The EU’s regulatory rules for medical devices are due to change on 26 May 2020, when the new Medical Device Regulation (“MDR”)[1] comes into effect.  The regime for in vitro diagnostic devices will change two years later from 26 May 2022 when the In Vitro Diagnostic Devices Regulation (“IVDR”)[2] will apply.

In advance of these changes, the EU Medical Device Coordination Group (“MDCG”) has recently published guidance on the Qualification and Classification of Software in the MDR and IVDR (the “Guidance”).

The aim of the Guidance is to assist manufacturers with interpreting the new Regulations to assess whether their software meets the definition of a medical device or an in vitro diagnostic device (i.e., “qualification”); and if so, what regulatory class the software would fall under (i.e., “classification”).

The MDCG is a coordination group established under Article 103 of the MDR, comprising up to two medical device experts from each EU Member State.  Its key functions include contributing to the development of guidance to ensure effective and harmonized implementation of the EU’s new medical device rules.  The Guidance is not legally binding nor does it necessarily reflect the official position of the European Commission.  However, given the MDCG’s important role in the regulatory landscape, the Guidance is likely to be highly persuasive.


Continue Reading EU Medical Device Coordination Group Publishes Guidance on the Qualification and Classification of Software under Upcoming Medical Device Regulations

On 14 September 2017, the Committee for Human Medicinal Products (“CHMP”) of the European Medicines Agency adopted ICH Guideline E18 (the “Guideline”) on genomic sampling and the management of genomic data.  The Guideline takes effect on 28 February 2018.

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) developed the Guideline in acknowledgement of the growing awareness of, and interest in, genomic data generated from clinical studies.  The ICH suggested that the absence of a harmonized guideline made it more difficult to conduct genomic research consistently in global studies.  The fact that the CHMP has adopted the Guideline means that EU guidance on this subject is now aligned with the ICH standard.

The Guideline provides general principles for the collection and handling of genomic samples and management of genomic data.  It also affirms broader principles, such as the need for informed consent and the protection of subjects’ privacy etc.  The Guideline applies to both interventional and non-interventional clinical studies, irrespective of when the genomic research is carried out and whether it was envisaged in the study protocol.  The ICH/CHMP intend the Guideline to be interpreted in accordance with the law and policies in each jurisdiction where genomic research takes place.
Continue Reading CHMP Adopts Guideline on Genomic Sampling and Management of Genomic Data