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Workshop on “Medical Devices Regulations in EU & UK”



PXL/HO/Cir-020/2024-25                                                                            Date: 28.05.2024



Dear Sir, 

Sub: Workshop on “Medical Devices Regulations in EU & UK” 


We are pleased to inform that Pharmexcil in association with MT Promedt Consulting GMBH (Germany based regulatory consultancy) is organising a Workshop on “Medical Devices Regulations in Europe” to help Indian companies to make their inroads into the European market. The workshop is proposed on 14th June 2024 in Hyatt Place, Banjara Hills, Hyderabad and is supported by Telangana Life Sciences, AMTZ, AiMED & FICCI.


Workshop on “Medical Devices Regulations in Europe”

Date: 14th June 2024 (Friday)

Time:  (9.30am- 2.00pm)

Venue:Hyatt Place, Banjara Hills, Hyderabad


Topics Covered in Workshop

Introduction to Medical Devices Regulation:

Ø  Explanation of the regulatory framework MDR (“The way to CE mark”, EU

Ø  Authorized Representative, UK RP)

Ø  Overview of different regulatory bodies (e.g. EU MDR in Europe, MHRA in UK)

Ø  General structure for Technical documentation according to MDR

Ø  Clinical Evaluation Process for medical devices (Clinical data, Equivalence, Literature Research)

Ø  Explanation of device classification systems (e.g., Class I, IIa, IIb, III in Europe & UK).

Ø  Factors influencing classification (e.g., intended use, risk to the patient).

Ø  Biocompatibility for medical devices


Regulatory Compliance :Challenges and Case Studies:

Ø  Common challenges in achieving regulatory compliance.

Ø  Overview of consultancy services, training programs, and regulatory agencies.


Click Here to Register:

Workshop on Medical Devices Regulations in Europe & UK- Registration Form (google.com)



Entry Fee

There is no participation Fee, but registration is mandatory 


Members dealing with Medical Devices may kindly join the Workshop & understand the regulatory requirements of Europe.  For any further enquiries, please write to regulatory@pharmexcil.com





Udaya Bhaskar

Director General