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Anne Matousek
Senior Consultant QM & RA, Regulatory Affairs Expert

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08.06.2021

A RESTFUL HAND AND RESTFUL TRANSLATION

The addition of the MDR to national legislation still reveals some imponderables. To prevent you from tottering, seleon has smoothened the way for you.

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MDR and national legislation

The German Medical Device Adaptation Act (MPEUAnpG - Medizinprodukteanpassungsgesetz) to repeal the national implementation of the Directives 90/385/EEC, 93/42/EEC and 98/79/EC was already one year old in May 2021. We have already informed you about the contents of the MPEUAnpG and the new Medical Devices Law Implementation Act (MPDG - Medizinproduktedurchführungsgesetz).

But how does the national legislation look today - in June 2021 - at the final launch of the MDR?

The envisaged amendments to the following laws came into force on 26 May 2021.

  • Law on Advertising in the Health Care System (HWG – Heilmittelwerbegesetz)
  • Act on Protection against Non-Ionising Radiation in Human Applications (NiSG - Gesetz zum Schutz vor nichtionisierender Strahlung bei der Anwendung am Menschen)
  • Implant Register Act (IRegG - Implantateregistergesetz)

On 21 April 2021, the final version of the Medical Devices EU Adaptation Regulation (MPEUAnpV - Medizinprodukte-EU-Anpassungsverordnung) amended a number of laws relevant to medical devices. They also became valid on 26 May 2021.

 

New laws based on the MPEUAnpV that come into force on 26 May 2021

Medical Devices User Notification and Information Ordinance (MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung)

The new law and its articles implement reporting requirements for all those who professionally or commercially operate or use medical devices (physicians, dentists, forensic pathologists). Health professionals, users and patients are to be encouraged to report suspected serious incidents. This is defined by the MPAMIV as an incident where a serious incident cannot be ruled out according to MDR 2017/745. Patients or their relatives should inform their doctor/dentist/distributor and can also make a report to the competent authority, the BfArM. However, there is no obligation to notify patients. However, for persons who use medical devices professionally or commercially, the notification must be made immediately to the BfArM as the competent higher federal authority.

In addition, the MPAMIV describes the obligations of the BfArM and other authorities. This concerns, for example, requirements for the BfArM to publish information on safety corrective measures carried out. Among other things, no personal data may be included.

The MPAMIV will be amended again on 26 May 2022 within the framework of Article 2 of the MPEUAnpV; only the references to Regulation (EU) 2017/746 will then be added to the text.

Medical Device Law Implementation Act Fee Ordinance (MPDGGebV - Medizinprodukterecht-Durchführungsgesetz-Gebührenverordnung)

Since 26 May 2021, this new ordinance regulates the fees that the competent federal authorities may charge for activities. Thematically, decisions on medical devices, activities in the case of special approvals or within the framework of clinical trials, consultation procedures with consultation of the medicinal products authority or fees within the framework of market surveillance are regulated. Corresponding amounts are also charged for consultation, expert opinions and certificates. The range goes from 30 euros for certificates up to 50,000 euros for an expert opinion on a new medicinal product or a known medicinal product with a new intended use.



Changes from the MPEUAnpV applicable since 26 May 2021

Medical Devices Operator Ordinance (MPBetreibV - Medizinprodukte-Betreiberverordnung)

In the context of the changes to the MPBetreibV under the MDR, these are mainly updates of references and terms.

A central change that was outsourced to the individual member states under Article 17 (9) of the MDR deals with the topic of reprocessing. Now, at national level in Germany, the reprocessing of single-use devices by healthcare facilities is permitted and the MPBetreibV regulates which requirements of Regulation (EU) 2017/745 apply to these activities and which do not. Although no conformity assessment procedure is necessary, an assessment by a Notified Body is required. Furthermore, no EU declaration of conformity, CE marking or clinical evaluations need to be carried out.

In addition, health care facilities will be obliged to hand out the implantation card and the data contained therein.

From 26 May 2022, the law will be amended again to include Regulation (EU) 2017/46, which will then replace the IVDD.

Medical Devices Dispensing Ordinance (MPAV Medizinprodukte-Abgabeverordnung)

In the MPAV, there are only changes in the references to the underlying legislation.

 

Laws that ceased to have effect on 26 May 2021 as a result of the MPEUAnpV:

The following laws were repealed together with the previous Directives 90/385/EEC and 93/42/EEC on 26 May 2021:

  • Medical Devices Ordinance (MPV - Medizinprodukte-Verordnung)
  • Medical Devices Safety Plan Ordinance (MPSV - Medizinprodukte-Sicherheitsplanverordnung)
  • Medical Devices Fee Ordinance (Medizinprodukte-Gebührenverordnung)
  • Ordinance on Clinical Trials of Medical Devices (MPKPV - Verordnung über klinische Prüfungen von Medizinprodukten)

You are not familiar with the national legislation? You have so far mainly kept up to date with the MPG and are not yet familiar with the new procedure? Contact us with confidence. We will be happy to support you in interpreting the national and European legislation for placing medical devices on the market.

 

 

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.

Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. seleon advises you on your individual questions without any obligation.

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