Are you ready for MDR 2017/745?

What is the Medical Devices Regulation?

What are the differences with the directive MDD?

How much time will I have to adapt?

How can I train my employees?

...


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WHAT DOES THE NEW REGULATION MEAN?

After five years of discussions, the European Parliament has approved the texts of the new regulations which, inter alia, repeal the historic EC Directive 93/42 on medical devices. From this link you can download the full text in English of the REGULATION (EU) 2017/745.

The placing on the market of the devices will therefore have to meet the requirements of the new MDR (Medical Device Regulation), the transition period will last 3 years. The new regulation takes into account the specificity of the medical device, the stricter controls are combined with the need to protect the speed of innovation in its access to the market. 

A number of important innovations are therefore introduced:

  • Important new regulations for the supply chain with a clear definition and obligation to register economic operators, i.e. distributors, importers, agents and manufacturers;
  • Further provisions on manufacturers' responsibilities for monitoring the quality, performance and safety of devices placed on the market;
  • Stricter requirements for surveillance and clinical evaluation which will go beyond the MEDDEV 2.7/1 Rev. 4 guidelines on which they are based and which will severely limit the applicability of the concept of equivalence
  • Expansion of the types of devices subject to the regulations;
  • Profound transformation of OBL (own brand labelling) activities;
  • publication of common specifications which will accompany harmonised technical standards;
  • An obligation to identify a responsible and duly qualified person for compliance with the requirements of the MDR;
  • Greater transparency versus consumers and public information;
  • Creation of an EU portal to report serious accidents and corrective actions by manufacturers;
  • Stricter rules for the designation of notified bodies which will have more investigative obligations and whose activities will be monitored by the competent national authorities.
Medical companies will need to assess the impact of the new legislation on their activities as soon as possible (gap analysis), for some the transition will not involve particular efforts, for others profound changes and integrations will be necessary.

Eumed can support you in the gap analysis, implementation and training phases necessary to ensure your company's full legislative compliance.

Eumed consultants are available to analyze, even by video conference, your particular situation and to draw up an adaptation plan for your company in real time.


THE CURRENT SITUATION 

On Friday 17 April, during the plenary session, Parliament decided to approve the European Commission's proposal to postpone the application of the 2017/745 Medical Device Regulation for one year, postponing it to 26 May 2021. The choice was made to allow competent authorities and manufacturers to concentrate their efforts in the fight against COVID-19 and to avoid a lack of stocks or delays in the production of essential medical devices on the market. The proposal will now have to be approved by the Member States and will be published in the Official Journal (GUCE) before the date of application of Regulation 745, which was scheduled for May 26, 2020. 

The extension does not concern Regulation 2017/746 on in vitro diagnostic medical devices, whose application remains scheduled for May 26 2022.


Thursday 23 April 2020 the European Council approved and made official the one-year extension of Regulation on medical devices. Regulation 2020/561 relating to the new dates of application of the provisions of Regulation 2017/745 has been published in the OJEC.


EUDAMED - Actor Registration Module 

On 20th of October 2020 the EU Commission published online the new webpage dedicated to the Action Registrarion Module in Eudamed (link). 

Manufacturers, both EU and non-EU, importers, authorized rapresentatives, sistem and procedure pack producers, have to register in this new database, which is planned to be functional by december 2020.


--> 1° December 2020 

THE NEW ACTOR REGISTRATION MODULE (EUDAMED) IS NOW AVAILABLE! 

The EU Commission has made available the actor registron test module.  

If you are:

- EU or extra-EU manufacturer
- system/procedure pack producer

- authrized representative

- importer 

You can create your EU login account and register in Eudamed: after the national competent authority has approved your request, you will receive your SRN (single registration number) ad economic operator.
You will be able to manage your account and users and to test the module before it will be definitely operational. 

Here you can find the EUDAMED public and the EUDAMED restricted.


