The European Commission has revised the existing Medical Device Directives to improve patient safety. The new Medical Device Regulation (EU) 2017/745 (MDR) entered on May 25, 2017. After postponing the start of its application in April 2020, the transition period now ended on May 26, 2021. The MDR replaces the previous EU Directives 93/42/EEC and 90/385/EEC and does not need to be transposed into national law but is directly applicable in the member states. This fact leads to a unification of standards for medical devices within the European Union.
In addition to new devices, all approved devices on the market must also undergo new certification following the MDR. Notified bodies must also undergo a re-designation process, which has not yet been completed (December 2021).
As Germany’s number one medical technology location, Baden-Württemberg, with its 842 companies, is heavily affected by the MDR. In the summer of 2019, Baden-Württemberg became the first state to provide funds for an emergency aid program through the Baden-Württemberg Ministry of Economics, Labor and Housing. MDR Soforthilfe BW, coordinated by BIOPRO Baden-Württemberg, offers pragmatic and user-oriented support services with five non-individual company measures. These help medical technology companies to implement the new requirements in a time- and resource-saving manner. The immediate assistance program, which previously focused on the MDR, has been expanded to include support services for manufacturers of in vitro diagnostics and has been available in an adapted format since January 2021 as MDR & IVDR Soforthilfe BW.
The most significant changes at a glance
The MDR brings new and higher requirements for companies and monitoring facilities in many areas. Important changes are:
For example, classification changes for many products, with the higher classification of software, material medical devices, reusable surgical invasive instruments, and products containing nanomaterials
In risk class, I, subclass Ir (“r” for “reusable”), was introduced for reusable surgical instruments.
A consultation procedure in connection with the clinical evaluation is provided for active devices of class IIb, which deliver or deliver drugs to the Body, and implants of class III. Experts are involved in the conformity assessment (scrutiny procedure)
1. The requirements for clinical evaluation have increased. At the same time, reference to the clinical data of a similar product (equivalence assessment) is becoming much more complex and, according to experts, challenging to implement. As a result, there is an increasing need to conduct clinical trials – here, too, the MDR increases the requirements.
The requirements for the quality management system and technical documentation, and post-market surveillance have increased1.
Introducing a new product identification number (Unique Device Identification, UDI) also results in new labeling obligations. The introduction of UDI labeling is being phased in by class to improve product traceability.
The requirements for market surveillance have increased. Manufacturers will be required to deposit data about their company, their products, and information on UDIs in the Eudamed database as an electronic vigilance and market surveillance system. This Regulation is still in the implementation phase, with all modules expected to be available from May 2022 (as of December 2021)1,
2. Each manufacturer must internally appoint at least one “Responsible Person” for regulatory compliance. Their duties go beyond those of the safety officer. Likewise, the requirements regarding the qualification and experience of the “responsible person” are increasing. For companies with less than 50 employees, there is an exception under certain conditions that this function can also be appointed externally.
3. Significant changes are also occurring in the cooperation between Original Equipment Manufacturers (OEM) and Private Label Manufacturers (PLM).
The National Working Group for the Implementation of the New EU Regulations on Medical Devices and In-vitro Diagnostics (NAKI) was established by the German Federal Ministry of Health. The results will be published on the website.
Deadlines
Extension of the transition period:
On April 3, 2020, the European Commission published a proposal to postpone the start of the MDR validity period. Following adoption by the European Parliament and Council in April 2020, the Adaptation Regulation (EU) 2020/561 amending Regulation (EU) 2017/745 on medical devices was published in the Official Journal of the European Union on April 24, 2020. 4, 5, 6
The effective date of the Medical Devices Regulation EU 2017/745 has been postponed by one year to May 26, 2021.
As a result, all of the following stated deadlines previously referred to May 26, 2020, have now been moved to May 26, 2021.
