The new Medical Device Regulation 2017/745 is coming slowly, but surely: 26 May 2020 is the official date of application. Then the MDR will replace the Medical Device Directive 93/42/EEC. In the following article you will find out what has to be done until then and which important steps your company should take now.
MDD, MDR, 2017, 2020 - don’t get confused!
In May 2017, the new MDR - Medical Device Regulation became effective and with 26 May 2020 its validity becomes binding throughout Europe. Until now, the MDD directive 93/42/EEC on medical devices was in force and the MDR is now supposed to be a better version of its predecessor. A considerable difference to the present MDD is that as a regulation, the MDR has general validity and immediate effectiveness in all EU member states. Thus, the MDR provides an optimised and standardised regulation for the placing on the market of medical devices, with a stronger emphasis on product quality and safety. The following paragraphs explain how all these aspects will be implemented in detail.
What does the new MDR has to offer?
Significant changes affect the following areas:
- classification of medical devices
- conformity assessment procedures
- technical documentation
- clinical evaluation / investigation
- person responsible
- market surveillance
- reporting obligations
- quality management
But how do these changes look like in detail?
The classification of medical devices has been extended by some terms and rules, causing some existing products to be part of another/new class. In addition to the present classes Im (medical device with measuring function) and class Is (medical device with sterile function), there is a new class Ir (reusable surgical instruments). Further, under the MDR stand-alone software is now classified as class IIa or higher, whereas under the MDD it was mostly classified as class I. Moreover, there is an own rule for products that contain or consist of nanomaterials and products for the administration of drugs (so-called borderline products) become the centre of attention.
Depending on the class, with these changes the conformity assessment procedures vary now, too. In the case of class I devices, manufacturers can perform the conformity assessment procedures themselves and only under certain circumstances (class Im, Is, Ir), they must consult a notified body. Whereas with the other classes (class IIa, IIb and III) an involvement of the notified body is required. Further, the requirements for the placing on the market and the general procedures (different appendix numbers) have been changed. Entirely new is that manufacturers of class I medical devices - according to the industry association BVMed these are about 70% of the medical devices offered on the market - now must have an own quality management system. It does not have to be certified, but it has to function starting from 26 May 2020.
Another fundamental aspect that will change is the technical documentation. According to the MDR it has to be more precise and that is why its requirements have been specified (see MDR appendix II and III). Thus, the extent of the technical documentation has become significantly larger and all related documents need to be updated regularly.
For the clinical evaluation and trials, the MDR specifies how detailed and of what type and quality the clinical data must be. Here, the demands have risen significantly. That is why now, as a rule with high-risk devices clinical data must be collected always together with the medical device that needs to be evaluated. If data of competing products is to be used, their similarity must be proven and access to the clinical and technical data of the competing product is required. For now, it remains unknown how this will work in day-to-day practice - the MDR expects contracts on this between manufacturers. The evaluation of the available clinical data can, among others, be based on MEDDEV 2.7./1, rev. 4.
A major change is the introduction of the person responsible for regulatory compliance (article 15). This role corresponds to the concept of the safety officer for medical devices according to §30 of the German Medical Device Act, but up-to-date this role was only given in Germany. In comparison, the liability of the person responsible is significantly extended. Nevertheless, an important point which must absolutely be realised by every company.
Another focus of the MDR is the part on post-market surveillance (PMS) (chapter VII, section 1) as well as the part on general reporting obligations (vigilance) (chapter VII, section 2). The respective chapters of the MDR depict specific requirements that go beyond those of the EN ISO 13485. A post-market surveillance plan is of particular importance, an additional post-market surveillance report is required for class I devices. Further, a periodic safety update report (PSUR) is required for class IIa, IIb and III devices.
Requirements of the EN ISO 13485:2016 have been implemented. They represent essential changes in quality management and, in parts, additional obligations.
The database EUDAMED contributes to further transparency, for it is open to competitors, notified bodies and the public. Appendix VI of the MDR explains in detail what information economic operators need to enter in this database. EUDAMED also includes the UDI database (unique device identification). Hence, every medical device is clearly labelled, and it is possible to trace back the supply chain (traceability).
In addition, some aesthetic products or products without an intended medical purpose are now covered by the MDR, too (appendix XVI), which is basically a considerable change. In general, the new MDR places also higher requirements on products containing hazardous substances or single-use devices.
What do manufacturers have to do by now?
How does the transition phase look like?
Indeed, there are some aspects that manufacturers absolutely have to handle by now. These include amongst others:
- Training and appointment of the “person responsible for regulatory compliance” (article 15)
- Setting up or completing the QM system (a certification according to EN ISO 13485:2016 would be ideal) The extent of the QM system depends on the risk class of the devices, the size of the company and other factors.
- Structure and contents of the technical documentation must be adapted according to the changes in the MDR
- Clinical evaluation of all medical devices must be updated and, if necessary, clinical investigations must be conducted
- Performing the necessary market surveillance activities
- Implementing the UDI system within the company and acquiring the required UDI number ranges
- Clarifying whether the current notified body will also be notified under MDR, by when this will take place and whether the company’s certified products will then still fall under the new scope of the notified body
- If a previous class I device is now classified higher: searching for an appropriate notified body and concluding a certification contract with it
The following points should still be on the agenda after the day of application of the MDR:
- Performing a conformity assessment procedure with a notified body (except for class I devices)
- Issuing the declaration of conformity
- Applying the CE mark
- Registering the company and the products in EUDAMED
In addition to the tasks mentioned above, it is important that you develop a plan for your company for the time of the transition to MDR, defining the product life cycle of your medical devices. MDD certificates are valid only until 26 May 2024 – if there is no significant change, such as considerable changes to the product or, for example, a relocation of the production site or company headquarters. Therefore, it is important to know which products will be re-certified under MDD once more and which will already be approved under MDR. At the same time, this means that there is no “protection of the population”! Even devices that have already been approved under the MDD must go through the entire conformity assessment process of the MDR and comply with the respective requirements of the MDR.
But don’t bury your head in the sand!
At first sight, all this may seem like an overwhelming task, however: don’t bury your head in the sand!
We, the seleon gmbh, will help you well-directed in the transition from MDD to MDR with solutions perfectly fit for your company. So, 26 May 2020 can come without hesitation.
Please note that all data and listings do not have the claim of completeness, are without guarantee and serve the pure information.