EMERGO SUMMARY OF KEY POINTS:

• We analyze draft Medical Device and IVD Regulations that will replace current Medical Device Directives in Europe over the coming years.
• Ramifications of Brexit on how and whether CE Marking will continue to be used in the UK are not yet clear.
• A new MEDDEV updates clinical evaluation report (CER) recommendations in Europe.

Major medical device and IVD regulatory developments have occurred in Europe over the past few months. From publication of Medical Device Regulations (MDR) and IVD Regulations (IVDR) to substantial updates to clinical evaluation requirements to ramifications of Brexit, here are some key European market updates:

• After years of anticipation, European regulators have published draft regulations that will replace current medical device and IVD Directives.
• An initial Emergo analysis of the draft MDR identifies how—and in some cases, whether—manufacturers will be affected by new requirements.
• Emergo takes a first look at what the new IVDR will require from IVD manufacturers active in the European market.
• What does the UK’s “Brexit” vote to leave the European Union mean for CE Marking and related medical device regulations?
• The release of MEDDEV 2.7/1 updates guidance on clinical evaluation reports and processes required of some manufacturers.

For additional information and analysis on these significant European regulatory changes, download our whitepaper on the new MDR.