Deadlines of the MDR that went into effect on May 26, 2017:
“Certificates issued by Notified Bodies before May 25, 2017, following Directives 90/385/EEC and 93/42/EEC shall remain valid until the date specified in the certificate, except in the case of certificates issued under Annex 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC, which shall cease to be valid no later than May 27 2022.” 7
“Certificates issued by Notified Bodies after May 25, 2017, following Directives 90/385/EEC and 93/42/EEC shall remain valid until the end of the specified period, which shall not exceed five years from the date of issue. However, they shall cease to be valid no later than May 27, 2024.” 7
Article 120, paragraph 4: “Devices lawfully placed on the market before May 26, 2020, by Directives 90/385/EEC and 93/42/EEC and devices placed on the market as of May 26, 2020, based on a certificate referred to in paragraph 2 of this Article may continue to be made available on the market or put into service until May 27, 2025.” 7 Note here that Article 120, paragraph 4 has been adapted by subsequent corrigenda.
The detailed provisions can be found in the regulation texts and in the NACI working group “Transitional Provisions” results.
Deadline changes after the corrigenda of 25/11/2019 and 23/04/2020 – Important changes:
For some of the products that belonged to Class I according to the old directives, changes have occurred due to the corrigenda of 25/11/2019 and of 23/04/2020. These concerns devices that are classified higher and for which, according to the new Regulation, cooperation with a Notified Body is now required. In particular, reusable surgical instruments (class Ir), software, products with nanomaterials, and material products are affected. As a result of the corrigendum, these products may now also be placed on the market until May 2024, provided they have a valid declaration of conformity under the old directives before May 26, 2021. This applies until the certificate’s expiry, which may also be the case before May 2024. These deadlines only apply as long as the product is not significantly modified. In addition, all other requirements of the MDR must already be met, such as post-market surveillance 6, 8.
Article 120(3) has been amended as follows:
“By way of derogation from Article 5 of this Regulation, a device which is a Class I device as defined in Directive 93/42/EEC, for which an EU declaration of conformity has been drawn up before May 26, 2020 [new: May 26 2021], and for which the conformity assessment procedure under this Regulation requires the involvement of a notified body, or for which there is a certificate per Directive 90/365/EEC or Directive 93/42/EEC which is valid under paragraph 2 of this Article, may be placed on the market or placed on the market until May 26, 2024. May 2024, provided that it continues to comply with one of those Directives as of May 26, 2020 [new: May 26, 2021], and provided no significant changes in design and intended use.” 6, 9
Article 120(4) has been amended to read as follows:
“Devices lawfully placed on the market before May 26, 2020 [new: May 26, 2021] following Directives 90/385/EEC and 93/42/EEC and devices placed on the market as of May 26, 2020, under paragraph 3 of this Article may continue to be made available on the market or put into service until May 26, 2025.” 6, 9
Needle eye Notified Body
The products themselves and the certification bodies that certify the products under the new Regulation must reapply to become a Notified Body and be re-designated after the examination. There were 49 Notified Bodies in the EU that are allowed to certify under the EU MDD10. Fifty-four have applied for designation under the MDR10. Of these, 25 Notified Bodies have been newly designated for certification under the MDR, six of which are in Germany 11. The current status can be found in the NANDO database (as of December 2021).
It is feared that there will be a severe shortage of Notified Bodies. This includes their smaller number, higher requirements, extensions of responsibility for products that were not previously subject to supervision by a Notified Body, and the required recertification of all products according to MDR. With the postponement of the MDR effective date, it remains to be seen how the current bottleneck will play out in the future.
The short transition periods and the late, not yet complete re-designation of Notified Bodies are a significant challenge for all stakeholders. In June 2018, the Conference of Economics Ministers, therefore, called on the German government, on the initiative of Economics Minister Dr. Nicole Hoffmeister-Kraut and her then Bavarian colleague Franz Josef Pschierer, to ensure a smooth process for small and medium-sized enterprises when implementing the European requirements and to create support services for access to clinical trials. “By tightening the European regulations for medical devices, a considerable additional financial and personnel effort is created, especially for small and medium-sized enterprises in the healthcare industry. Such requirements must be introduced in a business-friendly manner. This is the only way to make the German medical technology industry fit for the future,” emphasized Minister 12.
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