Annex I under the EU MDR, General Safety and Performance Requirements, outlines some broad requirements that are applicable to all devices. Manufacturers need to carefully read and understand each requirement since only some of them will apply to any given device.1
Under Annex I, there are 3 major chapters:
- General Requirements
- Requirements regarding design and manufacture
- Requirements regarding the information supplied with the device
This section details the risk management activities as it pertains to the European requirements. As it is known, ISO 14971 is the gold standard for risk management for medical devices. The EU has additional requirements which are outlined in Annex Z of the ISO 14971:2012 version. To read more about the European requirements for Risk Management, read our blog here EN ISO 14971:2012 differs from ISO 14971:2007 read our blog APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES IN THE EU.
Requirements regarding Design and Manufacture:
This section outlines the various testing or special requirements that manufacturers need to follow for the following attributes if present in their medical device:2
- 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 or of combinations of substances 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 or measuring function
- Protection against radiation
- Electronic programmable systems – devices that incorporate electronically 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 supplied energy or substances
- Protection against the risks posed by medical devices intended by the manufacturer for use by laypersons.
Requirements regarding the information supplied with the Device:
This section covers requirements that apply to the IFUs and labels of the medical device:2
- Information on the label
- Information on the sterile packaging
- Information in the instructions for use
It requires manufacturers to give consideration to the education, knowledge, training, the use environment of the device and the intended use of the device and to inform the users of any residual risks.
Interpreting the requirements and determining which requirements apply to your product can be confusing. Reach out to us at 248-987-4497 or email us at firstname.lastname@example.org to learn more.
1Ombu Enterprises LLC- General Safety and Performance Requirements retrieved on 2/11/2020 from http://dev.ombuenterprises.com/wp-content/uploads/2019/03/EU-MDR_General_Safety_and_Performance.pdf
2European Commission (April 2017) REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC retrieved on 2/11/2020 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN