Short and helpful facts - Document Retention times

Within the new MDR, document retention times were changed. Documents like the technical documentation shall now "be kept for a period of time of at least ten years after the device has been placed on the market. In the case of implantable devices the period shall be at least 15 years.

Class I resusable surgical instruments

Short and helpful facts from the new MDR: Manufacturers of class I reusable surgical instruments will have to involve a notified body with regards to the aspects related to the reuse of the devices. This is new as the current MDD did require involvement of notified bodies in class I devices only if they were sterile or had a measurement function.

New MDR will require further changes to IFU

Short and helpful facts from the new MDR: There are further requirements for the Instructions-for-Use of Medical devices under the new MDR. The IFU will have to include "A notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State where the user and/or patient is established.

Technical Documentation as per the new MDR

Within the new MDR, the Technical Documentation was structured as per GHTF STED and is now described in Annex II of the new MDR. You can download a free example for a table of content of a technical documentation for a non-active medical device. For purpose of international registrations, some additional requirements were added

Economic Operators

The proposed European Medical Device Regulation (MDR) introduces the concept of the Economic Operators. An organization shall identify their roles undertaken in Europe. These roles can include Manufacturer, Authorized representative, Importer or Distributor. These terms were already introduced within the ISO 13485:2016. Articles 9 to 12 of the proposed MDR defines the obligations of these Economic Operators. The attached document provides a rough and generic overview of these obligations.

Final Revisions of MDR and IVDR

Final version of the European Medical Device and IVD Regulations were published on 22 February 2017

Comparison of Annex I of the new MDR versus the Essential Requirements of the current MDD

Within the final draft (February 2017) for the new Medical Device Regulation, the current 13 Essential Requirements were replaced by 23 General Safety and Performance Requirements. Unfortunately, the proposed MDR doesn’t provide a trace matrix between the current and the new requirements. The file that can be downloaded from this page was compiled to provide such comparison. Although it was actually quite difficult to align the new requirements one-by-one with the current requirements, the table may be supportive when manufacturers are asked to establish a revised checklist for the conformity assessment under the new MDR.

Short and helpful facts - the meaning of device

The new MDR does not apply to Medical devices only but also to the groups of products without an intended medical purpose that are listed in Annex XVI of the MDR. Therefore the wording device means medical devices, accessories to medical devices and products without an intended medical purpose that are listed in Annex XVI

Short and helpful facts - General safety and performance requirements

Slight change in wording: General safety and performance requirements will replace the previous wording of Essential requirements. More important, Annex I will call for 23 requirements, instead of currently 13 requirements.

Short and helpful facts from the new MDR: Vigilance reporting time

Timelines for vigilance reporting will be shortened significantly. Under the current MEDDEV 2.12.-1 the maximum time for reporting incidents was 30 calendar days following awareness date. Article 87 of the new MDR requires a maximum reporting time of 15 days following the awareness of a serious incident.

Short and helpful facts from the new MDR: IFU to be put on the website

General Safety and Performance Requirements (former Essential Requirements) number 23.1 will probably mean that manufacturers will have to provide the Instructions-for-use (IFU) on their website

Short and helpful facts from the new MDR: PMS Plan

As a part of the technical documentation, manufacturer of Medical Devices will have to provide a Post-Market Surveillance plan. The PMS plan shall include, for example, the proactive process to collect any Information from serious and non-serious incidents, trend reporting, literature, feedback and complaints. Indicators and threshold values must be determined for continuous reassessment of risk benefit and risk management. Methods and tools must be described to investigate complaints or other experience from the field. All requirements for the PMS plan can be found in Article 84 and Annex III of the new MDR.

Economic Operators

The proposed European Medical Device Regulation (MDR) introduces the concept of the Economic Operators. An organization shall identify their roles undertaken in Europe. These roles can include Manufacturer, Authorized representative, Importer or Distributor. These terms were already introduced within the ISO 13485:2016. Articles 10 to 14 of the proposed MDR defines the obligations of these Economic Operators. The attached document provides a rough and generic overview of these obligations.

Short and helpful facts from the new MDR: PERIODIC SAFETY UPDATE REPORT

Short and helpful facts from the new MDR: Manufacturers of devices in class III or implantable devices shall submit the PERIODIC SAFETY UPDATE REPORT to the notified body involved in the conformity assessment. The notified body shall review the report and add its evaluation to the database with details of any action taken. Such reports and the notified body evaluation shall be AVAILABLE TO THE COMPETENT AUTHORITIES through the electronic system [EUDAMED]. You will find many new requirements for PMS in Article 86 and Annex III of the new MDR.

