Regulations and Brexit features at MedPharmPlast event

MedPharmPlast Europe welcomed more than 50 industry experts during a two-day event in Frankfurt.

It was organised in collaboration with Clariant and Sanofi and offered industry presentations.

Day 1 focussed on regulations, REACH, IPAC-RS and MedPharmPlast Europe's activities

Frank De Smedt from Nelson Labs gave an update on the changes to USP, EP and ISO, with two presentations on each day decided to the Medical Device Regulation.

As MPPE is involved in the Medical Device Coordination Group, Patrick De Kort gave an update on behalf of Pascale Van Hoydonck (Terumo) with insights regarding the required Commission EU MDR technical guidance. 

Nathalie Bujis from Medtech Europe presented about the implementation of the MDR requirements on CMR & endocrine disrupting substances, and another presentation about the issues of the REACH restriction proposal on microplastics in the medical technology sector.

The audience also heard how SABIC differentiates its engineering resins with extractable and leachable data from Hans De Brouwer and an update from Gaby Reckzügel (Boehringer Ingelheim Pharma) about the baseline requirements for materials in contact with drug products – recommended by IPAC-RS.Also, Steve Duckworth MPPE president presented the goals and activities of MedPharmPlast Europe.

Day 2 of the conference saw views on MDR, Brexit update and nanomaterials under REACH, and was held in the Clariant Innovation Center (CIC).

Presentations focussed on the Medical Device Regulation. Lars Petersson, Clariant gave the view of a raw material supplier on the MDR. Afterwards Bassil Akra (TÜV) gave insights from the other end of the value chain about the view of notified bodies on the MDR implementation.

Also, Nigel Talboys from Terumo explained the biggest challenges and possible outcomes of Brexit, while Heike Liewald shared Eurocolours' view on the nanomaterial definition, nano under REACH Regulation & EU nano-observatory. She stressed that there are many challenges regarding the regulatory requirements for the pigment & fillers industry. 

The next MedPharmPlast Europe event will take place on 17 December 2019, with details to be announced.