Techical Document
The general safety and performance requirements (GSPR) are mandatory under the European Union medical device regulation (EU MDR). Every medical device must meet the relevant requirements listed in Annex I. For each requirement, you must either demonstrate compliance with evidence or provide a scientific justification for why it does not apply to your device.
General Safety and Performance Requirements and Medical Device Risk Management
Navigating medical device risk management requires setting up a continuous process across the whole lifecycle. The regulation says you need a documented plan for every individual device where you identify known hazards and look at risks from normal use and foreseeable misuse. The risk management report should record these hazards and the controls selected for them. There is a strict priority for handling risks. First, you have to design and make the device safe from the start. If you cannot do that fully, you must add protections, and only after that can you use warnings or user training. You also have to keep checking production data and post-market surveillance to update your risk steps. Devices have to perform as the manufacturer intends without harming patients, while keeping the benefit-risk ratio aligned with the state of the art. For non-medical products under Annex XVI, you have to prove there is no risk or that the risk matches the maximum acceptable safety limit.
Risk Management Report and Lifecycle Updates
The risk management report must be reviewed as new production and post-market information becomes available. This review supports medical device risk management throughout the device lifecycle, and medical device regulatory consulting services may be used to identify documentation gaps before submission.
This risk management report should record new hazards, changes in risk estimates, the effectiveness of controls, and any further action required after market release.
Chemical, Physical, Biological, and Environmental Design
When you design the device, you have to look closely at toxicity, flammability, and biological compatibility with human tissues, including how the body absorbs, distributes, metabolizes, and excretes substances through ADME profiles. If your product has several parts that go inside the body, you have to check the properties of your design. These properties include strength, ductility, fracture resistance, wear, and fatigue resistance. You should use data validated through methods or modelling to support accuracy. The design should reduce contaminants, residues, and tiny particles or nanomaterials being released. The device needs to remain stable for its expected life and should be able to handle changes during transport and storage.
Regulated Substances Under the European Union Medical Device Regulation
Invasive devices that contact the body or handle liquids and gases fall under strict material rules. The European Union medical device regulation states that, under Section 10.4.1, they cannot contain Category 1A or 1B CMR substances or endocrine disruptors over a concentration of 0.1% weight by weight.
If you go over this 0.1% limit, you must provide a detailed justification including exposure estimates, alternative material analysis, and evidence that a substitute would affect the performance of the device. This must specifically consider risks for vulnerable groups such as children or pregnant and breastfeeding women. Phthalate guidelines are updated at least every five years, and if these materials are present over the limit, you have to label them on the device packaging and list the risks in your instructions for use.
Infection Control and Biological Materials
Manufacturing controls must reduce risks from needle sticks, support proper handling, and prevent microbial leakage or fluid contamination. Reusable products need to be designed for safe cleaning, disinfection, and re-sterilization. Sterile items must use validated processing methods in controlled rooms so the sterile barrier remains clear and safe until use. Substance-based devices introduced into the body have to verify safety and ADME profiles by referring to Annex I to Directive 2001/83/EC. For non-viable human tissues, obtaining and testing must follow Directive 2004/23/EC, and traceability must match Directive 2002/98/EC. Non-viable animal tissues require validated viral inactivation, veterinary controls, and compliance with Regulation No 722/2012.
Construction, Environment, and Special Device Functions
Connections handled by users must be designed so misconnections are physically impossible. Devices must resist external environmental issues such as magnetic fields, electromagnetic effects, electrostatic discharge, pressure, humidity, temperature, and radio signals. Fire and explosion risks during single-fault conditions must be minimized. If the device has diagnostic or measuring functions, Section 15 says you must state the accuracy limits and use legal measurement units conforming to Council Directive 80/181/EEC.
General Safety and Performance Requirements for Radiation, Electrical, and Mechanical Risks
Radiation exposure must be as low as possible for the clinical target. Intentional radiation systems must give users clear emission controls, reproducible parameters, visual or audible alerts, and follow Directive 2013/59/Euratom. Software and programmable systems must follow lifecycle, verification, validation, and security rules. Active devices need power indicators, failure alarms, and protection against electric shocks. Active implants must have a clear identification code that can be read without surgery. Mechanical designs must prevent instability, noise, and vibration, while devices intended for lay users need built-in validation steps to warn them if a result is invalid.
Technical File Medical Device and Labeling Mandates
Safety data in the technical file medical device documentation must stay updated on your website. The European Union medical device regulation allows labels to use barcodes or RFID, but they must remain human-readable. They must show manufacturer details, Authorized Representative information for non-EU firms, lot or serial numbers, UDI carriers, and single-use or reprocessing limits. Physical IFUs are required unless the device is Class I or IIa and can be used safely without instructions. Electronic IFUs must meet Regulation No 207/2012. Instructions must give clinical benefits, link to the Article 32 Summary of Safety and Clinical Performance, and require serious incidents to be reported. These general safety and performance requirements also require compliance based on expert panel data under Article 106 MDR to record document IDs, versions, and full or partial compliance status. The technical file medical device record should contain the related evidence and cross-references.
Medical Device Regulatory Consulting Services from Morulaa
Need help with GSPR compliance? Morulaa provides medical device regulatory consulting services from file preparation to Notified Body submission. We map your data to EU MDR requirements, support medical device risk management, and review the technical file medical device documentation to identify gaps early.
Contact Morulaa today for medical device regulatory consulting services that support CE marking and market access for your medical device.
Frequently Asked Questions
What happens if you go over the chemical limit for CMR or endocrine disruptors?
Under Section 10.4.1, you cannot go over 0.1% weight by weight. If you do, you must provide a detailed justification showing exposure estimates and alternative material analysis proving that a substitute would affect device performance. You must also place a label on the device packaging, and the risks must be listed in the instructions for use.
How do you need to update phthalate safety guidelines?
The benefit-risk assessments for phthalates that belong to CMR or endocrine-disrupting groups must consider how they are used and what alternatives are available. The guidelines also need to be updated every five years.
Do you always need to include physical instructions for use in a document?
Physical IFUs are required when the device needs them for safety, but Class I and Class IIa devices may not need them if they can be used safely without instructions. Electronic formats are only allowed under Regulation No 207/2012.
What specific logs do you need to keep for expert panel data under Article 106 MDR?
You must log the document identification number and title, the version or year, the compliance status marked as full or partial, and a full description of deviations and alternative solutions used to meet the requirements.
What are the labeling rules if you sell the same device in sterile and non-sterile forms?
The labeling must clearly distinguish between identical or similar devices sold in sterile and non-sterile conditions, and you have to use the standard sterile symbol.
Who do users or patients report serious incidents to if something goes wrong?
The instructions for use must feature a clear notice requiring users and patients to report any serious incident directly to the manufacturer and the competent authority of the member state.