Medical Device Regulation (MDR)- Everything You Need to Know

Whitepaper | June, 2021

The Medical Device Directive, better known as ‘MDD’ and officially termed as Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12 was intended to harmonise the laws relating to medical devices. The directive has served the healthcare and medical device industry for ages in bringing out the safest medical devices into the market. But lately, ‘a need’ was felt for further clarity on technical issues (such as safety, traceability, classification rule, software, clinical evidences, surveillance, vigilance, promoting innovative devices) and transparency due to which European Commission (EC) has put into so much of effort to make the MDR applied today. Indeed, MDD had great contribution to the evolution of the current Medical Device Regulation because it’s the various scope of improvement within the MDD, that has necessitated a directive to be reckoned to bring in as ‘a new regulation’ to ensure the highest standard of safety and quality for medical devices that are produced in EU or Non-EU region, or imported and distributed to the member countries of the European Union (EU).

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