What is MDR
MDR (Medical Device Regulation) finds its predecessor in MDD i.e. Medical Device Directive. The former is quite lengthier and has about five more guidelines attached to it. These guidelines have been updated in order to align the existing safety and precautionary measures with the dynamic environmental changes and the advancement in the field of medical industry. All the medical devices’ safety and security manufactures and distributions across Europe are ensured by MDD. MDD, as is already mentioned, is a revised and updated documentation of rules and regulations listed in MDR guidelines 2017.
The primary reason behind this revision is to ensure that a more sustainable, adaptable and medically dependable framework for medical assessment can be envisaged. In addition to being realistically more dynamic, it is also more robust system of tracking development in the field of drugs and medicines. It would be noteworthy to go through these changes and to see how Surgeine Healthcare follows the changes diligently and carefully.
- There is a greater accentuation on the word “safety” in MDR. In “MDD”, the word appears only for 40 times. This illuminates that there is now a greater focus on safety and Surgeine Healthcare adheres to the same quite cautiously.
- All these changes in MDR have made medical companies rethink the vocabulary they had been using. Surgeine Healthcare had already taken a global assessment of its rationale and had adapted to all the changes suggested by MDR to stay relevant as well as preferable in the industry.
- It is insightful to underline here that all these changes have now made it compulsory for the medical companies to get re-certified by abiding to the standards of new regulations. Surgeine Healthcare has always been known to adhere to the dynamic changes quite rapidly and has gotten all of its services and equipment certified and standardized to ensure complete safety of its clientele.
- The new standards have made it compulsory for all the medical companies to upgrade its data, labeling as well as documentation. MDR is more stringent as compared to MDD on this aspect.
- In order to make the process of distribution of medical drugs and medicines, UDI has been issued by the authority of MDR to all the medical companies. Surgeine Healthcare makes sure that all its products are labeled with this Unique Device Identification.
- It is also interesting to underline here that MDR takes into account AIMD as well as medical purpose devices. Both of these factors were categorically ignored by MDD.
- More extensive focus is to put on labeling in MDR. All the technical, operational as well as surgical equipment need to have these labeling. PRISYM ID Labeling Solutions is being widely accepted in medical domain and Surgeine Healthcare has also adapted to these changes quite mindfully and has labeled all its equipment quite appropriately.
- MDD had only included strictly medical devices within its ambit. MDR, however, includes cosmetic devices such as liposuction equipment and epilation lasers too.
- It also includes all the disinfectant materials with its standardization.
- Greater focus on transparency has also made medical companies more vigilant. Surgeine Healthcare makes sure that all of its equipment goes through elaborate quality check before being transported.
Additionally, it is also important for companies to now report all the serious deterioration not leading to death to EU portals within 15 days. The reporting of information related to safety has always been a priority for Surgeine Healthcare as well.
Surgeine Healthcare only deals with disposable medical equipment. Even MDR suggests reduction of reusable surgical items owing to their highly skeptical composition and higher risk of contamination. It is also worth mentioning that there are now four risk classes in IVDs. This requires Surgeine Healthcare to be more categorical about its reviews.
Since Surgeine Healthcare has always been quite reliable and trustworthy in the way it functions, revision of MDD and its evolution into MDR has made our processes even smoother and effective.