The European Medical Device Directive (2017/745, EU MDR) came into force on 25 May 2017. In a three-year transition period until 25 May 2020, it replaces both the Medical Devices Directive 93/42/EEC (MDD) and the Directive 90/385/EEC on actively implantable medical devices (AIMDD).The new regulation is undoubtedly complex. Therefore, switching from the old directives to the EU MDR is not a “binary” process. Manufacturers need to look in detail at the dates, deadlines, and exceptions of the transition period. This article gives an overview of the respective roadmap.
- Mission “Smooth Transition”
- Can I Continue to Market my MDD/AIMDD-Compliant Medical Devices?
- What Happens if my MDD/AIMDD Compliant Medical Device Has a Higher Risk Class According to EU MDR?
- Are my MDD/AIMDD certificates still valid?
- Can I Place my MDR Compliant Medical Device Already on the Market or Put it Into Service?
- What Happens if EUDAMED is not Fully Functional Before the Date of Application?
- Are There Still Obligations From the old EU Directives After the End of the Transition Period?
Mission “Smooth Transition”The EU MDR contains numerous new and more stringent requirements. Nevertheless, after the transition period has expired, all parties involved must meet the new regulatory requirements if they want to market medical devices in the EU, i.e. make them available or put them into operation. The parties involved are manufacturers, importers and distributors. Particularly small and medium-sized enterprises therefore face considerable challenges. They will have to spend a lot of time and money to implement the new requirements.Therefore, the European legislator has presented a roadmap for a “smooth” transition period to the EU MDR. This includes, for example, exemptions for certain parts of the Directives, which will continue to apply. By this, the legislator wants to ensure that medical devices can be handled in accordance with the old directives. This is important, for example, for archiving documents or for vigilance. In addition, there should be a fallback solution if the European database EUDAMED does not function in time.In the opinion of many experts, however, the transition period is too short and the relevant provisions are partly unclear or incomplete. Some see this as a threat to the industry as a whole.The following figure gives an overview of the EU MDR road to application and the transition period.
Can I Continue to Market my MDD/AIMDD-Compliant Medical Devices?
Consider also the national implementations of the EU MDD/AIMDD by the respective member states (e. g. the medical device law in Germany).Nevertheless, you must ensure the following issues:
- valid MDD/AIMDD certificate(s) (Art. 120 (2)),
- continuous compliance of the product with the directives (Art. 120 (3)),
- no significant changes in design and intended purpose (Art. 120 (3))
“Significant changes” do not refer to restrictions on intended purpose or changes to the design as a result of a corrective measure as long as the competent authority assesses and accepts these as such.You must also take into account the requirements of the EU MDR, which apply instead of the corresponding requirements of the old EU directives:
- registration of economic operators and products (Art. 31 and 29),
- post-market monitoring (PMS) (Art. 83-86 and 92, Annex III, but without a PMS system as integral part of the QMS),
- market surveillance (Art. 93-100 with evaluation criteria of the old EU directives), and
- vigilance (Art. 87- 92).
As a manufacturer, you should sign an agreement with your Notified Body that it remains responsible for adequate monitoring of all applicable requirements for the products it certifies.Though, if EUDAMED is not yet fully operational, exceptions are possible (Art. 123 (3d/3e).The transitional period ends on 27 May 2025. Thereafter, stakeholders may no longer offer MDD/AIMDD-compliant products or put them into service (Art. 120 para. 4, “Sales rule”). These products may then no longer be traded. However, there is a difference between the time of “placing on the market” and the time of “making available on the market”. In addition, you should note that products from the second-hand sale are subject to Art. 120 (4).
What Happens if my MDD/AIMDD Compliant Medical Device Has a Higher Risk Class According to EU MDR?MDD/AIMDD-compliant products can be placed on the market or put into service according to Art. 120 (3) even if they are assigned to a higher risk class according to the MDR. The classification according to the old guidelines is therefore decisive here. This also applies to the MDR requirements (e.g. the Periodic Safety Update Report (PSUR)), some of which are already risk class dependent.
Are my MDD/AIMDD certificates still valid?MDD/AIMDD certificates issued by Notified Bodies before 25 May 2017 remain valid until the date indicated in the certificate (Art. 120 (2)). Exceptions are EC verification certificates (Annex IV/4) which expire on 27 May 2022. MDD/AIMDD certificates issued by Notified Bodies after 25 May 2017 expire on 27 May 2024 at the latest.After 27 May 2024, in any case, there will be no more valid AIMDD/MDD certificates.The MDD/AIMDD certificates do not include declarations of conformity.In principle, a manufacturer can have both valid AIMDD/MDD and MDR certificates in parallel until the end of the transition period for certificates on 27 May 2024.
Can I Place my MDR Compliant Medical Device Already on the Market or Put it Into Service?The EU MDR has come into force on 25 May 2017, and hence, manufacturers can already place MDR-compliant devices on the market (Art. 120 (5)).This also applies to custom-made products (Art. 2 (3)) and systems and procedure packs (Art. 2 (10-11)).If you want to market your medical device in accordance with EU MDR, you must
- meet the product requirements of the MDR (Annex I) by conducting a conformity assessment procedure (Art. 52), and
- fulfil certain obligations of the EU MDR such as clinical evaluation, risk management, quality management, post-market surveillance, technical documentation and other reports as well as an appropriate insurance to cover the costs associated with defective devices.
What Happens if EUDAMED is not Fully Functional Before the Date of Application?Some EUDAMED dependent regulations, e. g. the registration of products and economic operators, fall back to the corresponding provisions of the former EU directives.Other EUDAMED dependent regulations cannot be fulfilled completely, e. g.:
- The manufacturer appoints the person responsible for regulatory compliance (Art. 15), but the registration in EUDAMED is done later then.
- The manufacturer cannot apply for the assignment of an unique device identifier (UDI) (Art. 27 (3)) without a functioning EUDAMED.
- The manufacturer cannot provide an implantation card without having a functioning unique identification system (UDI) system in place.
There is a transitional period of 18 months during which you can register your medical devices “step by step” in EUDAMED (Art. 29 Para. 4). The same applies to medical device certificates that have been approved by the Notified Bodies. The prerequisite is, of course, that EUDAMED works.
Are There Still Obligations From the old EU Directives After the End of the Transition Period?Yes, for manufacturers this means that they must remain vigilant and keep the documentation of a medical device available for an indefinite period (Art. 122 para. 1). You should therefore consider and plan the higher effort if you have both MDR compliant and MDD/AIMD compliant devices on the market.You can continue clinical trials (in the EU MDR called “clinical investigations”) that started before the date of application of the EU MDR according to the requirements of the EU Directives (Art. 120 Para. 11). However, the EU MDR requirements apply to the reporting of serious adverse events and product defects.You can find more transitional provisions in Art. 120 (9-10).
SummaryIn summary, manufacturers must check:
- how long the respective MDD/AIMDD certificates are still valid,
- the differences in requirements between new and old legislation for their products,
- whether the selected Notified Body is already designated under the MDR, and
- whether the EUDAMED database is already operational, as many requirements depend on it.