IMPLEMENTING THE NEW MEDICAL DEVICES REGULATION: INDUSTRY CALLS FOR SOLUTION TO ENSURE CONTINUITY OF CARE TO PATIENT

MDD REGULATION TRANSITION TIME - STOP THE CLOCK (?)

MedTech Europe -  Original publisher

MedTech Europe is calling on the European Commission, European Parliament and all EU Member States, to have an urgent discussion of solutions that will ensure that there is appropriate time for the systems to be ready to function. The industry calls for:

• Actions to address challenges on the transition timing

Industry envisages at least three options to be explored either alone or in combination:

a) A ‘stop the clock’ mechanism, that freezes the remaining transition time for both regulations until full readiness of the system has been achieved;

b) An extension of the critical dates of 26 May 2020 and 26 May 2022, for all products;

c) An extension of the critical dates of 26 May 2020 and 26 May 2022, for legacy products only.

Options b) and c) would require a specific timeline to be agreed upon.

• Actions to make the ‘grace period’ an effective instrument and overcome the bottlenecks These could include, for example:

a) Extending its scope to include all products and particularly the legacy products;

b) Having a more feasible and flexible timing.

MedTech Europe is ready to cooperate with the EU institutions and all affected stakeholders to identify and deliver an optimal way forward. We urge all concerned parties in the strongest possible terms to act now, in the interest of patients and industry alike.

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BREXIT – ITS IMPACT ON REGULATORY ASPECTS OF HEALTH AND LIFE SCIENCES

From

website

"Much UK regulatory law originates from the EU. Most of it comes from EU Directives which the UK has implemented into our national law. Examples are Directive 2001/83/EC on the Community code relating to medicinal products for human use (as amended) and Directive 89/105/EEC, regulating the pricing of medicinal products for human use and their inclusion in national health insurance schemes. Some of it is derived from EU Regulations which are directly applicable in the UK, without the need for any implementing legislation here. An example is Regulation 726/2004 on the authorisation and supervision of medicinal products and establishing the European Medicines Agency.

This briefing considers some potential impacts of a vote to leave the EU (“Brexit”) on regulatory aspects of healthcare and life sciences."

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