In the course of the Corona crisis, the start of the European Medical Device Regulation was postponed by one year to May 2021 (read more in our article), and word has already got around. The corresponding German legislation - summarised in the German Medical Device Adaptation Act (Medizinprodukteanpassungsgesetz, MPEUAnpG) - has now 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. What exactly will the MPEUAnpG change? We can tell you one thing directly - it will not 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 – Medizinprodukterecht-Durchführungsgesetz). It regulates similar issues as the MPG, but is not a German implementation of the European requirements as before, but rather to be read in addition to MDR 2017/745. Thus, important aspects of the MDR, such as the basic safety and performance requirements or the person responsible for the first placing on the market, are not listed again. National requirements that go beyond the European requirements of the MDR include, for example, aspects such as the medical device advisor or extended requirements for clinical trials. Competent authorities are also given extended responsibility, and the catalogue of offences punishable by imprisonment and the catalogue of fines has become more comprehensive. Last but not least, companies in which medical devices are reprocessed/sterilized must also register with the authorities.
Although the MPDG is predominantly to be read as a supplement to MDR, it still contains twice as many paragraphs as the MPG. From the former 44 articles in nine sections, the MPDG now comprises 99 articles, divided into ten chapters. These chapters include:
- Purpose, scope and definitions
- Notification requirements, 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 monitoring
- Medical device advisor
- Competent authorities, regulatory powers, other provisions
- Special provisions for the Bundeswehr and civil defence and disaster control
- Penalties and fines
- Transitional provisions
The medical device advisor according to MPDG
If one reads § 83 of the new law, one briefly imagines oneself in the former § 31 of the MPG regarding the medical device advisor. Paragraphs 1 to 3 are absolutely identical in wording to the previous requirements for the medical device advisor. Only the qualification possibilities of the advisor have been extended and now also allow proof based on an "IT commercial training".
However, paragraph 4 has been amended to specify to whom the medical device advisor must refer in the event of side effects, interaction, malfunction, technical defects, contra-indications or other risks, namely the manufacturer, his authorised representative, if any, the importer or the person responsible for ensuring compliance with the regulatory provisions.
Thus, there are no major changes, at least in the area of medical device advisors, but they should of course be trained promptly to the new legislation.
DMIDS at BfArM - but no more DIMDI
As already announced in summer 2019, the BfArM and essential functional units of the German Institute for Medical Documentation and Information (DIMDI) were merged on 26 May 2020. Most medical device manufacturers are particularly familiar with the DIMDI notification of their products, but in future this will probably be more familiar as "DMIDS notification": According to § 86 of the MPDG, there will be a "German Medical Device Information and Database System" (Deutsches Medizinprodukteinformations- und Datenbanksystem) - DMIDS for short - via which, among other things, the relevant data for the EUDAMED database will be transmitted and further communication between the economic actors and the competent German authorities will take place. The aim is to make this new database system available by 31 December 2022. Currently, notifications are still made as usual via the DIMDI portal.
The position of the ethics committee in the context of an application for a clinical trial
In the future, when submitting applications for clinical trials, it must be taken into account 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 to the ethics committee must first be made and completed, and only then can the application to the BfArm be made with the complete documents according to Annex XV Chapter II of the MDR. Subsequent submission of the opinion of the ethics committee is therefore no longer possible, as was previously permitted.
The requirements for the ethics committees themselves have also been increased. § 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 application for approval by a sponsor to an ethics committee must be submitted via DMIDS in the future.
Further effects of the MPEUAnpG on existing legislation:
In addition to the replacement of the MPG by the MPDG, the German Medical Device Adaptation Act also leads to changes in other laws. Thus, in addition to the obvious laws such as the German Law on Advertising in the Health Care System (Heilmittelwerbegesetz) and the Product Safety Act (Produktsicherheitsgesetz), the Medicinal Products Act (Arzneimittelgesetz), the Social Security Code (Book 5) (Sozialgesetzbuch (5. Buch)), the Food and Feed Code (Lebensmittel- und Futtermittelgesetzbuch), the Electrical and Electronic Equipment Act (Elektro- und Elektronikgerätegesetz), the Chemicals Act (Chemikaliengesetz) and the Act updating the structural reform of the federal fee law (Gesetz zur Aktualisierung der Strukturreform des Gebührenrechts des Bundes) are also affected. Some amendments, such as those to the Medical Product Safety Plan Ordinance (Medizinproduktsicherheitsplanverordnung), mainly cover the dissolution of DIMDI and the new responsibility by the BfArM.
According to the current status, the Medical Devices Operator Ordinance (Medizinproduktebetreiberverordnung) remains in force within the framework of the MPDG.
Entry into force of the MPDG and the MPEUAnpG
According to the law published in the Official Journal, the MPDG or some parts and other amendments of the MPEUAnpG would already have come into force. However, within the framework of the "Second Act for the Protection of the Population in the Event of an Epidemic Situation of National Significance" of 19 May 2020, there was a postponement, which is described in detail below:
Already in force retroactively since 24 April 2020:
- § 7 of the MPDG "Special admission, authorization to issue ordinances
- § Section 90(3) of the MPDG 'Special provisions for the Bundeswehr and civil defence and disaster control - application and enforcement of the law, responsibilities - granting of a special licence'.
In force since 23 May 2020:
- § Section 87 of the MPDG "Fees and Expenses; Authorisations to issue Ordinances
- Amendments to § 71, § 127 and § 139 of the fifth Social Security Code
In force since 26 May 2020:
- Article 4b of the MPEUAnpG "Amendment of the BGA Successor Act
- Article 11a of the MPEUAnpG "Amendment of the Medical Devices Safety Plan Regulation
- Article 11b of the MPEUAnpG "Amendment of the Regulation on clinical trials of medical devices
- Article 12a excluding point 6 "Amendment of the Implant Register Act
- Article 16a, points 1 to 8, with the exception of point 3 "Further amendments due to the dissolution of the German Institute of Medical Documentation and Information
Large parts of the changes that have come into force refer to the changed responsibility and therefore necessary adjustment of the responsibility of the BfArM instead of the DIMDI in existing legislation.
In force from 1 October 2020:
- Amendment of Section 127 of the fifth Social Security Code
In force from 26 May 2021:
- The Medical Device Law Implementation Act
Entry into force on 1 October 2021:
- Article 2 "Amendment of the Medical Device Law Implementation Act" - Repeal of § 87
In force from 26 May 2022:
- Article 3 of the MPEUAnpG "Further amendments to the Medical Device Law Implementation Act" - addition of the aspects according to IVDR EU 2017/746
With this extension to include IVD products, Articles 6, 8, 10, 10c, 12, 14 and 16 of the MPEUAnpG will also come into force on 26 May 2022 to cover these products.
You are not yet familiar with the requirements of the German MPDG? You would like to deploy your medical device advisor reliably in the future? Your safety officer should also take over the role of the responsible person in the future? We at seleon GmbH will be happy to provide you with an individual analysis of the effects of the changes, adapted to your situation, and work with you to find out which legal changes will be relevant for you and when.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.
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 reflect on a daily basis.