Manufacturing and selling of medical devices is one of the most crucial businesses in the world as the importance of producing life-saving equipment can’t be neglected.
To minimize the risk of coming across with scandals such as PIP scandal, the EU has improved and upgraded its laws and regulations from MDD to MDR. The new laws define some conditions which are needed to be implemented with different classes of medical devices (as defined by EU MDR) in order to conform to the new requirements. Although the enforcement has been extended for 2021, but its high time for companies to comply and prepare for the new requirements.
Class 1 Medical Device
According to EU MDR, class 1 medical devices are those which are non-invasive and do not pose serious risks to patient’s health. They are
further divided into two sub-categories i.e. Class I(s), where “s” stands for sterile (they are delivered sterile) and class I (m), where “m” stands for measurement (these devices are used for measuring weight, temperature etc.
Examples of Class I (s) medical devices are: Hospital beds, Bed pen etc.
Examples of Class I (m) medical devices are: Thermometer, weighing scales etc.
The new regulations demand some strict measures regarding GAP analysis in order to manufacture medical devices (Class I medical devices in the context of this document) compliant with the new regulations.
New EU MDR and Gap Analysis
Gap analysis, also referred as needs analysis, is conducted by an organization to compare its current performance with its intended performance. It is a crucial part of business requirements management and is performed in four steps of careful planning about outcomes and gap analysis, collection of current data, analysis of current data versus requirements and formation of a comprehensive report. The report tells what an organization should do for compliance of Class 1 medical devices for EU MDR. .
The recent changes made in EU MDR were supposed to be implemented from May 2020 but due to recent outbreak of COVID-19 pandemic, the implementation process has been delayed till May 2021.
If you are a manufacturer or supplier of Class I medical devices, you may want to make yourself compliant with the new regulations and for that, you will need to have some expert guidance and support.
WHY TS Q & E?
We, at TS Q & E, have been working in this field of regulatory compliance, business management, and auditing and ISO standards implementation in the medical devices sector for more than 10 years. We have a highly capable and skillful team of consultants and engineers; which have assisted our valued customers in completing having comprehensive gap analysis for class 1 devices and several other work areas regarding business management.
We shall undoubtedly provide you with the best experience in upgrading your Class 1 medical device as per the new EU MDR regulations and trust us, you won’t be disappointed! Contact us for the free quote.