Short and helpful facts from the new MDR: PMS Report and PSUR

Manufacturers of class I devices will have to prepare a POST-MARKET-SURVEILLANCE REPORT summarizing the results and conclusions of the analyses of the gathered post-market surveillance data together with a rationale and description of any preventive and corrective actions taken. The report shall be updated WHEN NECESSARY and made available to the competent authority upon request. Manufacturers of devices in class IIa, IIb and III shall prepare a PERIODIC SAFETY UPDATE REPORT summarizing the results and conclusions of the analyses of the gathered post-market surveillance data together with a rationale and description of any preventive and corrective actions taken. Manufacturers of class IIa devices shall update the report when necessary and at least every TWO YEARS. Manufacturers of class IIb and III devices shall update the report at least ANNUALLY. Manufacturers of devices in class III or implantable devices shall submit the PERIODIC SAFETY UPDATE REPORT to the notified body involved in the conformity assessment. The notified body shall review the report and add its evaluation to the database with details of any action taken. Such reports and the notified body evaluation shall be available to competent authorities through the electronic system. You will find many new requirements for PMS in Articles 83-86 and Annex III of the new MDR

Typos in German translation of MDR 2017/745

Bedeutende Übersetzungsfehler in der deutschen Fassung der MDR 2017/745! Anwender der neuen MDR sollten beachten, dass es wohl mindestens zwei wichtige Übersetzungsfehler gibt: Annex IX, Abschnitt 5.1.a: "Bei Produkten der Klasse III ...." ist in der englischen Fassung: "For class III implantable devices...". Es wurde also das "implantable" vergessen". Annex VIII, Abschnitt 5.3, Regel 7: "sie sollen im Körper eine chemische Veränderung erfahren; in diesem Fall werden sie der Klasse III zugeordnet" ist in der englischen Fassung " are intended to undergo chemical change in the body in which case they are classified as class IIb". Es wurde also als Klasse III eingestuft anstelle von IIb! Im Artikel 14 wird fälschlicherweise vom "Importeur" gesprochen anstelle des "Händlers" ((2)letzter Ansatz). Falls ich mich irre bitte ich um Aufklärung

Table of content of MDR

MDR 2017/745 does not contain a table of Content. Feel free to download my ToC.

Basic UDI-DI

Unique Device Identifier (UDI) – Do you know the “Basic-UDI-DI”? The European Union introduced the UDI for medical devices as per MDR 2017/745. When looking into the details one may not expect too many differences versus the UDI introduced recently by the US FDA. However, some differences exist. Besides the main difference, that EU will use the EUDAMED database and US will use their GUDID database, another main difference is the “Basic UDI-DI”. The Basic UDI-DI is defined by MDR as “the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity” [MDR2017/745, Annex VI, Part C]. The Basic UDI-DI is to be seen as the access key to EUDAMED, i.e. the database where all UDI information will be held. It is important to know, that the Basic UDI-DI is different to the UDI-DI itself. The Basic UDI-DI will not be labelled on the packaging and will not be used in supply chain. It is more like a regulatory identifier and will be used in the Declaration of Conformity, Technical Documentation, Free Sales certificates and in the SSCP. The UDI-DI is to be included in the labelling and in EUDAMED. There are some more differences between the EU and US UDI. Active implants will have to bear the individual serial number in the UDI-PI in Europe, which is currently not required by FDA. The date format is a given in US (YYYY-MM-DD) whereas it is not defined in Europe. Some more differences, mainly product specific, can be found when digging into Annex VI of the MDR. So, better start reading now!

PMCF template

Currently there is no formal template from the European Commission yet how to conduct PMCF. Therefore I developped kind of template you may use.

SOP Post-Market-Surveillance (PMS)

MDR reminder: As per article 83 of MDR, manufacturers must establish a comprehensive post-market-surveillance System under their quality management system. Keep in mind, that ALL manufacturers must fulfill article 83 after May 2020, both under MDD and MDR! However, many manufacturers struggle to get this task accomplished. You will find therefore a SOP PMS on my webpage for download. Feel free to use it, but please provide Feedback about the experience you made using it.