mdi Europa GmbH

20/07/2019

Bfarm Recommendation on Paclitaxel-coated Stents and Balloons

The German Federal Institute for Drugs and Medical Devices, recently published a warning notice for patients, users and manufacturers of stents and balloons that are coated with Paclitaxel.

20/07/2019

EU authorities contemplating reviewing products if shortage of NBs put product accessibility in jeopardy

It seems that the medtech system is on course for calamity because notified body designation under the new EU medical devices regulations is so slow that a tailback in notified body reviews is certain.

Offering CE-marking and approval services for medical devices, e. g. MDD, IVDD, MDR, IVDR etc. and EU Authorized Representative services per EU Directives.

20/07/2019

EU guidance on quality rules for drug-device combinations

The long overdue guidance on quality expectations for regulatory filings in the EU concerning integral and other kinds of drug-device combination (DDC) is available in draft form for public consultation.

20/07/2019

Guidance on Implant Cards

The Medical Device Coordination Group (MDCG) has recently published a useful guidance on the Implant Card (IC) according to article 18 of the MDR.

Guidance on Person Responsible for Regulatory Compliance

The Medical Device Coordination Group (MDCG) has recently published a useful guidance on the “Person Responsible for Regulatory Compliance” (PRRC) according to article 15 of the MDR and IVDR.

20/07/2019

Updated clinical evaluation guidance on comparability

In an effort to bring its guidance documents on clinical evaluation up to date, the International Device Regulators Forum has asked for feedback on proposed revisions to three documents, including how to demonstrate equivalence to comparable devices.

Updated standards on packaging for terminally-sterilised medical devices

New versions of the ISO 11607 series of standards on packaging for terminally-sterilised medical devices have been finalised.

20/07/2019

No upsets anticipated in EU quality guidance for drug-device combinations (DDC)

The eagerly-awaited draft guidance on quality expectations for EU marketing authorisation applications for integral and other types of drug-device combinations is unlikely to hold any upsets and should be issued the first week in June.

20/07/2019

Swiss medical device manufacturers under pressure

There is continuing doubt about the outcome of the Institutional Agreement Switzerland negotiated with the EU hence the advice from Switzerland’s medtech industry association to begin considering preparing to meet third-country requirements with regards to marketing products in the EU.

20/07/2019

Preliminary guidelines on phthalates in medical devices

Companies wishing to sell a medical device having phthalates in Europe should be familiar with the consultation published by the European Commission on this subject.

20/07/2019

Second notified body designated under the MDR

Germany’s TÜV SÜD has become the second notified body, following BSI UK, to become officially designated under the EU’s Medical Devices Regulation (2017/745) and the Commission’s Nando database on notified body was brought up-to-date accordingly on May 22.

Offering CE-marking and approval services for medical devices, e. g. MDD, IVDD, MDR, IVDR etc. and EU Authorized Representative services per EU Directives.

20/07/2019

LRQA to Withdraw Notified Body Services

The UK Notified Body LRQA will not apply for designation under the MDR/ IVDR and also withdraw from the services related to the MDD and IVDD.

20/07/2019

Performance evaluation, post-market surveillance and the IVDR

Performance evaluation, in keeping with Article 56 and Annex XIII, including the new post-market performance follow-up (PMPF) plan must be outlined within the QMS.

17/05/2019

Safety-engineered syringes

In 2015, the Who introduced a new policy on injection safety and asked that the worldwide community change to safety-engineered syringes by 2020 if possible.