MDR / IVDR final proposal was released in February this year, 

the medical device industry will undergo major changes

In February 2017, the Medical Device Regulations (MDR) and the In vitro Diagnostic Medical Device Regulations (IVDR) were finalized and the two regulations, once adopted by the European Parliament and the Council, would replace the existing three medical device directives. On September 26, 2012, the European Commission proposed amendments to the MDR and IVDR. In order to strengthen the quality of medical equipment supervision, to prevent the French poor breast augmentation silicone products into the market similar to a vicious incident again.
Medical Devices Regulation
MDR
Medical device regulations will be replaced:
Active Medical Device Directive (90/385 / EEC)
Medical Device Directive (93/42 / EEC)
After five years of revision, new regulations:
Audit of product safety and performance assessment documents will be more rigorous, including clinical evaluation and post-marketing clinical tracking
Requires better traceability of supply chain products
Strengthen the review of technical documents