EU Regulatory Essentials, Medical Device and In Vitro Diagnostics: Transitioning from Current Directives to New Regulations

This one-and-a-half-day workshop is based on the highly-regarded and consistently sold out EU workshop at RAPS Regulatory Convergence. Offered for the first time in Europe, the workshop will examine the current directives, and focus on the new EU regulatory expectations for medical devices and IVDs as introduced by the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).

This is a can’t miss opportunity to learn from experienced regulatory affairs professionals who are closely engaged with the new emerging EU regulatory requirements. They will share important insights, unique perspectives and address the challenges of the new regulations. There will be two general sessions relevant to all device/IVD manufacturers supplemented with two comprehensive tracks that delve deeper into the specifics of the new MDR and IVDR. The tracks will dig into new classification, conformity assessment, safety and performance, clinical/performance evaluation, technical documentation and postmarket requirements.

By the end of the workshop, you will be aware of the key changes introduced by the new regulations. You also will receive expert interpretation of new expectations and be prepared to develop transition plans to navigate market access (CE Marking) expectations for both new and legacy devices being placed in Europe. If you are working in medical device/IVD regulatory affairs and quality assurance, this workshop will be invaluable.

Join us.




  • At a Glance
  • Objectives & Audience
  • Agenda
  • Speakers
  • Registration Info
  • Cancellation

At a Glance

Date:

4 July 2017 ¦ 10:00 –17:30 CET
5 July 2017 ¦ 09:00 –12:30 CET

Location:

Sofitel EU Brussels
Place Jourdan 1, 1040
Brussels, Belgium

Directions are available online or by calling +32 2 235 51 00

Registration Closes:

27 June 2017

Refund Deadline:

5 June 2017 

RAC Credits:

Will this meeting be recorded?:

No 

Proof of Attendence:

An electronic letter of attendance will be sent upon request.

Registration Fees:

(All fees in US dollars. Euro equivalents are shown for reference only, and are subject to exchange rate at time of registration.)

Prior to 31 May   
RAPS Members: $850 (approx. €800)
List: $950 (approx. €900)                                                            

 

1–27 June   
RAPS Members: $950 (approx. €900)                                                             
List: $1,050 (approx. €990) 

NOTE: Seating is limited to 75 people. Advance registration is required; no onsite registration is available. Register early to secure a seat.

Objectives & Audience

At the conclusion of this program you will be able to:

  • Contrast current European top-level regulatory requirements for devices, such as Active Implantable Medical Device Directive (AIMD), Medical Device Directive (MDD) and In Vitro Diagnostics Directive (IVDD) and the new requirements Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR)
  • Describe what is expected to follow the MDR/IVDR in delegated acts
  • Identify requirements for transitioning CE marking from the directives to regulations

Those in the MDD/MDR track, after hearing all the presentations and participating in discussions, should be able to:

  • Describe the current rules based process for classification of devices under the MDD/AIMD and changes introduced by the MDR
  • Compare the routes to CE marking and conformity assessment under the MDD to the MDR and the value of ISO 13485
  • Summarize the MDD Annex I essential requirements and the changes introduced by the MDR Annex I general safety performance requirements
  • Differentiate between current clinical requirements under the MDD and the new paradigm under the MDR
  • Explain the best practice technical documentation for complying with MDD and the MDR
  • Identify how to address postmarket requirements under MDD and additional MDR expectations

Who Should Attend

Intermediate level staff and regulatory affairs staff responsible for interpreting EU medical device regulations and practicing effective implementation. Included those responsible for correctly classifying devices, preparing technical files, conducting clinical evaluations and postmarket activities. The workshop is ideal for those who need to confirm best practice against current requirements and who are preparing gap assessments to effectively plan transition to compliance with new regulations.

