NEW EU Medical Device Regulations – EMDR 2016 – Live Webinar Training


NEW EU Medical Device Regulations 2016-Live Webinar 

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Duration: 50 min. + 10 min. Questions Time.

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Regulation 745/2017 on Medical Devices: technical file structure

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Description:

This live webinar course will provide guidance on the new requirement introduced with NEW EU Medical Device Regulation.

In Particular will discuss the following points:

  1. Main New Requirements
  2. (UDI) Unique Identification number
  3. Post market activities
  4. New Technical File
  5. Transition from current  to the new regulation 

The agreed two draft regulations are expected to achieve a twofold aim: making sure that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit of innovative health care solutions in a timely manner.

Medical devices and in vitro diagnostic medical devices cover a wide range of products, from sticking plasters to hip replacements, and from pregnancy tests to HIV tests.

Why You Should Attend:

On May 25, 2016, the various European Union (EU) negotiators have finally reached a deal (four years in the making) on new rules for medical devices and in vitro diagnostic medical devices. This was unexpected and, although formally there are a couple of further procedural steps, companies active in this space should now assume that the rules are final and will be in force in 2016 (but subject to delayed implementation).  In addition to the twenty-eight EU countries, five other countries will be covered by the rules (including Norway, Switzerland, and Turkey).

The Netherlands presidency of the Council and representatives of the European Parliament reached a political agreement. It is still subject to the approval by the Council’s Permanent Representatives Committee and of the Parliament’s ENVI committee.

“This agreement matters to all citizens: sooner or later all of us enter into contact with medical devices to diagnose, prevent, treat or alleviate diseases. The deal reached will improve patients’ health and it will help to enhance the quality of life of disabled persons. It will also ensure a level playing field for the 25 000 medical devices manufacturers in the EU, many of which are SMEs and which employ more than half a million persons”, said Edith Schippers, Minister of Health of the Netherlands and President of the Council.

Strengthening the system

The agreement reached seeks to ensure the safety of medical devices by two means: by strengthening the rules on placing devices on the market and tightening surveillance once they are available.

The agreement will further tighten the rules for the independent bodies that are responsible for assessing medical devices before they can be placed on the market. The new rules will strengthen the surveillance of these so-called notified bodies by national authorities. They will also give these bodies the right and duty to carry out unannounced factory inspections. Notified bodies will have to ensure that they have available qualified personnel.

The draft regulations establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market. This will allow manufacturers to act swiftly when concerns arise and help them to improve their devices continuously on the basis of actual data. Manufacturers and other economic operators will have clear responsibilities, for instance on liability, but also on registering complaints on devices. The draft regulations also improve the availability of clinical data on devices. The protection of patients participating in clinical investigations will also be strengthened.

Strengthened rules for high risk devices

Certain high risk devices, such as implants, may undergo an additional check by experts before they are placed on the market. Expert panels and laboratories will play a key role in supporting the legislative system, to provide expertise and guidance on clinical aspects to notified bodies, competent authorities and to manufacturers.

The new EU rules also explicitly cover certain devices without a medical purpose but with similar characteristics as medical devices. This concerns for instance  fillers and coloured contact lenses for cosmetic purposes.

More transparency for patients and increased traceability

A central database will be set up to create an improved system for all relevant information. It will cover economic operators, notified bodies, market surveillance, vigilance, clinical investigations and certificates. In addition, it will provide patients, healthcare professionals and the public with comprehensive information on products available in the EU. This will enable them to make better informed decisions. Patients who are implanted with a device will be given key information on the product, including any precautions which might need to be taken.

Devices will have a unique identification number to provide for traceability throughout the supply chain to the end-user or patient.

Next steps

The Council’s Permanent Representatives Committee will be invited to endorse the agreement probably mid-June 2016. Once the Parliament’s ENVI committee has also confirmed that it can accept the compromise the Council will be invited to confirm the agreement. Following the revision of the texts by the lawyer-linguists the two regulations will have to be formally adopted by the Council and the Parliament. The new rules will apply three years after publication as regards medical devices and five years after publication as regards in vitro diagnostic medical devices.

Here are some specific highlights:

  • The rules will further tighten the rules for the independent bodies that are responsible for assessing medical devices before they can be placed on the market (the so-called “notified bodies”).
  • The rules will also give these bodies the right and duty to carry out unannounced factory inspections (this is something that is happening already and companies need to be prepared for this type of “dawn raid”).
  • The rules on manufacturers’ responsibilities for follow-up set out clear responsibilities, for instance on liability, but also on registering complaints on devices.
  • The rules improve the availability of clinical data on devices. The protection of patients participating in clinical investigations will also be strengthened.
  • Controversially, certain high-risk devices, such as implants, may undergo an additional check by experts before they are placed on the market. Also, expert panels and laboratories will play a key role in supporting the legislative system, to provide expertise and guidance on clinical aspects to notified bodies, competent authorities, and to manufacturers.
  • Patients who are implanted with a device, will be given key information on the product, including any precautions which might need to be taken.
  • Devices will have a unique identification number (UDI) to provide for traceability throughout the supply chain to the end-user or patient.

As mentioned, all companies in the space in the EU need to start preparations if they were not doing so already. It may not seem like it, but time is actually quite tight.  

Who Will Benefit:

  • Quality Manager
  • Quality Engineers
  • Design Quality
  • Regulatory Affairs specialist
  • Medical Affairs specialist
  • Clinical Affair specialist
  • R&D Engineers
  • Marketing

 

Certification Requirements:

Students must view the entire program and successfully pass an online, multiple choice final assessment with >80% passing grade.Certificate will be printable in PDF format immediately after satisfying requirements.

 

Online Training Programs Includes:

  • Answer to questions submitted during the webinar.
  • An online final assessment with multiple choice questions.
  • A Certificate of Completion.

 

Live Course Presented and Commented by:

2adc791[1]Alice Ravizza is a Biomedical Engineer, graduated at Politecnico di Milano. She has great and extensive experience in R&D and QA / RA in the biomedical field. She is specialized in supporting Medical Device companies in building up and improve Quality System Management and assure Compliance through all the internal processs. She assist companies during the registration process for CE Mark making sure all the technical documentation is compliant to applicable standards and regulations. She is aswell an experienced Trainer and Lecturer.

 

Early bird booking Promotion:

Register now and get 25% Off!! – (Valid until 10/07/2016). Send email to info@mdpharmacourses.com to get the discount code.

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