EU Regulations: Things Still to be known

Medical Device Regulations (EU) 2017/745 is an advancement that would help EU in coping with medical science changes. Manufacturers will regard the new regulations as a benchmark globally as it would be transparent, sustainable and will ensure clinical safety thereby leading both healthcare professionals and manufacturers to have equal access to market. The application of EU MDR has been postponed to May 2021. If you want to get registered under the new regulation, 26 May 2021 is when the transition will begin. Take full advantage of this delay is organizing yourself with all the application details. Manufacturers, distributors, and even those in procurement are being equally benefitted from this delay.

Medical Device Regulatory Requirements:

Some common medical device regulations have remained prevalent from the inception of this new regulation. First among them is for manufacturers to get their medical devices CE marked once again under EU MDR. MDR is more stringent as compared to MDD and it tries to ensure safety all through the product lifecycle. The new regulations will be providing ample time to ensure a smoother transition. Several supportive links are present within the EU website to guide manufacturers in abiding by the new regulations.

Distributors, authorized representatives, and importers too have a set of roles to play in this new regulation. They have an active place in the post-marketing part to keep proper vigilance through post-marketing surveillance. Another new concept that is being introduced to facilitate traceability is the unique device identifier (UDI) system. There is a thing of special mention and it is EUDAMED. This database has been designed in such a way that people can access basic data and even tracking and reporting of incidents would be made easier through this.

Healthcare professionals need to understand the difference between MDD and MDR as the new regulation is far stricter. They need to maintain a backup for all the clinical data to ensure safety all through the product life cycle. The Co-existence of devices certified under MDD and MDR within the EU market will continue until 2025.

Annex XVI of the new regulation contains a list of devices that do not possess an intended medical purpose. The manufacturers of such devices need to be dependent on the decision of the commission. It will come from time to time based on the nature and safety of such devices. In case of devices serving both a medical and a non-medical purpose need to fulfil the regulations laid down for both.