New Medical Devices Ordinance - What has to be observed?
You are a company in the medtech industry and have been dealing with the new EU regulations for European medical devices for some time? We explain which changes you will have to make and what needs to be taken into account.
At the end of May 2017, the new European Medical Device Regulation (MDR) and the EU Regulation on In-Vitro Diagnostics (IVDR) came into force, replacing the existing directives for medical devices. A transitional period applies to all manufacturers until 26 May 2020. From then on, when a new product is introduced, CE certification in accordance with the new MDR is required. Forward-looking entrepreneurs have had to deal with the new regulations for some time.
The effects of the change are particularly noticeable in the areas of medical technology, where software is important. The new Rule 11 states that developers can no longer document and declare the EU requirements of the international standard IEC 62304 for the life cycle of medical software themselves, but must consult notified bodies. This will present many companies, especially smaller companies and start-ups, with a major challenge.
At a glance: What do the new MDR and IVDR regulations mean?
The new Medical Devices Ordinance is designed to ensure greater safety and faster supply of innovative medical devices to patients. The requirements for new medical devices were tightened, as was the subsequent monitoring of the products on the market. To this end, the rules and regulations have been extended enormously - from 65 pages to 566 pages. For manufacturers this means above all an enormous bureaucratic effort to create new documentation for existing products within the transition period of three years. In addition, the necessary processes for market surveillance, UDI and EUDAMED must be established in the QM system.
Key points of the new MDR include:
- Intensified market access process (scrutiny) for new Class III and Class IIb implantable products that supply medicines
- Higher classification of certain material and surgically invasive medical devices
- Additional testing of high-risk products such as implants
- Increased responsibility of manufacturers for liability and recording of complaints
- Better protection for clinical trial participants
- Better traceability of products already available on the market with the help of a new database and the assignment of individual UDI numbers
As the transition period is tight, all companies concerned should seek re-certification of their products as early as possible and cooperate with experienced specialists. However, since the certification process alone can take more than a year, manufacturers are given the opportunity to extend their old certification once if necessary in order to obtain sufficient time.
Important innovation: Unique Device Identification (UDI)
The new UDI makes it possible to identify and trace each individual medical device in order to quickly locate users if necessary and to remove products from the market if necessary. This even includes individual software versions and batches. The number should be affixed to each individual medical device and to the packaging. UDI numbers will be allocated by allocation bodies to be designated by the EU. Until the organisation is operational, it will be awarded by GS1, HIBCC and ICCBBA. For the end user, the innovation has the advantage that he can call up the UDI of his purchased and used medical devices in a publicly accessible free database.
Among other things, the following data is recorded:
- Type of product
- Sell-by date
- Certain contents
- Attributes such as "reusable".
The US-American FDA, which has been issuing UDI numbers for some time, serves as a model here. For software that is downloaded from the Internet without a physical data carrier, the UDI can then be displayed in the "Help" menu under "About...", for example. Every user who downloads this software can be identified by the manufacturer and contacted if necessary.
The new rule 11 of MDR for software
Medical software has steadily gained in importance in recent years. Until now, rule 10a, which has become rule 11 in the new MDR, applied to them. Rule 11 now clearly defines software used to predict or predict diseases as an active medical device. A higher classification of software, especially apps, will probably lead to a sharp decline in new medical apps. Experts even fear a weakening of medical innovation in Europe.
Software is specifically assigned to the individual classes on the basis of the following provisions:
1.) Class III: The software can have effects that cause an irreversible deterioration of the state of health or the death of a person.
2.) Class IIb: It can cause a serious deterioration of a person's health or a surgical intervention
3.) Class IIa: All software that provides information that is used to make decisions for diagnostic or therapeutic purposes.
4.) Class I: All other software
These definitions mean that almost all software falls into Class IIa or higher in accordance with the new Rule 11. Exceptions apply only to a few products, e.g. fitness apps.
What does this mean for the manufacturers?
If the medical software according to rule 11 no longer falls into class I, but into class II or higher, the effort for the manufacturers will increase considerably. They must set up and have certified a quality management system and involve certain authorities and bodies. This particularly affects innovative young start-ups and other developers, who now have to question the profitability of the new development of medical apps very critically due to the effort involved.
How can we help?
Konplan has the necessary expertise to guide medical apps and software safely through the new MDR regulations, to obtain the necessary CE certificates after passing the approval procedure and to apply for the UDI numbers in future.
We will be happy to advise you on complete documentation and try to make it as simple and uncomplicated as possible so that you can concentrate on your strengths. Do you have any questions about the new Medical Devices Ordinance MDR or the new Rule 11 for medical software? We are happy to support you.