Update – Obligations relating to implants and requirements placed on the reprocessing of medical devices

The majority of the new Omnibus Ordinance on the Sale of Medical Devices and the Amendment of Various Medical Device Regulations already came into force on 29 July 2014, (Federal Gazette 2014 I No. 35 p. 1227) and replaces legislation including the Ordinance on the Distribution Channels for Medical Devices (Verordnung über die Vertriebswege für Medizinprodukte – MPVertrV) and the Ordinance on Prescription Requirements for Medical Devices (Verordnung über die Verschreibungspflicht von Medizinprodukten – MPVerschrV). The changes to the MPBetreibV which are relevant for healthcare facilities such as hospitals and outpatient centres, which provide for special information and documentation obligations relating to implantable medical devices and new requirements relating to the reprocessing of medical devices, will first come into force, however, on 1 October 2015 following a transitional period for the implementation of the requirements.

I. Retrospective review of key changes to medical devices law in 2014

• The reclassification of medical devices requiring a prescription (in Section 1 of the Ordinance on the Sale of Medical Devices (Medizinprodukte-Abgabeverordnung – MPAV) only now states a prescription requirement for devices which in accordance with their purpose as determined by the manufacturer (including in the instruction manual and advertising materials) are intended for use by laypersons. The manufacturer is obliged when determining the user group to take factors into account such as the technical knowledge, experience and physical requirements of device users and this is likely to result in special challenges.
• The new regulation relating to devices which may only be sold in pharmacies (Section 2 (§ 2 MPAV) states that this obligation only now applies to certain medical devices intended for use by laypersons.
• “Sale restrictions” have also been standardised: the correct storage of medical devices is for example to be ensured by the point of sale (Section 3 (1) MPAV), although it remains unclear which specific requirements have to be met. The point of sale also, if necessary, has to ensure that expert advice is provided (Section 3 (2) and (3) MPAV), which likewise requires interpretation due to a lack of any more detailed explanations.
• The reprocessing of medical devices pursuant to the Medical Devices Operator Ordinance (Medizinprodukte-Betreiberverordnung – MPBetreibV) has for the purpose of clarification been separated in terms of its definition from maintenance. So that third parties are also able to carry out the maintenance of devices, the manufacturer has to provide appropriate information, the content and scope of which are not, however, described in any more detail.

II. Changes to the Medical Devices Operator Ordinance effective 1 October 2015

Obligations relating to implantable medical devices

To improve the safety of implants, the obligations in connection with implantable devices have been bundled and expanded in Section 10 MPBetreibV. The new Annex 3 to the MPBetreibV replaces the former annex in the Medical Devices Safety Planning Ordinance (Medizinprodukte-Sicherheitsplanverordnung – MPSV). The regulations now therefore not only apply for active implants (e.g. heart pacemakers), but also for a large number of additional non-active implantable medical devices: heart valves, non-absorbable vascular prostheses and stents, replacement hip or knee joints, vertebral body replacement systems, intervertebral disc prostheses and breast implants. Compliance with the new requirements is also subject to new provisions concerning administrative fines. (Section 13 Nos. 10 and 10a MPBetreibV), which likewise first come into force on 1 October 2015.

The new information and documentation obligations consist of the following three elements:

• The written patient information already provided for in Section 10 MPBetreibV is being streamlined and besides the necessary safety-relevant instructions on how to act after the device has been implanted now only contains the data for the necessary follow-up examinations (Section 10 (1) No. 1 MPBetreibV).
• An important new regulation is the introduction of an implant passport (Section 10 (1) No. 2 MPBetreibV), which has to be handed out to the patient concerned after surgery by the healthcare facility responsible for implanting the device.
  Besides the first and last name of the patient, this should also contain the device data (description, kind and type, as well as batch code or serial number of the implant, and the name or company name of the manufacturer of the device concerned), as well as information relating to the person who inserted the implant (implantation date and the name of the responsible person and the facility which carried out the implantation), and should in particular facilitate self-control by the patient in response to public warnings.
  In view of events in recent years in connection with defective implants, the legislator’s intention with the implant passport is to further improve patient safety with respect to the use of implants.
• Also new is the obligation according to which healthcare facilities in the event that corrective measures are necessary due to device issues have to ensure that the patients concerned can be contacted as quickly as possible. To this end they have to take appropriate measures for the documentation of implanted medical devices and store this documentation such that the group of patients concerned can also as a rule be identified within three business days via the type and batch or serial number of the implant, as well as via the name of the manufacturer (Section 10 (2) MPBetreibV). The exact scope of the documentation obligations is set forth in Section 16 (2) MPSV, according to which this must include the name, date of birth and address of the patient, the implantation date, the type and batch or serial number of the implant, as well as the responsible person pursuant to Section 5 of the German Medical Devices Act (Medizinproduktegesetzes – MPG).

Although the above regulations are initially aimed at healthcare facilities, which will soon see themselves exposed to an increased administrative burden, the regulations are also relevant for manufacturers in that they will increasingly have to provide healthcare facilities with more detailed product information due to the implementation of the new regulations.

Reprocessing of medical devices

In addition, the requirements placed on hygiene relating to the reprocessing of particularly critical medical devices (Category “C Critical”, e.g. ERCP catheters) are also being increased effective 1 October 2015 for reasons linked to patient safety. The certification of the quality management systems of reprocessors by an agency recognised by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten – ZLG) is for example being made obligatory. This obligatory certification will (also in the opinion of the German government) lead to considerable additional organisational effort and financial expense. Reprocessing a medical device without certification can ultimately be punished as an administrative offence (Section 13 No. 3 MPBetreibV).