MDR – What changes for medical device manufacturers

Author: Michaela Kauer-Franz

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Jan 2021

Table of Content

On May 26th 2021, the Medical Device Regulation (MDR) will become fully effective. With the entry into force, manufacturers are confronted with numerous challenges, which must be solved in advance, so that the future marketing of products is not delayed. The article lists what medical device manufacturers must pay particular attention to and outlines what has changed in the various areas of requirements and what has been newly added.

The Medical Device Regulation

The MDR, a catalogue of requirements, came into force in 2017 through an EU regulation, thus initiating the transition period which is still continuing today. With the new regulation, the old MDD lost its validity, which meant that the standards regarding the usability of medical devices were also revised and harmonized. IEC 62366-1 is the standard for the usability of medical devices, whereas IEC TR 62366-2 is a set of instructions for use of the former standard, which describes how it is to be applied. [1]

Changes and new requirements

There is no doubt that the requirements in the MDR are much more detailed than in the previous regulations. In addition, new requirements have been added which must be observed in the future. The complete catalogue of requirements is available online as an EU dossier, in which the guidelines contained in the annexes are particularly relevant for medical device manufacturers.[2] In the following subchapters, these are arranged by perspective to give you a quick overview.

According the products

There are new requirements for the products themselves. These include extensive specifications for post-market surveillance (PMS), which now has to follow an elaborated plan and return reports on usability or error messages. This periodic safety update report is used to ensure that errors are corrected and usability is improved even after publication. Clinical evaluations as well as trials have also been revised, especially regarding the type and quality of clinical data collected during the trials. In the context of post-market clinical follow-up (PMCF), this includes data collected in the context of PMS. This should ensure that the data are kept up to date.[3]

In the future, each product will also have a unique product identification number, called UDI, which will make product locations more easily identifiable and guarantee traceability. The revised passage on labelling, which is now also to be regarded as a new standard, also goes in this direction. For certain product groups, the EU reserves the right to introduce so-called Common Specifications, where existing harmonised standards are insufficient. Finally, the handling of the use of hazardous substances is still regulated, especially when it comes to carcinogenic and mutagenic materials and ingredients.[4]

According the technical documentation

Furthermore, the new requirements also apply to technical documentation, to which elements have been added that were not even mentioned in the MDD. Logically, the new documentation contains all the new MDR elements mentioned in the previous section. In addition, it is now necessary to include photos to describe the device, or the description of the intended users. Patient populations, indications and accessories for intended use must also be mentioned. An important innovation is also the explanation of physical principles, or the description of materials with body contact.

In addition, a plan for risk management must be submitted and suitability for use must now also be applied in the risk analysis. Also new are the testing of the software on different hardware, as well as the disclosure of the software architecture; tests with the software must not only take place in-house, but also in the real usage environment. Finally the storage time of the documentation of 5 to 10 years doubled.[5]

According the classification and approval

The classification also requires a reorientation: software has been upgraded and is no longer class I but IIa or higher. [6] Some products from IIb have been upgraded to III, especially in the area of implants. Conformity assessment has also been changed, but it can still be carried out by the manufacturer and does not require a medical devices authority. However, the scutiny procedure, which obliges bodies to forward new applications to the expert commission of the Medical Device Coordination Group for conformity assessment, will now apply to high-risk products. All this results in the Europe-wide uniform MDR certificate.[7]

According the traceability

Under the new rules, the traceability of products must be ensured even after they have been placed on the market. For this purpose, a Europe-wide database has been set up specifically for this purpose and further developed with MDR, whose aim is to ensure this: EUDAMED. Formerly reserved for state institutions, it is to be made available to manufacturers and the public. In addition, manufacturers must designate a qualified person who has specialist knowledge of medical devices. The terms “Private Label Manufacturer” (PLM) and “Original Equipment Manufacturer” (OEM) are not used in MDR and certain constellations in production outsourcing are no longer accepted. As a result, some patterns of marketing and placing products on the market must change (PLM-OEM construct).[8]

According the usability (special part)

Our article “The new MDR and its effects on usability“ [9] describes exactly which requirements have to be considered by manufacturers according to the IEC 62366-1 standard when creating a usability concept. The standards have been harmonized as far as possible. All usability aspects have now been combined in the IEC 62366-1 standard. In particular, the paragraphs on usability for medical devices have been revised as far as possible and supplemented by some new requirements, for example in the areas of user interfaces, use scenarios and use errors.[10]

INSERT: What the transition period means for manufacturers

The transition from MDD to MDR should have been completed this year on 26 May 2020, but due to the corona pandemic the European Council extended the transition period to 26 May 2021 by exactly one year. However, what gives manufacturers a sigh of relief at first, creates a lack of transparency with regard to the grace periods for special circumstances, such as the approval of legacy products or post-certification, which extend into 2028. We have provided precise guidelines on which issues are subject to which grace period in our article “Extension of MDR transition periods“ summarized for you. Particular attention should be paid to the section on the validity period of certificates. The sale of products that have been certified and published under the old system is not affected by this; it may be continued with restrictions.[12] Finally, when software is published by app stores, it is sometimes unclear which date is to be considered the date of placing on the market or the date of putting into service. According to the MDR, Article 3, Section 29 defines putting into service as follows: “Putting into service” means the moment when a product, with the exception of test products, is made available to the end user as a product which can be used for the first time on the Union market as a product ready for use according to its intended purpose.“[13]

Conclusion

One thing is clear: MDR brings with it many innovations that prevent or regulate existing practices of manufacturers. However, MDR also demonstrably endeavours to make devices safer, such as the labelling of substances with physical contact or the collection of data beyond the date of placing on the market. Manufacturers whose product certification is not yet based on the MDR should use the time until 26.05.2021 to meet all requirements of the new regulations in order to avoid unnecessary extra work or complications in product development or in the approval process. If this has not already been done, please contact us – we will be happy to advise you!

Further links:

EU dossier: REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning medical devices amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Directives 90/385/EEC and 93/42/EEC
http://data.consilium.europa.eu/doc/document/ST-10728-2016-INIT/DE/pdf
Structured EU Medical Device Regulation, MTD Verlag
https://www.mtd.de/gesundheitssystem/gesetze-verordnungen/eu-medizinprodukteverordnung-mdr