The familiar EU Directives relating to the manufacture and sale of medical devices, Directive 90/385/EEC on active implantable medical devices (AIMD), Directive 93/42/EEC (PDF) concerning medical devices (MDD) and Directive 98/79/EC on in-vitro diagnostic medical devices (IVDD), currently remain in effect. They have been implemented into national law in Germany by the Medical Devices Act (only in German) and the Ordinances enacted under that statute.
Upon expiration of the various transitional periods, the current Directives will be replaced by the two EU Regulations which have already taken effect, Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR). Due to the outbreak of the coronavirus pandemic, the entry into effect of the MDR was postponed by one year, to 26 May 2021. Once the Regulation enters into effect, it will not require implementation into national law, so that the Medical Devices Act will no longer be in effect in its current form. Once the MDR takes effect, the Medical Devices Act will be replaced by the Implementing Act for Medical Devices Law [Medizinprodukterecht-Durchführungsgesetz] (PDF only in German).
The competent supervisory authorities are already conducting regulation in cognizance of the fact that the provisions of the MDR will take binding effect as of 26 May 2021. In particular, manufacturers of Class I medical devices will have no additional transitional period after 26 May 2021: Class I devices will be required to meet the requirements of the MDR as of that date!
Accordingly, the following steps need to be taken for the placement on the market of Class I medical devices in accordance with the MDR (based on the attached Medical Device Coordination Group (MDCG) guidance document) (PDF).
1. Confirm that the product is a medical device
This is the case e.g. with respect to medical face masks/OP masks.
2. Check whether the product was correctly classified as a Class I medical device
3. Make sure that the device meets the general safety and performance requirements specified in Annex I to the MDR
In particular, manufacturers are to perform a risk-benefit analysis as part of their risk management systems. Harmonized standards and common specifications may be used to document compliance with the applicable requirements.
4. Conduct a clinical evaluation
The MDCG expressly stresses the importance of the clinical evaluation for the MDR and notes that the MDR requires manufacturers, particularly manufacturers of Class I medical devices, to analyze and compare alternative devices, take into account post-market data, demonstrate the acceptability of the benefit-risk ratio based on clinical data and conduct clinical investigations if and when the available clinical or performance data is insufficient.
5. Prepare technical documentation
Manufacturers of Class I medical devices must also prepare technical documentation as specified in Annexes II and III to the MDR. The MDR introduces various changes relative to the Directives which are currently in effect. For example, a rationale must be cited for the classification and a basic UDI-DI must be assigned. A reference to previous generations of the device and similar devices must also be included, if applicable. Reference should also be made to the valid harmonized standards and “common specifications” which have been applied and the post-market surveillance system must be described as well.
6. Prepare instructions for use and labeling
In exceptional cases, instructions for use may be dispensed with for Class I devices if the devices can be used safely without instructions for use, in accordance with Annex I Chapter III No. 23.1(d) of the MDR. If instructions for use are required, national language requirements must be taken into account. The symbols used in labeling are to conform to the harmonized standards/common specifications. The product must be labeled as a “medical device.”
7. Establish a QM system
Manufacturers, including manufacturers of Class I medical devices, are required to establish and maintain a QM system. They are also required to appoint a person responsible for regulatory compliance in accordance with Article 15 of the MDR.
8. Draw up an EU Declaration of Conformity (including translations into the national languages of the countries in which the device will be made available).
9. Affix the CE marking
10. Register the device and manufacturer with DIMDI (in the future: the EUDAMED database)
11. Implement a post-market surveillance system
the MDR requires manufacturers to establish a post-market surveillance system as part of their QM system. Manufacturers of Class I medical devices are required to prepare a “post-market surveillance report.”
12. Implement a vigilance system
in accordance with the MDR, manufacturer of Class I medical devices are also required to report “field safety corrective actions” (FCSAs). Until the EUDAMED database is operational, such reports in Germany will be made to the Federal Institute for Drugs and Medical Devices (BfArM). Eventually, these reports will be added to the EUDAMED database. In addition to their existing reporting duties, manufacturers are required to take corrective actions if they become aware that their devices are non-conforming.
Summary and recommendation
The MDR’s requirements are far from trivial, particularly when it comes to Class I medical devices. In particular, there is no way around the clinical evaluation for these manufacturers, contrary to the widely disseminated views of many economic operators. Manufacturers would be well-advised to take advantage of their extra time, now that the MDR’s entry into effect has been postponed due to the coronavirus pandemic, to ensure that their companies and products comply with the MDR.back