INSIGHTS

Currently Notified bodies designated for Regulation 2017/745 :

  1. IMQ Istituto Italiano del Marchio di Qualità Spa (Italy)
  2. BSI UK (England)
  3. BSI Group The Netherlands B.V. (Netherlands)
  4. DARE!! Service B.V. (Netherlands)
  5. DEKRA Certification GmbH (Germany)
  6. DEKRA Certification B.V. (Netherlands)
  7. TUV Rheinland LGA Products GmbH (Germany)
  8. TUV SUD Product Service GmbH Zertifizierstellen (Germany)
  9. DNV GL Presafe AS (Norway)
  10. MEDCERT (Germany)
  11. NSAI (Ireland)
  12. CE Certiso Orvos (Hungary)

Transitional provisions
A corrigendum of the regulatory text, which will modify the article 120 on transitional provisions, has been approved. In particular, an extension is provided for devices that require a certificate in accordance with Regulation while it was not required by Directives 93/42 and 2007/47: for example class I reusable devices (surgical instruments).

Reconditioning and reuse of single-use medical devices

It is expected the first draft of common specifications.


UDI (Unique Device Identifier)
Specifications are still expected from the Commission about:
  • Recognition coronation of the Italian CND classification as the official nomenclature herarchy of the elements of the basic UDI-DI,
  • Data values for the UDI,
  • Changes to data involving a new UDI-DI and a new basic UDI-DI,
  • Helpdesk for UDI and Eudamed: establishment of the single European support centre for Eudamed and UDI for stakeholders,
  • Guidelines for devices combined with medication (MDR art.1(8),1(9), and 1(10),
  • Guidelines on the control of UDI labelling within the manufacturer's QMS,
  • Guidelines on the UDI carrier and its marking with illustrative examples based on the work of the IMDRF,
The bodies designated to issue UDI codes are: GS1, HIBCC, ICCBBA and IFA.
The documents of the Release Bodies designated on the application of the basic UDI-DI and on the use of HRI and AIDC formats have been published on the Commission's website (Link to the page).

At the moment the application of the unique device identification system (UDI) has not been subject to extensions, therefore the UDI obligations remain valid according to the application dates defined in article 123 of the Regulation:
  1.   Class III implantable devices: from 26 May 2021
  2.   Class IIa and IIb devices: from 26 May 2023
  3.   Class I devices: from 26 May 2025
For reusable devices that carry the UDI carrier on the device itself, additional 2 years are added to the date set for the corresponding risk class.

EUDAMED (European database)
Eudamed is the new European database that will incorporate a large number of functions foreseen by the Regulation (EU) 2017/745.
It will be the platform used for the registration of economic operators and medical devices, for the exchange of information and for the collaboration between the parties, for the notifications of events, accidents, reports and communications. It will also become the tool for disseminating information to the public, made by private parties and freely parties accessible by the public.

EUDAMED will be made by 6 interconnected modules:
  1. Actors registration;
  2. UDI / Devices registration;
  3. Notified bodies and Certificates;
  4. Clinical investigations and performance studies;
  5. Vigilance and post-market surveillance;
  6. Market surveillance.
The development of a database that is expected to be so rich in data and related systems is certainly a complex and delicate operation, especially considering the sensitivity of the data processed.
The European Commission is currently working, through working groups (MDCG - Medical Device Coordination Group) and specifically dedicated experts, to define the functional specifications of Eudamed and therefore to develop a solid architecture capable of providing the required performance.

As published on the Commission's website dedicated to the new database and by the MDCG document 2020-15, it was decided (unlike what was initially planned to make Eudamed operational only when all 6 modules would be functional) that the individual Eudamed modules will be released gradually when they are ready. The first module which is expected to be operational is that relating to the registration of economic operators, scheduled for December 2020. Subsequently, the modules on UDI / devices registration and on Notified bodies and Certificates will be completed (May 2021), then the remaining modules as soon as available.

Economic operators have to obtain a single registration number (SRN), generated through the Eudamed registration module and issued by the competent national authorities. An SRN must be requested for each role covered (e.g. 1 SRN as manufacturer and 1 SRN as importer): the SRN will be the access key of each operator to Eudamed. 

