The effective date of the European Medical Devices Regulation was postponed by one year to May 2021 in the wake of the Corona crisis (read more in our article), and word has already spread. The associated national legislation – summarized in the Medical Device Adaptation Act (MPEUAnpG) – has since been passed, published in the Official Journal and is already applicable in parts since May 2020. However, the real start will not be until May 2021. So what exactly are the changes brought about by the MPEUAnpG? One thing we can tell you straight away – it won’t necessarily be shorter.
Probably the most important change introduced by the MPEUAnpG is the replacement of the previously familiar MPG by the new Medical Device Law Implementation Act (MPDG). It regulates comparable topics to the MPG, but is not a German implementation of the European requirements, as was previously the case, but rather should be read in addition to the MDR 2017/745. Thus, important aspects of the MDR, such as the essential safety and performance requirements or the person responsible for placing the device on the market for the first time, are not listed again. National requirements that go beyond the European ones of the MDR include, for example, aspects such as the medical device advisor or extended requirements for clinical investigations. Competent authorities are also given extended responsibilities, and the catalog of actions punishable by imprisonment and the list of fines have become more extensive. Last but not least, establishments in which medical devices are reprocessed/sterilized must also register with the authorities.
Although the MPDG is mainly to be read as a supplement to the MDR, it nevertheless comprises twice as many paragraphs as the MPG. The former 44 articles in nine sections have currently become 99 articles in the MPDG, divided into ten chapters. These chapters include:
Purpose, scope and definitions
Obligations to notify, placing on the market and putting into service of products and making them available on the market, other provisions
Notified bodies, testing laboratories, conformity assessment bodies for third countries
Clinical trials and other clinical investigations
Vigilance and surveillance
Medical device advisors
Competent authorities, ordinance authorizations, other provisions
Special regulations for the German Armed Forces, civil defense and disaster control
Penal and fine provisions
Transitional provisions
The medical device advisor according to MPDG
If one reads § 83 of the new law, one imagines oneself briefly in the former § 31 of the MPG to the medical device advisor. The wording of paragraphs 1 to 3 is absolutely identical to the previous requirements for the medical device advisor. Only the qualification options for the consultant have been expanded and now also allow proof based on an “IT commercial training”.
Paragraph 4, however, has been amended to specify who the medical device advisor must contact in the event of side effects, mutual influences, malfunctions, technical defects, contraindications or other risks, namely the manufacturer, his authorized representative, if any, the importer or their person responsible for compliance with the regulatory requirements.
Thus, there are no major changes, at least in the area of medical device advisors, but they should of course be trained promptly on the new legislation.
The DMIDS at the BfArM – no more DIMDI for it.
As announced in the summer of 2019, the BfArM and key functional units of the German Institute for Medical Documentation and Information (DIMDI) have been merged as of May 26, 2020. Most medical device manufacturers are particularly familiar with the DIMDI notification of their products, but this will probably be more familiar as “DMIDS notification” in the future: According to § 86 of the MPDG, there will be a “German Medical Device Information and Database System” – DMIDS for short – which will then be used, among other things, to transmit the relevant data for the EUDAMED database, as well as for further communication between the economic operators and the competent German authorities. The aim is to make this new database system available by December 31, 2022. Currently, the reports continue to be submitted as usual via the DIMDI portal.
The position of the ethics committee in the context of an application for a clinical trial
When submitting applications for clinical trials, it must be noted in the future that the ethics committee and the BfArM can no longer become active at the same time, but that the applications must be submitted one after the other. Thus, the application must first be submitted to the ethics committee and completed, and only then can the application be submitted to the BfArm with the complete documentation in accordance with Annex XV Chapter II of the MDR. Subsequent submission of the opinion of the ethics committee, as previously permitted, is therefore no longer possible.
The requirements for the ethics committees themselves have also been increased. § Section 32 of the MPDG, for example, lists the composition and necessary qualifications of the members and also specifies requirements for the statutes or rules of procedure of each ethics committee.
It should also be noted that any requests for approval by a sponsor to an ethics committee must in the future go through the DMIDS.
Other effects of the MPEUAnpG on existing legislation:
In addition to replacing the MPG with the MPDG, the Medical Device Adaptation Act also leads to changes in other laws. For example, in addition to the obvious laws such as the Medical Devices Advertising Act and the Product Safety Act, the Medicines Act, the Social Security Code (Book 5), the Foodstuffs and Feedstuffs Code, the Electrical and Electronic Equipment Act, the Chemicals Act and the Act to Update the Structural Reform of Federal Fee Law are also affected. Some changes, such as those to the Medical Device Safety Plan Ordinance, predominantly cover the dissolution of DIMDI and the new responsibility by BfArM.
As things stand, the Medical Device Operator Ordinance (MPBetreibV) will remain in place as part of the MPDG.
Entry into force of the MPDG and the MPEUAnpG respectively
According to the law published in the Official Gazette, the MPDG or some parts and other amendments of the MPEUAnpG would have already entered into force. However, under the “Second Law for the Protection of the Population in the Event of an Epidemic Situation of National Significance” of May 19, 2020, there was a postponement, the details of which are as follows:
Retroactively since April 24, 2020 already in force:
§ Section 7 of the MPDG “Special authorization, authorization to issue ordinances”.
§ Section 90(3) of the MPDG “Special regulations for the armed forces and civil defense and disaster control – application and enforcement of the law, responsibilities – issuance of a special approval”
In force since May 23, 2020:
§ Section 87 of the MPDG “Fees and expenses; powers to issue ordinances”.
Amendments to § 71, §127 and §139 of the Fifth Social Code
In force since May 26, 2020:
Article 4b of the MPEUAnpG “Amendments to the BGA Succession Act”.
Article 11a of the MPEUAnpG “Amendment of the Medical Devices Safety Plan Ordinance”.
Article 11b of the MPEUAnpG “Amendment of the Ordinance on Clinical Trials of Medical Devices”.
Article 12a excluding number 6 “Amendment of the Implant Register Act”.
Article 16a numbers 1 to 8, with the exception of number 3 “Further amendments on the occasion of the dissolution of the German Institute for Medical Documentation and Information”.
Large parts of the amendments that came into force relate to the changed responsibility and therefore necessary adjustment of the responsibility of the BfArM instead of the DIMDI in existing legislation.
Effective October 1, 2020:
Amendment to Section 127 of the Fifth Social Code.
In force from May 26, 2021:
The Medical Device Law Implementation Act.
In force from October 1, 2021:
Article 2 “Amendment of the Medical Device Law Implementation Act” – Repeal of Section 87.
In force from May 26, 2022:
Article 3 of the MPEUAnpG “Further amendments to the Medical Device Law Enforcement Act” – addition of the aspects according to IVDR EU 2017/746.
With this addition of IVD products, Articles 6, 8, 10, 10c, 12, 14 and 16 of the MPEUAnpG will also come into force on May 26, 2022 to cover them as well.
You are not yet familiar with the requirements of the MPDG? You would like to reliably deploy your medical device advisors in the future? Your safety officer should also assume the role of the responsible person in the future? We, seleon GmbH, would be happy to prepare an individual analysis of the effects of the changes for you, tailored to your situation, and to work with you to find out which changes in the law will be relevant for you and when.
Please note that all information and listings do not claim to be complete, are without guarantee and serve purely as information.
Due to the rapidly changing situation in the context of the Covid 19 pandemic, changes in legal or regulatory requirements may occur at short notice, which we cannot map on a daily basis.
