MEDICAL DEVICES – EUROPEAN REGULATION 2017/745 – THE RULE 21: HOW THE CLASSIFICATION OF DEVICES COMPOSED OF SUBSTANCES IS GOING TO CHANGE

One of the main changes that will most affect the Medical Device regulatory field is included in Annex VIII of…

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REGULATORY AFFAIRS – NITROSAMINES: WHICH STEPS SHOULD BE TAKEN?

In June 2018, N-nitrosodimethylamine (NDMA) and similar compounds known as nitrosamines, classified as probable human carcinogen based on animal studies,…

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MEDICAL DEVICES– THE IMPLANT CARD FOR PATIENT WITH AN IMPLANTED DEVICE

Regulation EU 2017/745 introduced a new requirement for the manufacturer of implantable medical device. The manufacturers of implantable devices must…

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MEDICAL DEVICES – REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE

Starting with the entry into force of the new European Regulation 2017/745 on May 2020, the information on medical devices…

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MARKET ACCESS – NEW ITALIAN DECREE ON THE PROCEDURES FOR PRICING AND REIMBURSEMENT OF MEDICINAL PRODUCTS

On 1st August 2019, the text of a new Decree from the Italian Ministry of Health and the Ministry of…

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REGULATORY AFFAIRS – MANDATORY USE OF COMMON EUROPEAN SUBMISSION PORTAL FOR MUTUAL RECOGNITION PROCEDURE/DECENTRALIZED PROCEDURE

According to the eSubmission Roadmap, from July 1st 2019, the use of the Common European Submission Portal (CESP) has become…

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REGULATORY AFFAIRS – AIFA CLARIFICATIONS ON THE SUBMISSION OF MARKETING AUTHORIZATION TRANSFER APPLICATIONS OF NATIONAL MUTUAL RECOGNITION PROCEDURE/DECENTRALIZED PROCDURE FOR MEDICINAL PRODUCTS

AIFA clarifications on the submission of Marketing Authorization Transfer applications of national/MRP/DCP medicinal products With a recently published notice, on…

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MEDICAL DEVICES – EXTENSION OF THE APPLICATION FIELD AND MEDICAL DEVICES WITH NON-MEDICAL PURPOSES (Annex XVI)

The new European Regulation 2017/745 will bring many innovations. One of these concerns the extension of the Regulation application field….

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MEDICAL DEVICES – POST MARKET SURVEILLANCE: THE INTRODUCTION OF PERIODIC SAFETY UPDATE REPORT

As part of an ever-increasing improvement in post-marketing surveillance activities for medical devices, the new EU regulation 2017/745 introduces the…

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MEDICAL DEVICES – IMPACT OF THE NEW REGULATION ON MEDICAL DEVICES CONTAINING SUBSTANCES

Currently, many over-the-counter medical devices are substances or combinations of substances. Medical devices containing substances are the medical devices that…

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