just trying to get a CE mark for the very first time, then being able to show how your device complies to the new General Safety and Performance Requirements is critical.
What is the GSPR?
The GSPR stands for General Safety and Performance Requirements and forms part of Annex I of the new European Medical Device Regulations: MDR 2017/745 and In Vitro Diagnostic Regulations: IVDR 2017/746.
Manufacturers who want to sell their products in Europe with a CE mark affixed to it will have to show that their device complies with these safety and performance requirements together with being able to provide sufficient evidence that shows how device conformity is maintained. Alternatively, if there are certain clauses of the GSPR that are not applicable to the medical device in question, manufacturers will have to then justify why these clauses are not applicable with sufficient reasoning.
How is the General Safety and Performance Requirements different from the Essential Requirements?
The GSPR now replaces the old Essential Requirements which formed part of the MDD 93/42/EEC. The Essential Requirements were previously defined as those requirements that every medical device had to fulfill. These Essential Requirements were described by the old Medical Device Directives: MDD 93/42/EEC and In Vitro Diagnostic Directive: IVDD 98/79/EEC. These Directives are now repealed.
As a start, the GSPR now has 23 requirements under the MDR 2017/745 and 20 requirements under the IVDR 2017/746 which is significantly more requirements than the old Directives.
For indication purposes, the Essential Requirements from the old Directives were broken down as follows:
|EU MDD 93/42/EEC||EU IVDD 98/79/EEC|
|Chapter 1 – General requirements (clause 1 to 6)||Chapter 1 –General requirements (clause 1 to 5)|
|Chapter 2 -Design and Manuf. (from clause 7 to 13)||Chapter 2 -Performance, Design and Manuf. (clause 1 to 8)|
Now let’s break down the GSPR:
The GSPR consists of three chapters under the MDR 2017/745 and IVDR 2017/746:
|Chapter||MDR 2017/745||IVDR 2017/746|
|I||General requirements (Clause 1 – 9)||General requirements (Clause 1 – 8)|
|II||Requirements Regarding Design and Manufacture (Clause 10 – 22)||Requirements Regarding Performance, Design and Manufacture (Clause 9 – 19)|
|III||Requirements Regarding The Information Supplied With The Device (clause 23)||Requirements Regarding Information Supplied With The Device (clause 20)|
From the tables above, we can see that the Essential Requirements are divided into 2 chapters with 13 items while the new Medical Device Regulations and In Vitro Diagnostic Regulations have 3 chapters with 23 items and 20 items respectively. This means that the scope of details in the safety and performance requirements have increased quite a bit.
Furthermore, several new topics are incorporated in the requirements list of the GSPR. These include (but are not limited to):
- Requirements for devices that administer or contain drugs
- Specific requirements for devices that contain tissues of human or animal origin
- Requirements for disposal
- Requirements for IT safety
- Requirements for devices for use by lay persons
- General requirements for labelling
What does each Chapter of the GSPR require?
Chapter 1: General Requirements
Chapter 1 of the GSPR has many similarities with the old Directives however there is now an increased focus on usability, state of the art and risk management.
Chapter I contains general requirements that are applicable to all medical devices and this includes:
- Intended purpose, safety of patients, users and other persons
- Reduction of risks
- Risk management system
- Risk control measures
- Risks related to use error
- Device performance shall not be adversely affected
- Device design, manufacture, packaging
- Risk reduction, acceptable risk-benefit ratio
- General safety requirements for devices without an intended medical purpose as described in in annex XVI
Chapter II: Requirements Regarding Design and Manufacture
Chapter II deals with the chemical, physical and biological properties of the medical device, together with requirements for infection, microbial contamination and related sterility as well as substances, interactions with the environment and mechanical and thermal risks. These requirements include:
- Chemical, physical and biological properties
- Infection and microbial contamination
- Devices incorporating a substance considered to be a medicinal product and devices that are composed of substances/substance combinations that are absorbed by or locally dispersed in the human body
- Devices incorporating materials of biological origin
- Construction of devices and interaction with their environment
- Devices with a diagnostic and measuring function
- Protection against radiation
- Electronic programmable systems – devices that incorporate electronic programmable systems and software that are devices in themselves
- Active devices and devices connected to them
- Particular requirements for active implantable devices
- Protection against mechanical and thermal risks
- Protection against the risks posed to the patient or user by devices supplying energy or substances
- Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons
Chapter III: Label and Instructions For Use
Chapter III deals with the requirements around labelling and instructions for use.
This chapter deals with:
- the format of the instructions for use
- readability of information
- how this relates with laypersons and professionals
- requirements around UDI labeling
- labelling for devices that contain human or animal tissue
- labeling of sterile packaging
- labelling for devices that contain Carcinogenic Mutagenic and toxic to Reproduction (CMR) substances
How to Create and Complete Your GSPR Documentation
Creating the GSPR has been a difficult step for many medical device manufacturers. Having a starting point can really help.
STEP 1: The first step is to determine what your current state of compliance is. If you are an existing CE mark holder, then you will need to transition your Essential Requirements document to a General Safety and Performance Requirements format. On the other hand, if you are applying for a CE mark for the first time, you will need to create a GSPR checklist from scratch.
STEP 2: Next you will need to perform a Gap Assessment. Start by analyzing the checklist clause by clause. If a requirement is applicable to your medical device, then mark it as applicable.
STEP 3: Next assign the relevant standards and evidence. The applicable standards should be mentioned in your GSPR checklist. Any applicable evidence (such as test reports, technical file chapters, procedures) should also be referenced in specific, concrete detail.
STEP 4: The last step is to add a justification for non-applicable clauses. This is crucial because you cannot just identify a clause as being not applicable without stating a reason why, in relation to your device.
Purchase Your GSPR Checklist here.
Creating a GSPR checklist from scratch can be a nightmare because there are so many clauses to analyze, and you need to document applicable evidence for each clause.
To make the process easier, I’ve created a ready-to-edit GSPR checklist. You can purchase it here.