The medical device market is governed by its own strict rules. When thinking about putting new products into the hands of users, we have to face more than just competitive challenges. Our main task is to reconcile new ideas and design solutions with current regulations. By conscientiously fulfilling this task, we ensure that our products fully meet our customers’ expectations and are safe for their use.
The principles according to which the medical device market operates are based on Polish legislation (Act of 20 May 2010 on medical devices as amended and others) as well as on EU law (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). Mywam Sp. J.’s special purpose strollers belong to Class I medical devices and are therefore also subject to them.
The above-mentioned legal framework imposes a number of obligations on manufacturers of Class I medical devices, including the need to have the ISO 13485 system implemented in the company (Medical Devices – Quality Management System) and that the manufactured product complies with specified safety standards and has been appropriately notified to an authorised institution (in Poland, such a function is performed by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products).
FIRST THINGS FIRST…
The entire process of manufacturing our products begins in the R&D department, during the design process. The ideas for a new product correspond to market demand, which we confront with scientific knowledge and practical experience to ensure that the product meets the requirements for functionality in everyday life and during daily rehabilitation. To ensure the safety of the product, a risk analysis is carried out as early as when the sketch is created and at every subsequent stage to assess the safety of the product. Once the complete technical documentation has been prepared, a prototype is created and subjected to a series of tests – on the basis of which the product risk analysis is repeated. Once a positive opinion is obtained, the prototype is subjected to strictly defined external tests resulting from harmonised standards to which medical devices, including our special purpose strollers, are subjected. The tests are carried out in specialised laboratories and their results confirm conformity with the required directives and standards.
Once the Laboratory has carried out all the tests of the prototype and completed them with a positive result, a Certificate of Conformity is issued, which is regularly updated on the basis of periodic tests of the product. In addition, the manufacturer issues an EC Declaration of Conformity document, which is confirmation that all the required tests have been carried out and that the product has been adapted to the legislative framework.
NEXT STEPS
An important part of the development process for a new product is the production of an instruction manual. It is an essential document, through which the user should find out, among other things, what the product is intended for, for whom it is intended, how it is designed, how it should be used correctly, what adjustment options it has, what safety rules apply to its use, how it should be serviced and how it should be serviced periodically, as well as information on authorised service centres, disposal methods and warranty conditions. Therefore, it is important for the users to familiarise themselves with the instruction manual so that they are able to keep the product in good working order, which will result in safe use for years to come. In addition, the user manual provides relevant information on how to contact the manufacturer.
Equally important is the correct labelling of the product. On the so-called nameplate one can find information on: the name of the product, the model, the name of the manufacturer, the mark of conformity according to the relevant European regulations and directives, the permissible total weight of the user, the warning to follow the instructions for use and maintenance of the product, as well as the serial number and the date of manufacture. The most important data for the manufacturer, should the user report any defects in the product, is the production date and batch number. It is with these that the manufacturer is able to identify a specific product from a specific production batch.
Once the relevant documentation has been collected, notification of the medical device is made to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. It is not necessary to obtain confirmation of the above notification, but our products also have a Certificate of Free Sale, which serves as a certificate that the product is/can be marketed in the country on the date of issue.
THERE’S MORE
By completing the above formalities, a safe product can be brought to market. However, the process of improving the product in terms of functionality and safety does not end there. The product on the market is constantly monitored in terms of quality. We listen to and analyse the needs of our customers in order to expand our knowledge and improve our products on the basis of real user experiences.
We invite you to read the product documentation, i.e. the Certificate of Conformity, the EC Declaration of Conformity, the User Manual and the Free Sale Certificate available under: Products / MyWam strollers / (selected stroller) / download.
With your opinion on new and long-standing MyWam products in mind, we encourage you to contact us by email at marketing@mywam.pl. We look forward to hearing your opinions and suggestions so that we can improve the products together.