At present, there is only one topic dominating the headlines: COVID 19 - the Corona Pandemic. But between all the ever-increasing number of cases, circulations and hoarding stories, there was another news item that was received with interest by many manufacturers: The postponement of the MDR to 2021. But what exactly is behind this news? A closer look at the proposal of the EU Commission is worthwhile!
On April 3, 2020, the EU Commission published a communication in its virtual press room stating that, due to the coronavirus pandemic, it is proposing to postpone the date of application of the European Medical Device Regulation 2017/745 by one year to May 26, 2021. This is necessary due to the current demand for vital medical devices but also because of the high burden on national authorities, health care institutions and economic operators. However, the proposal has not yet been adopted and the postponement has not yet been finally secured. Moreover, it is in no way a matter of postponing all deadlines by one year. The amending regulation to the medical device regulation has packed a punch.
What other hurdles still have to be taken?
The Commission proposal is currently passing the ordinary legislative procedure of the EU. The first reading in the European Council took place before Easter. The Council introduced further amendments to the proposal. There has not yet been a reading and approval by the Parliament, but this was expected on 16 April 2020. However, both the Council and the Commission recommend the adoption of the proposal and point out that this must be done before 26 May 2020, otherwise the directives would be revoked and thus the MDR would enter into force.
It's only a pleasure deferred!
Anyone who has so far assumed, based on the headlines, that MDR in its entirety will now be postponed by one year is mistaken. Strictly speaking, the period of entry into force with all its details will only be shortened by one year - and that at the beginning. As a result, all those who would have to undergo a conformity assessment according to MDR in the period from 26 May 2020 to 26 May 2021, but who are not ready for it yet, can take a deep breath. However, not all transition periods and expiry dates will be postponed by one year, but will remain with the known dates. Individual aspects, such as the introduction of the UDI, are only postponed by one year for the most part. In the worst case, this means that even more manufacturers will have to obtain certification in even less time. Therefore the proposal as revised by the Council provides that prepared manufacturers and notified bodies will be able to apply the MDR to the greatest possible extent as early as May of this year.
The following list shows which data are postponsed - and which are not:
- In general the MDR applies only from 26 May 2021 (Article 123(2))
- The MDD and AIMD will not be repealed until 26 May 2021, with the exception of vigilance requirements, the keeping of records and the exceptions mentioned in the article (Article 122)
- Manufacturers and notified bodies wishing to obtain certification or notification under the MDR now may do so earlier - and earlier in this case means before 26 May 2021 (Article 120 (5) and (6))
- Voidance of all notifications of notified bodies under the MDD or AIMD only by 26 May 2021 (Article 120 (1))
- postponing until 26 May 2021 the adoption of the common specifications and their application from the same date, if determined in accordance with Article 9, for products without an intended medical purpose listed in Annex XVI (Articles 1, 17)
- reprocessing only of single-use products placed on the market until 26 May 2021 and not May 2020 in accordance with Directive 93/42 EEC or after that date in accordance with MDR (Article 17)
- Publication of the notice on the functionality of the EUDAMED database and the EU Commission's compliance with the associated deadlines postponed to 25 March 2021 (Article 34)
- the obligations and requirements in relation to Eudamed are only valid from 26 May 2021 or 6 months after publication, depending on the functioning of EUDAMED (Article 123(d))
- Accordingly, the applicability of certain aspects of Articles 29 and 56 (Article 123(e)) may be deferred
- Postponement of the notification to the Commission of the penalties envisaged by the Member States until 25 February 2021 - thus giving the Member States more time to prepare (Article 113)
- Clinical investigations according to MDD or AIMD may be started up to 26 May 2021, and the notification of serious adverse events and device deficiencies according to MDR must also be made as of 26 May 2021 (Article 120 (11))
- Validity of Articles 35 to 50 until 26 May 2021 only for notified bodies which have also submitted an application for notification (Article 123 (3))
- The provision by the Commission of scientific guidelines for the uniform interpretation of the criteria for the assessment procedures for certain Class III and IIb products is postponed until 26 May 2021
The following points will not be changed should the EU adopt the amending Regulation:
- No extension of the period of validity of MDD and AIMD certificates - the expiry date remains May 2022/2024 at the latest (Article 120 (2))
- The provision and putting into service of products placed on the market according to MDD or AIMD may nevertheless only take place until 26 May 2025 at the latest (Article 120 (4))
- No postponement of the deadline for affixing the UDI carriers on the product labelling and on the higher packaging levels in accordance with Article 27 (4) of the MDR (Article 123 (f))
- No postponement, but a clearer formulation is given to the deadlines for applying the UDI to reusable products depending on their classification (Article 123 (g))
- A further, unchanged deadline under Article 123 is the application of the coordinated assessment procedure for clinical investigations from 2027 on
Other important changes made to the MDR by the Commission's COVID-19 amending Regulation
- Extension of the exemptions from the conformity assessment procedures - medical devices can be placed on the market under the exemption clauses of the MDR, MDD or AIMD for the period from the validity of that Regulation until 25 May 2021
A close reading thus once again reveals old familiar facts: it is not worth burying one's head in the sand and postponing work on the transition to MDR. The planned "postponement" of Medical Device Regulation serves primarily to ensure the supply of critical medical devices and is intended in particular to relieve the EU and the member states in the current situation. Manufacturers must nevertheless have shifted to an MDR certificate by May 2024 when their MDD/AIMD certificates expire. So, clear your head, put the Corona News aside and get to work. We will be happy to provide you with active support.
MDD versus MDR - Basic information on the European Medical Device Directive
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 Medical Device Regulation entail?
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 (or 2021 due to Corona).
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 investigations, 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 Medical Device Regulation:
- 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 (and also the 26th of May 2021, if there is a postponement due to Corona) can come without hesitation.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.