One of the problems related to Eudamed concerns the access mode, provided through the UDI code. However, the so-called legacy devices (devices that can be marketed pursuant to certificates of conformity to the 93/42 / CEE and 90/385 / CEE Directives that are still valid) are not subject to the UDI obligation, which is why to allow the registration of these devices two different unique "keys" have been announced for access to the database (IDs): the Eudamed DI (corresponding to the basic UDI-DI) and the Eudamed ID (corresponding to the UDI-DI). 


Therefore, applying the transitional provisions of article 123 it is clear that:
The obligation to register in EUDAMED the data on the devices listed in Annex VI (part A, point 2 and part B) will be applicable after 24 months from the date of notice on the EUC of the operation of Eudamed (6 months + 18 months) because Eudamed will not be operational by May 26, 2020.

REPROCESSING OF SINGLE-USE DEVICES

On August 19th the Commission implementing REGULATION (EU) 2020/1207 has been published, as required by article 17 of Regulation (EU) 2017/745 (par. 5).  This regulation contains the common specifications (SC) for the reprocessing of single-use devices.

The reprocessing of single-use devices is possible only if permitted by national law and it must ensure that the safety and performance of the refurbished device is equivalent to that of the original device.
The ‘reprocessor’means the health institution and the external reprocessor reprocessing single-use devices. Both health institutions and external reprocessors shall establish, document, implement, and maintain a Quality Management System for the reprocessing activities, including a traceability system and a an incident reporting system.
Reprocessors shall designate one or more persons responsible for the reprocessing: a preliminary assessment of the suitability of a single-use device for reprocessing is needed and technical documentation must be prepared.
The reprocessor must define the reprocessing cycle and the maximum number of reprocessing cycles.


CLINICAL INVESTIGATIONS (GCP)
The publication of a new version of the ISO 14155 standard is expected.
There are also expected guide lines on:
  • Summary of Safety & Clinical Performance,
  • The concept of equivalence,
  • The definition of "sufficient" clinical data

MARKET SURVEILLANCE AND VIGILANCE
  • New mandatory form from January 2020: Manufacturer Incident Reporting Form (MIR - link),
  • The forms to be used for the reports can be downloaded at the following link,
  • Electronic reporting (Eudamed Electronic Reporting): Field Safety Corrective Action (FSCA), Field Safety Notice (FSN), Periodic Summary Report (PSR), Periodic Safety Update Report (PSUR) and Trend Report will be transmitted via electronic systems, from when these will be made operational on Eudamed,
  • An addition to the Meddev 2.12-1 rev. Guideline has been published 8 for Supervision: link,
  • Device Specific Vigilance Guidance: new guidelines for breast implants, electronic cardiac implants, insulin infusion pumps and integrated measurement systems.

Software
  • Definitions and classification: publication of the MDCG guideline on the definitions relating to software in the regulations and how to assign the correct risk class, downloadable from the following link,
  • Clinical evaluations: publication of MDCG guidelines on the clinical evaluation of software (link),
  • Cybersecurity: publication of the MDCG guidelines on the requirements for cybersecurity (link).

Phthalates
The guideline of the Scientific Committee for health, the environment and emerging risks (SCHEER) on the evaluation of the risk-benefit ratio of phthalates was published, as indicated in section 10.4.3 of Annex I of the MDR.
The guideline can be downloaded at the following link.


LABELLING AND ISTRUCTIONS FOR USE
  • IFU: the revision of the Regulation 207/2012 is expected for the instructions for electronic use for medical devices,
  • Implant card - MDCG guideline on the content of the card for the implant bearer,
  • MDR symbols: the revision of the ISO 15223-1 standard is being prepared, it will contain more symbols according to new requirements of Regulation.

HOW TO STAY UPDATE

On the Commission's website there is the Topics of interest section where you can find updates on:

1. Notified bodies,
2. Eudamed and UDI,
3. Software and apps,
4. In-house medical device,
5. Customized devices,
6. Financing,
7. Innovative Medicines Initiative (IMI),
8. Brexit.

On the Guidance page you will find all the documents published by the MDCG group to support stakeholders in the application of the Regulation.

For updates on the European database, consult the dedicated EUDAMED page.