Thursday, July 14, 2016 —
40 experts and leaders from the plastics medical device and pharmaceutical packaging industry met at the Hilton Hotel Strasbourg for the 2016 MedPharmPlast Europe Conference.
This year's focus lied on the Medical Device Regulation, its implementation and implications for the complete value chain, and how MedPharmPlast Europe assists its members by providing valuable information regarding the implementation process.
The session started with a state of the art presentation on the MDR given by Adrian Bartlett from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. As key issues he emphasised among others the compromise on hazardous substances, Eudamed and the unique device identification (UDI), the role of the Notified Bodies and pre-market scrutiny. The next paper by Peter Curle from Ernst & Young highlighted the consequences of the MDR for the relationship between suppliers & converters.
"The new EU MDR will have far reaching impacts for its many stakeholders and will be transformational for the industry" - Peter Curle, Ernst & Young
As key consequences for the EU market, Curle emphasised that the costs to operate will increase and that the EU markets as ‘first to launch’ markets might be less attractive during the transition period. Referring to the regulatory landscape, he outlined that the clear and detailed rules imposed by the regulations will not give room for divergent transposition by Member States, that the introduction of an ‘expert panel led’ scrutiny process will represent a significant change, and that also the impact on the Notified Bodies will be substantial. When it comes to the economic impact for the business, according to Curle, substantial costs to remediate will be anticipated and a complex change programme within companies will become necessary whilst maintaining ‘business as usual’.
The morning session was then concluded by an overview presentation on the activities of the Regulatory Task Force within MedPharmPlast Europe. Nigel Talboys from Terumo BCT and chairman of the task force outlined the current priority activities on the implementation of the Medical Device Regulation, Titanium Dioxide, Endocrine Disrupters, Nanomaterials and DEHP. Among others, the group is currently finalising position papers on the MDR as well as on TiO2, which will be used for the advocacy work of MedPharmPlast Europe on European level.
The afternoon session comprised presentations on 3D printing by Ward Callens from Materialise, market data and trends in the plastics medical device industry by Antonella Lisella from Frost & Sullivan, the changes in testing requirements related to the revision of the USP <661> and comparison to European Pharmacopoeia by Frank de Smedt from Toxikon, as well as an overview presentation on the European network of MedPharmPlast Europe given by Beatrice Grand Demars from Nemera.
The next MedPharmPlast Europe event will take place on 29 November 2016. For more information on MedPharmPlast Europe activities, events, membership and the support that our sector group can offer your company, please contact Eva Schneider, Communications Officer, via firstname.lastname@example.org.