New MDR & IVDR – Key Timelines & Regulatory Documents

From Directive to Regulation meaning that it will now be enforceable by law in all Member States.

Three Medical Device Directives evolve into two Regulations:

  • Medical Device Directive (MDD) & Active Implantable Medical Device Directive (AIMD) are now covered by one Medical Device Regulation (MDR): Date of application = 3 years after entry into force i.e. 26 May 2020
  • In-Vitro Diagnostics Directive (IVDD) is now covered by In-Vitro Diagnostics Regulation (IVDR): Date of application = 5 years after entry into force i.e. 26 May 2022

MDR [Regulation (EU) 2017/745] – Contents:

  • Part A: Introduction – Reasoning
  • Part B: Main content (10 Chapters of 123 Articles)
  • Part C: Guidelines & Examples – XVII Annexes

Some Key Regulatory and Medical Documents required:

  • Clinical Evaluation Reports (CERs): Increased stringency and frequency of updates for certain classes [MDR Article 61].
  • Clinical Trial Documents: Due to increased clinical trials required for CE marking and/or recertification, it will be expected to submit more clinical investigation plans and reports (i.e. study protocols and reports) [MDR Articles 61 & 62].
  • Post-marketing documents: Post-market surveillance plans [MDR Article 84] and reports [MDR Article 85] will need to be submitted for all classes.
  • Periodic Safety update reports (PSUR): For Class IIa devices, PSURs will need to be submitted every 2 years and annually for class IIb and III devices [MDR Article 86].
  • Summary of safety and clinical performance (SSCP): For implantable devices, class III and other investigational devices, it will be required to submit SSCP which will be available to the public and therefore, prepared accordingly for the attention of the intended device user and/or patient [MDR Article 32].

Please note that many important changes which are not within the scope of this article have been implemented with the new regulations. Key opinion leaders predict that some changes will in turn show a great impact on how devices are marketed and some other changes which are currently described as unpredictable may further disrupt the medical device market.

Niconex Medical will remain constantly updated with developments to provide complete regulatory and medical support should it be required.

Valletta Declaration – Patient Access & Health Sustainability

Ensuring patient access to innovative medicines and therapies while maintaining sustainability of health systems has led to the Declaration of Valletta signed by Health Ministers of Cyprus, Greece, Italy, Ireland, Malta, Portugal, Romania and Spain.
The initiative has demonstrated a commitment to elucidate new collaborative avenues in various areas including: 
  • Information sharing
  • Best practice identification
  • Horizon scanning of innovative medicines and therapies 
  • Possible mechanisms for price negotiations
  • Potentials of joint procurement
A Technical Committee comprised by three representatives from each of the aforementioned EU Member States to study the above possibilities had its first meeting on Thursday, 29th June 2017 in Cyprus. Such evolving relationships between Member States promote a central focus on securing affordable access for patients to innovative medicines.
Ongoing developments will be posted in due course. For details regarding our services please follow the link below or contact us. 

National Health System Cyprus

The parliament of the Republic of Cyprus unanimously passed government bills and regulations introducing the national health system (GESY).

One government bill includes the creation of an organisation that will oversee the autonomous state hospitals and another harmonising the original GESY law with European Union requirements, plus a set of ordinances regulating labour issues and contribution rates.

The National Health System in Cyprus will now embark on a journey of gradual adaptation with a deadline of complete implementation set at July 1, 2020.

Ongoing developments will be posted in due course. For details regarding our services please visit Niconex Medical website or contact us. 

Courtesy of the Health Insurance Organisation.

Video reference:

CPhI Worldwide 2017

Niconex Medical is attending  CPhI Worldwide 2017 with aim to visit and meet with global partners, fellow pharma peers and stay updated on the latest industry trends. 

Please do not hesitate to contact us if you would like to schedule a meeting.

EuDRAcon Conference 2017

Niconex Medical participated in the EuDRAcon conference for 2017 of the pan-European network of Drug Regulatory Affairs consultancy companies, hosted by Ivowen Limited in Ireland. We had the opportunity to share many discussions including:

  • an overview of local requirements specific to Cyprus (MAAs, PV, fees, pricing and reimbursement),
  • a summary of a recently successful Article 29 referral to the CHMP
  • Electronic submission roadmap
  • Substance, Product, Organisation, Referential (SPOR)
  • Regulatory Optimisation Group of HMA – background and work plan
  • BREXIT – what it means to us

The conference for 2017 was additionally marked with an honour and a privilege for Niconex Medical to become a EuDRAcon member as the representative company from Cyprus.  Our sincere appreciation towards all partner companies.

New EudraVigilance System

The European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). The new version of EudraVigilance will go live on 22 November 2017 with enhanced functionalities for reporting and analysing suspected adverse reactions.

Time to train and prepare for implementation of the NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format.

The complete EMA official announcement can be found here.