Agenda

Tuesday, 4 July

10:00

Registration

 

10:30

Welcome

 

 

10:40

The EU Medical Device Legislative Framework: the Current ‘New Approach’ Directives and the Evolution to the New Regulations [Joint MD & IVD Session]

 

11:25

EU MDD/MDR Track

Classification Concepts and Up Classifications; Products Newly Covered Under the Regulation

EU IVDD/IVDR Track

Classification Concepts and Up Classifications; Products Newly Covered Under the Regulation

12:30

 

Lunch break

 

13:30

Conformity Assessment Now and Then

Conformity Assessment Now and Then

14:15

MDD Essential Requirements to MDR General Safety and Performance Requirements (Including Labeling)

IVDD Essential Requirements to IVDR General Safety and Performance Requirements (Including Labeling)

15:00

Refreshment Break

15:15

Clinical Requirements Under the MDD and the New Paradigm Under the MDR

Performance Evaluation Requirements Under the IVDD and the New Paradigm Under the IVDR

16:45

Roundtable Discussions

Roundtable Discussions

17:30

 

End of Day 1

 



Wednesday, 5 July

09:00

EU MDD/MDR Track

EU IVDD/IVDR Track

Technical Documentation for Compliance

Technical Documentation for Compliance

10:00

Postmarket Expectations,
Including Postmarket Clinical Follow-up

Postmarket Expectations

10:45

Refreshment Break

11:15

Additional Regulation Requirements, Scrutiny and Consultations, Implementing and Delegated Act; Transition Timing [Joint MD & IVD Session]

12:15

Outlook / Q&A / Closing Remarks

12:30

Adjourn

Speakers

See Speaker Bios

Registration Info

(All fees in US dollars)
 
Prior to 31 May
RAPS members: $850
List: $950 

1–27 June
RAPS members: $950
List: $1050

>> Registration Online

>> Registration Form (PDF) – for registration by mail or fax.

Registration Closes: Advance registration (online, mail, and fax) will be accepted until 27 June 2017 unless meeting capacity is reached; after 27 June, please contact RAPS Solutions Center at +1 301 770 2920, ext. 200 or  raps@raps.org registration options.

Refund Deadline: 5 June 2017

Other Information

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

Questions? Call RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org.

Program Contact

Wessel Nieuwenweg
wessel@newway-management.com
+33 9 67 62 61 04

Hotel Information

Sofitel EU Brussels
Place Jourdan 1, 1040
Brussels, Belgium
Hotel Phone: +32 2 235 51 00
E-mail: H5282@Sofitel.com

Set in the heart of Brussels, in direct connection to the Grand Place, next to the European District, Sofitel Brussels Europe is a truly elegant hotel, ideally located on the vibrant Place Jourdan, one of the last typical Brussels atmosphere square. Close to the famous Cinquantenaire parc and musea, the hotel offers the best location for all trips. Enjoy the traditional food market on Sundays and the typical "Ambiance Bruxelloise."

Room Rate Accommodation

RAPS has negotiated a dedicated room allotment directly at the Sofitel Europe Brussels Hotel,  beneficial rates will be offered to workshop participants. In order to benefit from special rates, delegates are encouraged to book directly by using the following booking and reservation formor by contacting julie.leleu@sofitel.com (Tel: +32 2 235 51 15).  Reservations made directly online via the hotel website or any alternative booking service sites will unfortunately not benefit from preferential rates.

Access & Public Transport

The Sofitel Brussels Europe hotel is located in the “QUARTIER SCHUMAN” and SCHUMAN STATION is the closest public transport hub, conveniently located at only 800 meters (0.5 miles) from the hotel. 

Schuman Station is serviced by Metro, bus and train. 

Schuman Station can be reached by Metro (subway) Line 1 as well as buses 11, 12 and 28.   Alternatively buses 60, 80, 59, 34 stop directly at Place Jourdan-Rue Froissart.

Coming from the city centre the closest tram stop is ‘Chasse’ and is serviced by line 81 and 82.

For real time information, you can visit the mobile website m.stib.be or download the STIB app for iPhone or Android (available in English).

Parking

For participants driving to the hotel, the hotel has a private parking facility available.

Taxi

Taxis are available directly from the airport upon arrival and participants are encouraged to follow the official taxi signage and use officially authorized taxis from the airport.  Two options for taxi companies for travel within the city are: TAXI VERTS (T: +32 2 349 49 49) or TAXI BLUES (T: +32 2 268 00 00). 

 

 

 

 

Cancellation

All cancellation requests must be submitted to raps@raps.org by 5 June 2017. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed. 

Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 5 June 2017. 

If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.

NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.